Überblick über die Statistik des Gehaltsniveaus für "Manager Clinical Affairs in Deutschland"

Speculative application  Skills: Acne, Actinic Keratosis, Acute Myelogenous Leukemia (AML), AIDS, Allergic Rhinitis, Allergy, Alzheimer's, Anaesthetics, Antibiotics, Anti-infectives, Anxiety, arrhythmia, Asthma, Autoimmune diseases, Autoimmune Disorder, Bacterial Vaginosis, Breast Cancer, Cardiology, Cardiovascular, chemotherapy, Chronic Lymphocytic Leukaemia, Chronic Myeloid Leukemia, Chronic Obstructive Pulmonary Disease, Clinical Pathology, CLL, Congestive Heart Failure, COPD, Cosmetics, Cystic Fibrosis, Dementia, Dentistry, Depression, Dermatology, Diabetes, Diagnostics, Dietetics, Endocrine, Endocrinology, Epilepsy, Family Medicine, Fibromyalgia, Gastroenterology, gastrointestinal, Genetic Diseases, GI, Glioblastoma Multiforme (GBM), Gynaecologic, Gynaecology, Gynecology, Haematology, Haemophilia, Heart Disease, Hematology, Hemopure Anemia, Hepatitis, Hepatology, HIV, Hodgkin's disease, Hypertension, IBD, Immunogenicity, Immunopharmacology, Infections, Infectious Diseases, Influenza, Internal Medicine, Joint Replacement, Lymphoma, Mantle Cell Lymphoma, Melanoma, Menopause, Metabolic, Migraine, Multiple Sclerosis, Musculoskeletal, Myelodysplastic Syndrome, Neonatology, Nephrology, Neurodegenerative disorders, Neurology, Neuroscience, NEUROSURGERY, non small cell lung cancer, Non-Hodgkin Lymphoma, nutraceuticals, Nutrition, OA, Obstetrics, Oncology, Ophthalmology, Oral Health, Orphan Diseases, Orphan drug, Orthobiologic Bone graft, Orthopedic Surgery, Orthopedics, Osteoarthritis, Otitis Externa, Otolaryngology, Ovarian Cancer, Paediatric, Pain, Painful Diabetic Neuropathy, Parkinson’s Disease, Physiology, Podiatry, Post-Menopausal Osteoporosis, Primary Immune Deficiency, Primary Sjogren’s Syndrome, Prostate cancer, Prostatic hyperplasia, Psychiatry, Psychology, Pulmonary, Pulmonology, RA, Rare Disease, Respiratory, retinopathy, Rheumatoid Arthritis, Rheumatology, Rhinitis, Rosacea, Schizophrenia, Seasonal Allergic Rhinitis, Severe Hemophilia, Skin Melanoma, Sleep Disorder, Sleep Medicine, Small Lymphocytic Lymphoma, Small Molecule, Smoking Cessation, Solid Tumors, surgery, Systemic Lupus Erythematosus, Systemic Sclerosis, Tissue Ablation, Transplant, Trauma, Traumatology, Type 2 Diabetes Mellitus, Urology, Vaccine, Vaccines, Vascular Diseases, Weight Loss, Women’s Health, Administrative Assistant, Agile Project Manager, Artwork Coordinator, Associate Director Clinical Operations, Associate Project Manager, Auditor, Biomedical Engineer, Biometrics Manager, Biosample Operations Manager, Biostatistician, Biostatistics Associate Director, Brand Team Lead, Business Administration Associate, Business Administration Manager, Business Analyst, Business Development Associate, Business Development Director, Business Development Manager, CEO, Change Manager, Chemical Project Manager, Chemist, Chemistry, Manufacturing & Control Lead (CMC), Chief Financial Officer, Chief Operating Officer, Chief Technical Officer, Clinical Data Associate, Clinical Data Manager, Clinical Data Specialist, Clinical Development Manager, Clinical Engineer, Clinical Lead, Clinical Operations Director, Clinical Operations Manager, Clinical Pharmacologist, Clinical Programmer, Clinical Project Manager, Clinical Research Associate, Clinical Research Director, Clinical Research Manager, Clinical Research Physician, Clinical Research Specialist, Clinical Study Coordinator, Clinical Study Manager, Clinical Supply Coordinator, Clinical Supply Manager, Clinical Trial Assistant, Clinical Trial Educator, Clinical Trial Manager, Clinical Trial Specialist, CMC Manager, Commercial Manager, Communication Manager, Compliance Associate, Compliance Manager, Computer System Validation Specialist, Contract Associate, Contracts Manager, Country Manager, Customer Service Associate, Data Analyst, Data Analytics Assistant, Data Engineer, Data Management Associate Director, Data Management, Manager, Database Programmer_Designer, Demand Planner, Demand Manager, Developer, Diagnostic Specialist, Director of Contracts & Licensing, Dispensary Assistant, Document Specialist, Drug Safety Associate, Drug Safety Director, Drug Safety Manager, Early Access Project Manager, EHS associate, Electronic Data Capture Manager, Electrophysiologist, Employer Engagement Manager, Engineer (out of industry), Epidemiologist, Exploratory Project Manager, Feasibility Manager, Freelance, FSP Clinical Manager, Global Clinical Data Manager, Graduate, Head of Clinical Data Management, Head of Clinical Operations, Head of Risk Management, Health Economist, Health Information Associate, Healthcare Compliance Manager, HR Associate, HR Manager, Imaging Operations Lead, Inhouse Clinical Research Associate, Intern, Investigator, IT Project Manager, Junior Clinical Data Manager, Junior Clinical Research Associate, Junior Pharmacovigilance officer, Junior SAS Programmer, KOL, Laboratory Assistant, Laboratory Manager, Legal Advisor, Licensing Coordinator, Logistics Associate, Logistics Manager, Logistics Supervisor, Manufacturing Manager, Manuscript Editor, Market Access Manager, Market Access Specialist, Market Insights Specialist, Market Research Associate, Marketing Associate, Material Coordinator, Medical Advisor, Medical Assistant, Medical Devices Project Manager, Medical Director, Medical Information Assistant, Medical Information Associate, Medical Information Manager, Medical Manager, Medical Monitor, medical publisher, Medical Representative, Medical Research Associate, Medical Reviewer, Medical Science Liaison, Medical Technologist, Medical Writer, Medico-economic affairs, Meeting Coordinator, MHRA Pharmacovigilance Inspector, Microbiologist, Occupational Therapist, Office Manager, Ophthalmologist, Packaging Associate, Packaging Coordinator, Patient Recruitment Coordinator, Payroll Specialist, Pharmaceutical Physician, Pharmacist, Pharmacokineticist, Pharmacology Director, Pharmacovigilance Manager, Pharmacovigilance Officer, Physiotherapist, Planning analyst, Policy Officer, Post Doctoral Researcher, Preclinical Project Manager, Principal Biostatistician, Principal Scientist, Privacy Officer, Product manager, Production Manager, Production Specialist, Program Development Manager, Programmer Analyst, Programming Associate Director, Project Assistant, Project Manager (other industry), Proposal Developer, Psychiatrist, Psychologist, Publications Manager, QPPV, Qualified Person, Quality Assurance Assistant, Quality Assurance Complaint Specialist, Quality Assurance Director, Quality Assurance Manager, Quality Assurance Specialist, Quality Control Associate, Quality Control Manager, Quality Control Specialist, Quality Engineer, Quality Manager, Quality Specialist, R&D Manager, R&D Project Manager, Record Specialist, Recruitment & Screening Co-ordinator, Registration Specialist, Regulatory Affairs Administrator, Regulatory Affairs Associate, Regulatory Affairs Director, Regulatory Affairs Manager, Regulatory Affairs VP, Regulatory Documentation Scientist, Regulatory Information Specialist, Regulatory labelling specialist, Regulatory Program Manager, Regulatory Site Activation Manager, Remote Site Monitor, Senior, Research Coordinator, Research Funding Manager, Research Team Manager, Resources Manager, Respiratory Physiotherapist, Sales Manager, Sales Rep, Sample Manager, SAS Programmer, Scientific Advisor, Scientific Affairs Associate, Scientist, Senior Associate Supply Chain (GMP), Senior Biostatistician, Senior Clinical Lead, Senior Clinical Research Associate, Senior Clinical Supply Chain Associate, Senior Clinical Team Manager, Senior Clinical Trial Manager, Senior Epidemiologist, Senior Medical Affairs Officer, Senior Nutrition Scientist, Senior Regulatory Affairs Manager, Senior Scientist, Site Engagement Manager, Site Visit Report Reviewer, SOFTWARE DEVELOPER, Software Engineer, Start Up Director, Start-up Manager, Start-Up Specialist, Strategy Lead, Study Authorisation Associate, Study Delivery Operational Specialist, Submissions Manager, Supply Chain Coordinator, Supply Chain Manager, Supply Chain Planner, Surgical Technician, Systems Administrator, Technical Project Leader, Technical Services Specialist, Training Associate, Training Manager, Translator, Validation Engineer, Vendor Manager, Veterinary Nurse, Warehouse Associate, Warehousing & Distribution Leader, BSc, CQA, GMC, MBA, MBChB, MD, MPhil, MRCPsych, MSc, No CRA Certificate, PGDip, Ph.D Statistics, Pharm D, PhD, PRINCE2, Registered Nurse, SAP, Six Sigma, SolTRAQs, Veterinary, 3PL, ADaM, Administration, Adverse Event management, Advocacy plans, Agile, AKTA, Analytical SEC, Animal Health, APICS, Applicant Tracking System Management, APS, ARISg, auditing, Batch release, Batch Review, BHV, Bioequivalence, Bioinformatics, Biologic, Biomarkers, biometrics, Biosamples, Biosimilars, Biostatistics, Biotech, Black Belt, Business Development, C++, Candidate Attraction, CAPA, CDISC, Cell Biology, Cell stem-based therapy, CER, Chemstations, Client communication, Clinical, Clinical Affairs, Clinical Data Management, Clinical Programming, Clinical Research Organisation, Clinical Trial Applications, clinical trials, close out visits, CMC, CMO, Commercialisation, Compassionate Use, Competent Authorities, Computer Systems Validation, Contract, CPIM, CRF Design, CRO, CSR, Data Analysis, data entry, Data Science, Data Warehouse, database design, Datalabs, DHPC, Distribution, Distribution Planning, DMC, Document Management, Downstream, Drug destruction, Drug Development, Drug Safety, DSUR, E2E, Early Access, Early Phase, EC Submissions, ECG, eCRF, EDC, electronic data capture, ELISA, Epidemiology, ePRO, ERP, eTMF, e-TMF, EU Legislation, Eudravigilance, European Federation of Pharmaceutical Industries, Export Management, FDA Audits, Feasibility, Finance, Forecast, FPLC, GCP, GDP, Gene Therapy, Global, Global Regulatory Affairs, GLP, GMP, Government Affairs, GS1 standards, Health Economics, Healthcare, Healthcare Compliance, Healthy Volunteers, Home-based, HPLC, IATA, ICF, ICH-GCP, Imaging, Immunology, IMP, IMPACT, IMPD, Import Management, IND, InForm, Informatics, International, Interviewing, Inventory Management, Investigator Payments, in-vitro, in-vivo, IRB Submissions, IRT, ISO 13485, ISO 13485:2003, ISO 14971, ISO 9001, ISO13485, IVRS, Java, Lab, Labelling, Laboratory, LEAN, Line Management, Logistics, MA-CC, Manufacturing, MAPP, Market Access, Market Insights, Market Intelligence, Market Research, Marketing, Marketing authorizations, Materiovigilance, MedDRA, Medical Affairs, Medical Communication, Medical Devices, Medical Information, Medical Writing, Medidata Rave, Monitoring, Monitoring Visit, MS Office, MS Project, My Trials, NMR, Office-based, Oracle, Outcomes Research, Outsourcing, Packaging, Paediatrics, Patient Outcomes, Permanent, PET scans, Pharma, Pharmaceutical, Pharmacodynamics, Pharmacoeconomics, Pharmacoepidemiology, Pharmacokinetic, Pharmacokinetics, Pharmacology, Pharmacovigilance, Pharmacy, Phase I, pipetting, PMP, Policy, Post Marketing, Postdoctoral research, Post-marketing, Preclinical, Pricing & Reimbursement, Pricing and Reimbursement, PROC, Process Excellence, Procurement, Product Management, Project Leadership, Project Management, PromoMats, Protein Characterisation, protocol development, Protocol writing, PSURs, Public Affairs, publishing, Purchasing, QP, Qualification Visit, Quality Assurance, Quality Control, Quality Management, Quality Management System, Radiology, Randomisation, Randomization, Rave, Reactovigilance, Real World Evidence, Recruitment, Regional Monitoring, Regulatory, Regulatory Operations, Regulatory submissions, Regulatory Systems Management, remote monitoring, RFI, Risk Management, risk-based monitoring, RMA, RMP, SAE, SAE reporting, Sales Inventory, Sample size estimation, Samples, SAS, Scrum, SDS-PAGE, SDTM, Serialisation, Shipments, shipping, Simoa, Site contracts, Site Engagement, site payments, SOX, SPC- CCDS, Spectroscopy, S-Plus, SPSS, SQL, Start-up activities, statistical analysis, Statistics, Study Management, Study Medication Labelling, Sunshine Act, Supplier Qualification, Supply Chain Distribution, Supply Chain Management, Supply Chain Planning, Supply Planning, SUSAR, SUSARs, TMF, Toxicogenomics, Toxicology, Trackwise, Training, Transport Management, Unicorn Purification System, UPLC, Upstream, UV-Vis Spectroscopy, validation, Veeva, Vendor Management, Venipuncture, VISIO, Western Blot, ZINC, Bratislava, Slovakia, Afrikaans, Argentinian, Armenian, Belgian, Bosnian, Bulgarian, Cambodia, Cantonese, Catalonian, Chinese, Croatian, Czech, Danish, Dutch, English, Flemish, French, Greek, Gujarati, Hebrew, Hungarian, Italian, Japanese, Korean, Latvian, Lithuanian, Luxembourgish, Macedonian, Malayalam, Mandarin, Montenegrin, Norwegian, Persian, Punjabi, Romanian, Russian, Serbian, Slovak, Slovene, Slovenian, Spanish, Swedish, Thai, Turkish, UkrainianLocation: GloballyShare: 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Location: Europe - home-basedSchedule: Full-time, Permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture.  We are recruiting for a dynamic person to join our in-house team as a Director of Business Development - PV, MA & RA Services. You will be responsible for lead generation, opportunity assessment, creating new accounts, and growing existing accounts. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Identify, assess, and pursue new business opportunities.Build and maintain positive relationships and provide regular face time with key decision makers within prospect and client organizations.Develop a deep appreciation for the client's business challenges and organizational structure and use this insight to develop realistic and actionable account plans.Contribute to the ongoing refinement of the company's business development approach, defining client and vertical targets, minimizing the cost of sales, and increasing both efficiencies and closing rates.Work to exceed revenue targets that align with the company's growth objectives. Education and Experience:6+ years of sales and account management experienceExperience in functional and consultancy sales with a particular focus on Product Safety, Pharmacovigilance, Medical Affairs, and/or Regulatory AffairsEstablished a network of decision-makers in the life-sciences industry.Experience selling to, presenting to, and building relationships with senior management and C-level stakeholders.Strong negotiation skills with a proven track record of closing complex business dealsPersuasive and compelling presentation and communication skills, both written and verbalAbility to interpret business challenges and present quick and responsive high-level solutions.Deadline-driven with a proven ability to manage multiple engagements at varying points in the sales cycle.Positive employer and client referencesBA, MBA, or equivalent experience The Application ProcessOnce you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step.  If you would like to discuss the role before applying through the website @ www.cromsource.com/careers/job-vacancies please contact [email protected] for more information. Who will you be working for? About CROMSOURCE   CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                Our Company EthosOur employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry-average turnover rates. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Director of Business Development, business development, marketing, contracting, travel, clinical trials, CRO, Clinical Research Organization, clinical development, CRO management, relationship management, clinical research sales, account managementSkills: Business Development Director, Business Development Manager, Clinical Research Associate, Business Development, clinical trials, CROLocation: EuropeShare: LinkedIn Facebook Twitter Email

Location: Poland - home-based    Schedule: Full-time, permanent         CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.         As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.       Join our team and help us deliver clinical trials that will improve patients' lives.         Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Masters degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in Poland:Internet compensation of up to PLN 80 per monthInsurances: Group Accident (employer funded), medical care, and social fund (as per Polish regulations)PPK Pension participation (as per Polish regulations)Meal VouchersFlexible working hoursOccasional work from homeHolidays: Between 20 and 26 days per year, depending on seniorityRefund on corrective glasses for computer work (as per Polish regulations)Annual Christmas partySeniority Bonus (5y-1.000PLN, 10y-2.000PLN,15y-3.000PLN, 20y-4.000PLN)  The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.      If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact [email protected] for more information.         Who will you be working for?         About CROMSOURCE          CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                          Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Strategy Lead, CMC, CRO, Outsourcing, Regulatory, Regulatory OperationsLocation: PolandShare: LinkedIn Facebook Twitter Email

Location: Spain - home-based    Schedule: Full-time, permanent         CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.         As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.       Join our team and help us deliver clinical trials that will improve patients' lives.         Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Master's degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in Spain:Competitive SalaryHealth insuranceHome office allowanceMeal vouchers23 days of holiday per year + 2 convenio days and bank holidays  The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.      If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact mailto [email protected] for more information.     Who will you be working for?         About CROMSOURCE          CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                          Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Strategy Lead, CRO, Outsourcing, Regulatory, Regulatory OperationsLocation: SpainShare: LinkedIn Facebook Twitter Email

Location: Italy - home-based    Schedule: Full-time, permanent         CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.         As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.       Join our team and help us deliver clinical trials that will improve patients' lives.         Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Masters degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in Italy:Meal vouchersMobile phone if requested by the Line ManagerDedicated Line ManagerMonthly meetings with the line managerFull performance and development process with end-of-year reviews  The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.      If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact [email protected] for more information.         Who will you be working for?         About CROMSOURCE          CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                          Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Strategy Lead, CMC, CRO, Outsourcing, RegulatoryLocation: ItalyShare: LinkedIn Facebook Twitter Email

Location: Netherlands - home-based    Schedule: Full-time, permanent     CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.       As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Masters degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in the Netherlands:Competitive SalaryGroup health insuranceGreat pension scheme24 vacation days (but up to 30 days, depending on negotiation)Internet reimbursementCompany Car with fuel card depending on the function.Full performance and development process with end-of-year reviews The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.    If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact [email protected] for more information.         Who will you be working for?         About CROMSOURCE         CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                        Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Regulatory Affairs Director, Strategy Lead, Clinical Research Organisation, CRO, Regulatory, Regulatory OperationsLocation: NetherlandsShare: LinkedIn Facebook Twitter Email

Location: Germany - home-based    Schedule: Full-time, permanent         CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.         As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.       Join our team and help us deliver clinical trials that will improve patients' lives.         Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Masters degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in Germany:30 Euro net Internet cost reimbursement per monthAdditional Accident Insurance, fully covered by the company25 vacation daysPossibility of salary conversion for additional pension insuranceDedicated Line Manager The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.      If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact [email protected] for more information.         Who will you be working for?         About CROMSOURCE          CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                          Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Regulatory Affairs Director, Strategy Lead, Clinical Research Organisation, CRO, Regulatory, Regulatory OperationsLocation: GermanyShare: LinkedIn Facebook Twitter Email

Location: Belgium - home-based    Schedule: Full-time, permanent     CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.       As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Masters degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in Belgium:Competitive SalaryGroup and hospitalisation insuranceElectronic meal vouchersInternet reimbursementCompany Car with fuel card depending on the function.Dedicated Line Manager The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.    If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact [email protected] for more information.         Who will you be working for?         About CROMSOURCE         CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                        Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Regulatory Affairs Director, Strategy Lead, Clinical Research Organisation, CRO, Regulatory, Regulatory OperationsLocation: BelgiumShare: LinkedIn Facebook Twitter Email

Location: Belgium - Hybrid  Schedule: Full-time, permanent     Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds….       TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Clinical Research MD to join one of our clients, one of the most innovative pharmaceutical companies in the world.     CROMSOURCE is an international CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently while establishing a high-trust environment with their client counterparts.       The Clinical Research MD is a responsible member of a clinical team dedicated to the execution of medical strategies and the clinical and operational implementation of a clinical study. Provides active medical and scientific contributions to a cross-functional clinical team.The Physician provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, and contributes to the content of clinical study reports and relevant documents for regulatory filings, and performs medical monitoring. Team matrix interactions include clinical team members, project management, quality assurance, quality monitoring and compliance, clinical supplies unit, TA strategy, regulatory affairs, data management, medical writing, biostatistics, global medical affairs, clinical pharmacology, clinical operations, health economics, epidemiology, and other scientific and business-related disciplines.Main Job Tasks and Responsibilities: Is responsible for medical monitoring/reporting and company safety officer activities.Works on clinical development plans, and trial protocols and contributes to clinical study reports.Evaluates adverse events (pre- and post-marketing) for relationship to treatment.Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting.Interprets, reports, and prepares oral and written product research findings in conjunction with senior clinical staff in preparation for regulatory submissions.Liaises closely with clinical scientists and physicians across programs.Provides medical input to external activities such as liaison with external experts, steering committees, independent data, Monitoring Committees, and other committees related to studies or projects.Medical input related to trial-related questions.Provides medical training to the Clinical Trial Team members and other company stakeholders.Supervises Clinical leader.Assists Regulatory Affairs in the development of drug regulatory strategies.Supports general clinical activities involving product evaluation, labeling, and surveillance.Reviews medical literature and related new technologiesAssess medical publications emerging from the Team and its affiliates. Education and Experience:MD with four years' experience in clinical development in pharma or biotech, or equivalent in Academia, preferably including medical monitoring.Trained in GCP Good knowledge of regulatory requirements/ICH guidelines.Proficient in using Microsoft Office and in data visualization tools.Good organizational skills, able to work as part of a team and independently.Good communication skillsDetailed orientedEnglish oral and written communication skills Our Benefits in Belgium:Competitive SalaryGroup and hospitalization insuranceElectronic meal vouchersInternet reimbursementDedicated Line ManagerRegular face-to-face or phone meetings with the line managerFull annual performance review process The Application Process   Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.    If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected] for more information.     Who will you be working for?      About CROMSOURCE        CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                      Our Company Ethos   Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry-average turnover rates.     About TalentSource Life Sciences    TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.     CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.     Keywords: Clinical Research MD, Physician, CRO, Clinical Research Organisation, Contract Research Organisation, Clinical, Drugs, Medical Devices, Clinical TrialsSkills: Medical Practitioner, Clinical Research Organisation, clinical trials, CRO, Medical DevicesLocation: BelgiumShare: LinkedIn Facebook Twitter Email

Abiomed is an innovative medical device business with an inspiring mission "Patients First," and a unique guiding company principle " Recovering hearts. Saving lives." With more than 2,000 employees, Abiomed is one of the fastest growing medical technology businesses in the world with corporate headquarters in Danvers, USA, and locations in Aachen and Berlin, Germany, Tokyo, Japan, and Singapore. Abiomed is part of Johnson & Johnson MedTech.Abiomed is an employer with attractive working conditions and an appreciative corporate culture that focuses on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development. Medical Science Liaison (d/f/m) Medical Device - Region South Germany, Austria & Switzerland This role reports to the Associate Director Medical Affairs EMEA. The Medical Science Liaison will manage the regional efforts of the Medical Affairs group within the European Medical Affairs Team. The Medical Science Liaison is responsible for supporting the EMEA Abiomed Business in establishing highest medical-scientific credibility with our customers. The Medical Science Liaison shall act as a scientific expert between Abiomed and the medical community through the communication of scientific evidence-based data and serves as an expert consultant to internal cross-functional partners within Abiomed by providing product related, evidence-based information, including educational support to the Sales and Marketing groups. This position is key to sharing and deepening the clinical understanding of cardiac unloading and heart recovery in the specialist community. Principle Duties & Responsibilities Serves as an expert resource on Abiomed's product's scientific and clinical evidence and associated disease states to the Company, specifically the Commercial Organization, implementing the company's scientific communication strategy on a regional level through regular field visits and collaboration Serves as an information source to physicians and researchers through dissemination, clarification and education of scientific clinical evidence. Responsible for external speaker approval and qualification using the most current scientific and clinical information including quality control. Medical Science & Therapeutic area knowledge Maintain extensive clinical/scientific expertise as a subject matter expert of the relevant therapeutic areas, products, company pipeline, medical technology and competitor Maintain understanding of medical device development methodology, marketing and market access concepts, health care reimbursement to be able to collaborate with business partners. Scientific communication Develop peer-level relationship networks with thought leaders, professional groups, organizations, decision makers and other key stakeholders in cardiovascular diseases in the assigned geography. Share and discuss evidence-based scientific data with stakeholders in accordance with company guidance Part of the Physicians team in the Medical Office to support the Clinical Support Center and Field Team in patient support cases, also responding to unsolicited questions as appropriate through 'one on one' contacts and group presentations Facilitate education on disease state, product pipeline and competitor products to internal stakeholders and external customers as appropriate. Your Expertise Medical Degree with ideally 2-5 years of experience in the Medical Device Industry Proven understanding of the medical device and healthcare system requirements Analytical skills and capability to understand, interpret, and communicate complex scientific information Excellent verbal and written communication skills and fluency in English. Another European language is an advantage Excellent interpersonal skills, Ability to communicate effectively with Thought Leaders Strong team player and mature personality that works effectively on cross-functional teams, with medical and non-medical professionals at all levels and in an international environment Excellent organizational and managerial skills with proven track record in the organization of medical-scientific events Ability to travel nationally and internationally approximately 80% of the time Language proficiency in German & English Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sex, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace. Über das Unternehmen:Johnson and Johnson

Location: Belgium - Office-basedSchedule: Full Time, Permanent Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds….   The sponsor-dedicated division of ClinChoice, is searching for a Regulatory Compliance Specialist to join one of our clients, one of the most innovative pharmaceutical companies in the world. ClinChoice is an international CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with their client counterparts.   The Regulatory Specialist assists and supports the Regulatory Affairs department in the execution of regulatory activities to ensure the timely global commercialization of products in compliance with applicable European regulations and international standards.Main Job Tasks and Responsibilities: Partner with the International execution team in the EMEA region.Coordinate, compile, and submit free distribution certificates.Support product registration internationally; Gather and collate information from the manufacturer as required.Provide support to the international team as requested in the development of relationships with RA affiliates, contribute to the development and implementation of the local registration strategy.Act as the EU regulatory Subject Matter Expert for the portfolio under his or her responsibility, supporting the day-to-day Regulatory Affairs activities.Develop strategic guidance and recommend regulatory requirements relevant to the Franchise.Review internal and external communications of the EMEA that refer to products and/or disease state information (Copy Review Process) and represents the department in relevant forums.Advise and provide regulatory impacts to Supply Chain initiatives for the department, be the Primary Point of Contact for the regulatory distribution controls of medical devices and support associated processes and system development.Write, review, and revise company SOPs, recommend efficiencies to processes, and drive Engineering Change Orders (including but not limited to SOPs, and EU labeling approval).Support announced and unannounced inspections by external and internal functions.Assist with organizational tasks: departmental meetings (logistics, formatting, minutes) and department POs, handling regulatory fees (Ariba).Work closely with internal partners across the organisation (including Legal manufacturers, importers, distributors, regional regulatory affairs, quality, supply chain, marketing, and medical affairs) to ensure that stakeholder voices are incorporated into strategies for product launches and product changes.Provide solutions to a variety of problems of moderate scope and complexity where data analysis requires the evaluation of intangible variables.Responsible for the communication of business-related issues or opportunities to the next level of management.Responsible for ensuring personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.Perform other duties assigned as needed.  Education and Experience: University/bachelor's Degree or Equivalent (Science, Engineering, Technical or Biomedical field or Law preferred).4-6 years of work experience in Regulatory Affairs or Quality Affairs preferredSkills:Good knowledge of medical device regulatory requirements in the EUAbility to work effectively in a matrixed organisation and to build partnerships with regional and franchise colleagues.Demonstrate project management skills.Proactive identification of new insights and solutionsExcellent communication, influencing, and presentation skills.Strong output orientation and sense of urgencyExcellent written and verbal communication skills in English (required) The Benefits of Working in Belgium:Competitive SalaryGroup and hospitalisation insuranceElectronic meal vouchersInternet reimbursementCompany Car with fuel card depending on the function.Dedicated Line Manager The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected] for more information. Who will you be working for?   About ClinChoice      CROMSOURCE is now a ClinChoice Company. ClinChoice is a leading full-service CRO dedicated to offering high-quality one-stop service to the pharmaceutical, biotechnology, medical device and consumer products clients. Some of these services include Clinical Operations, Project Management, Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, and Pharmacovigilance. ClinCHoice has established major delivery centres across US, Canada, China, Europe, India, Japan and the Philippines. It has over 4,000 employees globally, with a strong and talented team, and a growing clinical operations presence across Asia, North America, and Europe.      Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. Keywords: Regulatory Compliance Specialist, RA, Compliance Specialist, Regulatory Specialist, Medical Devices, Regulatory, Regulatory Affairs, Pharmaceutical, Pharma, CRO, Contract Research Organisation, Outsourced, Sponsor-dedicatedSkills: Regulatory Affairs Associate, CRO, Medical Devices, Outsourcing, Pharma, Pharmaceutical, Regulatory, Regulatory OperationsLocation: BelgiumShare: LinkedIn Facebook Twitter Email

Location: Baden-Württemberg Germany - Site-basedSchedule: Freelance - 0.5 FTE   Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds…   The sponsor-dedicated division of ClinChoice, is searching for a Clinical Study Nurse to join one of our clients.   ClinChoice is an international CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with their client counterparts.     Main Job Tasks and Responsibilities: Assists project teams with study-specific documentation as appropriate.Completion of Case Report Forms (CRFs/eCRFs) and Data Clarification Forms (DCFs).Tracking and Quality Control, maintaining drug accountability records, completion of site status reports.Ensures that review source documents e.g. laboratory reports are reviewed and signed by The Investigator.Understand ICH GCP, relevant regulations, and site SOPs.The maintenance of the study files and the databases for the project.Co-coordinates ordering/dispatch and tracking of trial materials.Assists project teams with trial progress tracking and updating distribution tasks by updating the Clinical Trial Management systems.Supports for tracking and safety reporting of study progress.Provides activity reports expenses and timesheets to the Company.Reporting of adverse events (AEs) serious adverse events (SAEs) to all relevant personnel parties.Entering data into the eCRF.Working with the Clinical Research Associate (CRA) to resolve queries.Adhering to the site and study-specific protocol training whilst undertaking visit duties.Maintaining standards of professional competence and current clinical practices under ICG_GCP, EU Clinical Trials Directive EU2001/20EC and German Regulatory Requirements.Completing study visits at the site in line with the study protocol requirements.Provision of excellent standards of service provision following study protocol training and country-specific requirement.Adhering to the Sponsor/Site training and study-specific protocol training, whilst undertaking visit duties.Ensures that all relevant information regarding subjects is recorded, reported and where necessary, acted upon the communicate any changes to the Investigator study team as appropriate.Working at site and Patient Services team and Country Lead to ensure that all aspects of service for assigned groups of subjects are met, through the adherence to study schedules, protocols, and local clinical practice regulations and requirements.Flexible approach to working hours to accommodate the dynamic nature of research visits. Education and Experience:Registered Nurse or Medical Assistant with at least 2 years of post-registration experiencePrevious experience as a Research Nurse or Medical Assistant including a recent (within the last 1 year) ICH-GCP update.Experience in neurology is desirable. Skills Requirement:Measurement of vital signs (i.e., blood pressure, pulse rate, BMI, etc.).Performing ECG.Drawing of blood.Performing the infusion including putting on the infusion tubes and clinical monitoring during/after infusion (following training).Ship blood/laboratory samples to the central lab (training and instructions will be provided).Check questionnaires.Report AEs/SAEs.Liaise with the study team.Enter visit data into eCRF.Database screening.Discuss study information with subjects to aid informed consent.Coordinates all participant visits including inviting study participants, coordinating the visits with the pharmacy, the neuroimaging unit, the local lab, and the home health.Coordinates accounting for travel expenses of study participantsAssists the Principal Investigator (PI) in determining subject eligibility.SAE reporting through safety gateway.Make eCRF entries/corrections/resolve DCFs…Selection and randomisation procedures using IRS.Communicate with IEC.Maintain documentation in the Investigator Site File.Infusion experience essential.Good phlebotomy skills.ECG recording.Managing infusion reactions.Demonstrated organisational skills.Proven flexibility and the ability to work under pressure.Good communication skills.Proficiency in German mandatory, English desirable.Proactive contribution towards the team by being a flexible team player.Ability to work effectively both in a team & independently in a fast-paced environment.Excellent understanding of the clinical processes.Good knowledge of clinical trials, including EU Clinical Trials Directives, Good Clinical Practice for Clinical Trials, and German regulations is desirable, training can be provided.Excellent computer skills required, MS Office proficiency at a minimum. The Application Process  Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @  https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected] for more information.     Who will you be working for?     About ClinChoice       CROMSOURCE is now a ClinChoice Company. ClinChoice is a leading full-service CRO dedicated to offering high-quality one-stop service to the pharmaceutical, biotechnology, medical device and consumer products clients. Some of these services include Clinical Operations, Project Management, Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, and Pharmacovigilance. ClinCHoice has established major delivery centres across US, Canada, China, Europe, India, Japan and the Philippines. It has over 4,000 employees globally, with a strong and talented team, and a growing clinical operations presence across Asia, North America, and Europe.        Our Company Ethos  Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.     Keywords:  Study Nurse, Research Nurse, Trial Nurse, MS Office, German, Pharmaceutical, Pharma, CRO, Contract Research Organisation, Outsourced, Sponsor-dedicatedSkills: Nurse, Registered Nurse, Clinical Research Organisation, clinical trials, CRO, MS Office, Pharma, PharmaceuticalLocation: GermanyShare: LinkedIn Facebook Twitter Email

GSK’s portfolio spans three product areas: vaccines, specialty and general medicines and our focus is to deliver better and faster for patients globally. Our unrivalled vaccine portfolio targets infectious diseases at every stage of life, helping to reduce the burden of disease for hundreds of millions of people. GSK has exceptional capabilities in vaccine science and technologies, including adjuvant/protein and mRNA. In specialty medicines, we are at the forefront of HIV prevention and treatment, and we are building our presence in key therapeutic areas such as oncology and immuno-inflammation. General medicines include our inhaled medicines for asthma and COPD, antibiotics, and medicines for skin diseases. By 2031, we aim to deliver more than £33 billion in annual sales – a step-change in performance and growth which will significantly increase the positive impact we can have on the health of billions of patients around the world. And we’re confident in our future. Our pipeline of 21 vaccines and 43 medicines includes many with potential to be first or best-in-class opportunities for patients. Medical Science Liaison - Hematology (m/f/d) Medical Affairs is a critical bridge between R&D and the commercial organization to ensure that our medicines reaches the appropriate patients. The MSL Manager is a critical role to ensure oncology resource and activities are aligned and deployed to business priorities and patient needs. The function is crucial to build up scientific expertise to provide greater insight and significant external presence. Region: Baden-Württemberg Key Responsibilities This role will provide you the opportunity to lead key activities as follows: Creating and forming measures and programs out of the medical strategy within their designated scope, schedule, and resources Management of all medical affairs activities in the territory Development, implementation and project lead of medical scientific projects Identification and support of relevant study centres and cooperation partners and intensification of scientific dialogues (discussion of latest publications, data and therapies; scientific presentation and moderation of advisory boards / symposiums; …) Acting as a partner of choice and consultant for all external KOL´s and HCP´s Support of clinical research programming across the continuum (Investigator sponsored research, Cooperative Group and Collaborator research, Company Sponsored trials) Partnering within all areas of GMA (e.g. Medical Directors, Medical Communications, Medical Information, Publications, Patient Advocacy) and support as content expert for Clinical Research, Sales, Marketing, Market Access, Patient Advocacy, Communications Qualifications & Skills We are looking for professionals with these required skills to achieve our goals: Accredited doctorate degree in a life-science or basic-science discipline (Pharm.D., D.Sc., D.N.P., Ph.D., or M.D./D.O.) Clear evidence of Oncology experience - preferably within last few years Demonstrated understanding of the European healthcare environment, including knowledge of health technology assessments and market access challenges as well as understanding of Pharmaceutical ethics and governance, of pharmaceutical compliance policies and procedures Expert public speaking and written communication skills Successful and superior influencing skills across all levels of the organization and with external collaborators Problem solving and risk-mitigation skills Fluency in English and German Willingness to travel extensively Preferred Qualifications & Skills If you have the following characteristics, it would be a plus: Demonstrable experience and success in MSL organizations in therapeutic oncology Prior experience with product launches Financial and budget management Find out more: Annual Report 2022 Product Pipeline #EBDE Why Us? GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site. We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.Über das Unternehmen:582 GlaxoSmithKline GmbH & Co. KG

Das sind Ihre neuen Aufgaben Von der Planung bis zur Durchführung und Bewertung betreuen Sie die regulatorischen und wissenschaftlichen Aufgaben zur Erbringung der notwendigen klinischen Nachweise für unsere IVD-ProdukteFür die Entwicklung und Leistung unserer IVD-Produkte ermitteln Sie klinische bzw. diagnostische KriterienSie erarbeiten produktspezifische klinische Bewertungsstrategien inkl. statistischer Elemente bei der Planung klinischer Leistungsstudien, stellen die Einhaltung der Pläne sicher, bewerten Änderungen, werten resultierende Daten entsprechend aus und fassen die Ergebnisse in Berichten für die technische Dokumentation zusammenBei der Durchführung der Leistungsstudien stellen Sie die Einhaltung regulatorischer und ethischer Anforderungen sicherDarüber hinaus sind Sie bei der Weiterentwicklung unserer Prozesse zur klinischen Leistungs bewertung sowie zur Analyseleistung beteiligtFür Ihre Kollegen in anderen Fachbereichen, z.B. Entwicklung und Produktmanagement, sind Sie wichtiger Ansprechpartner für Fragestellungen zu Leistungsdaten und durchgeführten Studien Das zeichnet Sie aus Ihr Masterstudium der Ingenieur- oder Naturwissenschaften wie z. B. Medizintechnik, Biologie oder Biotechnologie haben Sie erfolgreich abgeschlossen und idealerweise um eine Promotion im Fachgebiet Immunologie ergänztSie bringen mehrjährige Berufserfahrung im regulatorischen Bereich eines IVD- oder MDR-Herstellers und der Durchführung von analytischen und klinischen Studien mit; idealerweise können Sie zusätzlich Erfahrung mit dokumentierter Literaturrecherche und Statistik vorweisenMit Ihrem analytischen Denkvermögen und Ihrer strukturierten Arbeitsweise fällt es Ihnen leicht, komplexe Sachverhalte schnell zu erfassen und aufzubereitenIhre sehr guten Deutsch- und Englischkenntnisse wenden Sie bei der Dokumentation und im Austausch mit unseren ausländischen Niederlassungen sicher anDank Ihrer Kommunikationsstärke und einem ausgeprägten Teamgeist können Sie zwischen den Fachabteilungen gut vermitteln und Ihren Kollegen als kompetenter Ansprechpartner stets weiterhelfen Das erwartet Sie Ein sicherer Job für die Zukunft - Unbefristete Arbeitsverträge in einer krisensicheren und zukunftsorientierten BrancheEin gutes Gleichgewicht zwischen Beruf und Freizeit - Flexible Arbeits- und Pausenzeiten rund um die Kernarbeitszeit, Stundenkonto, 30 Urlaubstage, mobiles Arbeiten (nach Absprache möglich)Kollegen, bei denen man sich wohl fühlt - Familiäre Arbeitsatmosphäre, Du-Kultur auf allen Ebenen, Onboarding und Patenprogramm, TeameventsGute Arbeit zahlt sich aus - 13 Gehälter, Mitarbeiterempfehlungsprogramm, übergesetzliche Zuschüsse zu Ihrer AltersvorsorgeGesundheit ist das höchste Gut - Ausgewogene Ernährung im Betriebsrestaurant, Getränkeflatrate, Betriebsarzt, Physioservice und Massagen, diverse FirmensportgruppenViel Abwechslung, auch nach Feierabend - Mitarbeiterveranstaltungen, Kreativ-Workshops, Sonderkonditionen für Veranstaltungen, Rabattaktionen für Produkte und DienstleistungenFeedback, das gehört wird - Jährliche Mitarbeitergespräche, regelmäßige MitarbeiterbefragungenUnd vieles mehr! Standort EUROIMMUN Medizinische Labordiagnostika AG, Lübeck

The PositionA healthier future. That’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.With a department of more than 100 biostatisticians, data scientists and data managers at the Roche sites in Penzberg, Mannheim, Indianapolis and Sant Cugat des Vallès, we are supporting global projects to deliver new diagnostics to patients.As a Biostatistician / Data Scientist (f/m/d) in Personalized Healthcare, you and your future colleagues will focus on applying state-of-the-art statistical and data science methods to drive innovative projects in the field of personalized healthcare and companion diagnostics.Your key responsibilitiesYou will work as a project statistician and support the development of new biomarkers.You are responsible for planning and analyzing analytical and clinical studies.You will interact closely with the project team members (R&D, Clinical Operations, Clinical Development, Regulatory Affairs, external cooperation partners and customers) to capture data analysis requirements and to interpret and communicate the results in an understandable way.You will have the opportunity to apply multivariate machine learning methods for the development of new clinical algorithms.Your profileUniversity degree in (bio)statistics or related subjects (e.g. mathematics, epidemiology, physics), ideally with a PhD and extensive experience in statistics.You have experience in the life science/diagnostics/pharmaceutical industry or have successfully completed clinical data analysis projects in an academic environment.You are familiar with common diagnostic and statistical methods (e.g. logistic regression, ROC analysis, cut-off determination) and have experience in the design, analysis and evaluation of analytical and clinical studies.You have experience with statistical methods such as classification, survival and longitudinal analysis models and you are enthusiastic about the application and implementation of new statistical methods.You have excellent knowledge of R and LaTeX, ideally knitr or R markdown.You have excellent communication, organization and documentation skills as well as very good written and spoken English. German is an advantage.This position is a 2-year temporary contractYour applicationWe make things easier for you: Please upload only your current and informative CV and your certificate of your highest degree. However, we are happy to receive additional documents, such as a letter of motivation and certificates, which will help us to find out more about the reasons for your application.We look forward to receiving your application!Your contact to us! With people. For people.Do you need more support? Our Talent Acquisition Team welcomes your questions. Please send an email to**********Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Roche at Penzberg, near Munich, employs more than 7,000 people. The site is one of the largest biotechnology centers in Europe and the only Roche site with research, development and production for both Pharmaceuticals and Diagnostics under one roof. From your beginning with Roche, our motivated team will welcome and support you. Numerous opportunities for personal development, flexible work hours, attractive compensation packages and special family assistance programs are available.Roche is an Equal Opportunity Employer.Über das Unternehmen:6164 Roche Diagnostics GmbH

Abiomed is an innovative medical device business with an inspiring mission "Patients First," and a unique guiding company principle " Recovering hearts. Saving lives." With more than 2,000 employees, Abiomed is one of the fastest growing medical technology businesses in the world with corporate headquarters in Danvers, USA, and locations in Aachen and Berlin, Germany, Tokyo, Japan, and Singapore. Abiomed is part of Johnson & Johnson MedTech.Abiomed is an employer with attractive working conditions and an appreciative corporate culture that focuses on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development. Medical Science Liaison (d/f/m) Medical Device - Region Germany North-East This role reports to the Associate Director Medical Affairs EMEA. The Medical Science Liaison will manage the regional efforts of the Medical Affairs group within the European Medical Affairs Team. The Medical Science Liaison is responsible for supporting the EMEA Abiomed Business in establishing highest medical-scientific credibility with our customers. The Medical Science Liaison shall act as a scientific expert between Abiomed and the medical community through the communication of scientific evidence-based data and serves as an expert consultant to internal cross-functional partners within Abiomed by providing product related, evidence-based information, including educational support to the Sales and Marketing groups. This position is key to sharing and deepening the clinical understanding of cardiac unloading and heart recovery in the specialist community. Principle Duties & ResponsibilitiesServes as an expert resource on Abiomed’s product’s scientific and clinical evidence and associated disease states to the Company, specifically the Commercial Organization, implementing the company’s scientific communication strategy on a regional level through regular field visits and collaborationServes as an information source to physicians and researchers through dissemination, clarification and education of scientific clinical evidence. Responsible for external speaker approval and qualification using the most current scientific and clinical information including quality control. Medical Science & Therapeutic Area KnowledgeMaintain extensive clinical/scientific expertise as a subject matter expert of the relevant therapeutic areas, products, company pipeline, medical technology and competitors.Maintain understanding of medical device development methodology, marketing and market access concepts, health care reimbursement to be able to collaborate with business partners. Scientific Communication Develop peer-level relationship networks with thought leaders, professional groups, organizations, decision makers and other key stakeholders in cardiovascular diseases in the assigned geography.Share and discuss evidence-based scientific data with stakeholders in accordance with company guidancePart of the Physicians team in the Medical Office to support the Clinical Support Center and Field Team in patient support cases, also responding to unsolicited questions as appropriate through ‘one on one’ contacts and group presentationsFacilitate education on disease state, product pipeline and competitor products to internal stakeholders and external customers as appropriate.Your ExpertiseMedical Degree with ideally 2–5 years of experience in the Medical Device IndustryProven understanding of the medical device and healthcare system requirementsAnalytical skills and capability to understand, interpret, and communicate complex scientific information Excellent verbal and written communication skills and fluency in English. Another European language is an advantageExcellent interpersonal skills, Ability to communicate effectively with Thought Leaders Strong team player and mature personality that works effectively on cross-functional teams, with medical and non-medical professionals at all levels and in an international environmentExcellent organizational and managerial skills with proven track record in the organization of medical-scientific eventsAbility to travel nationally and internationally approximately 80% of the timeLanguage proficiency in German & English Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sex, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.Über das Unternehmen:Johnson & Johnson Family of Companies

Abiomed is an innovative medical device business with an inspiring mission "Patients First," and a unique guiding company principle " Recovering hearts. Saving lives." With more than 2,000 employees, Abiomed is one of the fastest growing medical technology businesses in the world with corporate headquarters in Danvers, USA, and locations in Aachen and Berlin, Germany, Tokyo, Japan, and Singapore. Abiomed is part of Johnson & Johnson MedTech.Abiomed is an employer with attractive working conditions and an appreciative corporate culture that focuses on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development. Medical Science Liaison (d/f/m) Medical Device - Region Germany North-West This role reports to the Associate Director Medical Affairs EMEA. The Medical Science Liaison will manage the regional efforts of the Medical Affairs group within the European Medical Affairs Team. The Medical Science Liaison is responsible for supporting the EMEA Abiomed Business in establishing highest medical-scientific credibility with our customers. The Medical Science Liaison shall act as a scientific expert between Abiomed and the medical community through the communication of scientific evidence-based data and serves as an expert consultant to internal cross-functional partners within Abiomed by providing product related, evidence-based information, including educational support to the Sales and Marketing groups. This position is key to sharing and deepening the clinical understanding of cardiac unloading and heart recovery in the specialist community. Principle Duties & ResponsibilitiesServes as an expert resource on Abiomed’s product’s scientific and clinical evidence and associated disease states to the Company, specifically the Commercial Organization, implementing the company’s scientific communication strategy on a regional level through regular field visits and collaborationServes as an information source to physicians and researchers through dissemination, clarification and education of scientific clinical evidence. Responsible for external speaker approval and qualification using the most current scientific and clinical information including quality control. Medical Science & Therapeutic Area KnowledgeMaintain extensive clinical/scientific expertise as a subject matter expert of the relevant therapeutic areas, products, company pipeline, medical technology and competitors.Maintain understanding of medical device development methodology, marketing and market access concepts, health care reimbursement to be able to collaborate with business partners. Scientific Communication Develop peer-level relationship networks with thought leaders, professional groups, organizations, decision makers and other key stakeholders in cardiovascular diseases in the assigned geography.Share and discuss evidence-based scientific data with stakeholders in accordance with company guidancePart of the Physicians team in the Medical Office to support the Clinical Support Center and Field Team in patient support cases, also responding to unsolicited questions as appropriate through ‘one on one’ contacts and group presentationsFacilitate education on disease state, product pipeline and competitor products to internal stakeholders and external customers as appropriate.Your ExpertiseMedical Degree with ideally 2–5 years of experience in the Medical Device IndustryProven understanding of the medical device and healthcare system requirementsAnalytical skills and capability to understand, interpret, and communicate complex scientific information Excellent verbal and written communication skills and fluency in English. Another European language is an advantageExcellent interpersonal skills, Ability to communicate effectively with Thought Leaders Strong team player and mature personality that works effectively on cross-functional teams, with medical and non-medical professionals at all levels and in an international environmentExcellent organizational and managerial skills with proven track record in the organization of medical-scientific eventsAbility to travel nationally and internationally approximately 80% of the timeLanguage proficiency in German & English Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sex, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.Über das Unternehmen:Johnson & Johnson Family of Companies

Help us change livesAt Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.Company OverviewExact Sciences is dedicated to delivering patient critical answers across the cancer journey from early detection to treatment decision making. With a strong focus on people and an empathetic spirit, which fuels the company’s culture, driving them to create and deliver solutions rooted in the needs of patients, providers, and families. From earlier cancer detection to treatment guidance and monitoring, Exact Sciences are helping people get the answers they need to make more informed decisions across the cancer continuum. With a leading portfolio of products for earlier detection and treatment guidance, they help people face the most challenging decisions with confidence with a dedication to continuously innovate, combining scientific rigor with an open-minded approach to deliver the next big thing.Exact Sciences is continuously expanding the pipeline with the aim of tackling a wider array of cancer tests through the following measures:Expanding the Oncotype IQ platform to include liquid and tissue-based tests, all with the goal of making cancer care smarter.Adapting biomarker-based technologies create a liquid biopsy capable of detecting cancers and precancers from a blood sample.Using their proven multi-marker approach to achieve analytical sensitivity needed to discriminate between normal and cancerous samples.Collaborating with world-class clinicians and scientists at Mayo Clinic to identify biomarkers associated with the 15 deadliest cancers.Building a cancer detection platform upon learnings from the development of Cologuard (commercially available in the US only).By 2020, Oncotype DX will have been used to guide treatment decisions for more than 1 million cancer patients worldwide in breast, prostate and colon cancer.In July 2019 Exact Sciences acquired Genomic Health, a genetic cancer detection company based in Redwood City, California, for USD 2.8 billion, creating the leading global cancer diagnostics company.In 2020 Exact Sciences acquired Thrive Earlier Detection Corp., a Massachusetts-based healthcare company, in a multi-billion-dollar deal, and Base Genomics, which has technology for DNA methylation analysis.In February 2021 Exact Sciences announced the acquisition of Ashion Analytics, LLC (Ashion) from The Translational Genomics Research Institute (TGen), an affiliate of City of Hope. Ashion is a CLIA-certified and CAP-accredited sequencing lab based in Phoenix, Arizona with the genomics testing capabilities necessary to address the increasingly complex needs of clinical, academic, and biopharma customers focused on precision cancer treatments.The company is based in the United States, with International headquarters in Zug, Switzerland. Position SummaryThe Medical Affairs Senior Manager, MSL & Expansion Markets, France is a hybrid role responsible for leading an international team of Medical Science Liaisons and supporting Exact Sciences International expansion strategy with key medical activities.This is an exciting chance to build the first Exact Sciences International MSL team in leading and executing an efficient and transparent conversion plan to bring MSL contractors in-house as well as hire and onboard new MSLs to create a diverse and inclusive team. The International Medical Affairs Senior Manager – MSL & Expansion Markets will be expected to develop and drive MSL strategy ensure field medical activities and insight generation result in demonstrable outcomes and further develop and grow the MSL capability at Exact Sciences International.In addition, this individual will be responsible for medical affairs activities in selected key markets across International. These markets will include those where we want to move directly into a market (currently through distributors) or those markets where we currently have limited patient access that require improved reimbursement pathways.The Medical lead will work closely with the Market Expansion Team and lead all associated medial activities that may include leading medical activities for change in market reimbursement, aligning new market needs with central medical team, developing core data strategy for new markets, and defining resourcing needs and transition to new hires. The position is also responsible for consolidating and interpreting medical intelligence and reporting it to the Expansion Markets team.The incumbent will work closely with other functions within the company, including Corporate Strategy, Marketing, and Commercial to advance cross-functional understanding of the MSL value proposition, identify gaps and achieve results in line with company objectives.Representing the medical function, this individual will also manage research and educational medical objectives, while supporting commercial business and reimbursement objectives for the Oncotype DX breast recurrence score test.This position requires professionals with established personal and scientific creditability to interact with thought leaders, government health authorities, and medical centers of excellence. This is a dynamic role and will continue to evolve.Responsibilities/DutiesLead an international team of MSLs toward the implementation of field medical activities by communicating expectations and guiding the team to maintain and effectively communicate deep scientific knowledge and excel at KOL engagement and support medical/scientific information needs of scientific and clinical experts.Accompany the team to meetings with KOLs and other HCPs to assess proficiency and provide timely and constructive performance feedback.Lead and coordinate MSL team meetings to support team building, best practice sharing, development, and the accomplishment of field medical objectives.Develop a MSL Strategic Plan as well as Medical Plan for the markets, which include plans for KOL engagement, data generation, educational and guideline initiatives and reimbursement initiatives that align with the business objectives.Identify and engage international, national, and regional thought leaders in breast cancer within assigned geographic regions to conduct scientific discussions and understand insights related to molecular diagnostics in early BC management, while also establishing and maintaining professional relationships with them.Act as primary contact for investigators interested in developing and performing studies with the company’s commercially available assays in breast cancer.Assist in R&D and investigator-initiated studies as appropriate.Lead national and regional Advisory Boards when external advice is needed.Provide clinical presentations and information in academic, community, and healthcare provider setting in both group and one-on-one situations.Support & partner with regional team to deliver key medical activities.Developing medical slides, giving medical training presentations, and training in internal meetings and for partner distributors.Support international access & reimbursement with medical and scientific expertise.Assure compliance with relevant corporate policies.Provide feedback and medical input to local commercial plans and strategies.Pivotal Experience & ExpertiseDegree in Medicine/Medical Doctor or PhD, PharmD.3+ years of therapeutic clinical experience desired.5 to 7 years of industry experience (working in pharma/biotech/med tech).At least 3 years in a Medical Science Liaison role.Previous MSL (or other) management experience.Expertise in Oncology. Experience in breast/GI/lung cancer is a plus.Experience in Diagnostics or Biotech industry is a plus.Experience in relevant geographies a plus.Excellent English. Skills in other languages preferred.Excellent oral, written and presentation communication skills.Ability to independently deliver quality results in a timely manner.Proven record of working in matrix environment and delivering as part of a cross-functional team.Track record of delivering innovative medical activities across markets.Cultural ImpactHighest integrity and ethical behavior.Mutual respect for colleagues.Collaborative within teams, uses resources carefully and can build a great place to work and grow.Ability to interact within culturally diverse teams.Business acumen and innovative mindset. Ability to manage though complexity and ambiguity, while focusing on the end goal.OtherOffice-based in the International headquarters in Zug or out of one of our European offices.Ability to travel approx.. >50%.#LI-TK1Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, email E-Mail anzeigen. We’ll work with you to meet your accessibility needs.Not ready to apply? Join our talent community and stay up to date on what’s new at Exact Sciences. Standort PreventionGenetics, Munich

Help us change livesAt Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.Company OverviewExact Sciences is dedicated to delivering patient critical answers across the cancer journey from early detection to treatment decision making. With a strong focus on people and an empathetic spirit, which fuels the company’s culture, driving them to create and deliver solutions rooted in the needs of patients, providers, and families. From earlier cancer detection to treatment guidance and monitoring, Exact Sciences are helping people get the answers they need to make more informed decisions across the cancer continuum. With a leading portfolio of products for earlier detection and treatment guidance, they help people face the most challenging decisions with confidence with a dedication to continuously innovate, combining scientific rigor with an open-minded approach to deliver the next big thing.Exact Sciences is continuously expanding the pipeline with the aim of tackling a wider array of cancer tests through the following measures:Expanding the Oncotype IQ platform to include liquid and tissue-based tests, all with the goal of making cancer care smarter.Adapting biomarker-based technologies create a liquid biopsy capable of detecting cancers and precancers from a blood sample.Using their proven multi-marker approach to achieve analytical sensitivity needed to discriminate between normal and cancerous samples.Collaborating with world-class clinicians and scientists at Mayo Clinic to identify biomarkers associated with the 15 deadliest cancers.Building a cancer detection platform upon learnings from the development of Cologuard (commercially available in the US only).By 2020, Oncotype DX will have been used to guide treatment decisions for more than 1 million cancer patients worldwide in breast, prostate and colon cancer.In July 2019 Exact Sciences acquired Genomic Health, a genetic cancer detection company based in Redwood City, California, for USD 2.8 billion, creating the leading global cancer diagnostics company.In 2020 Exact Sciences acquired Thrive Earlier Detection Corp., a Massachusetts-based healthcare company, in a multi-billion-dollar deal, and Base Genomics, which has technology for DNA methylation analysis.In February 2021 Exact Sciences announced the acquisition of Ashion Analytics, LLC (Ashion) from The Translational Genomics Research Institute (TGen), an affiliate of City of Hope. Ashion is a CLIA-certified and CAP-accredited sequencing lab based in Phoenix, Arizona with the genomics testing capabilities necessary to address the increasingly complex needs of clinical, academic, and biopharma customers focused on precision cancer treatments.The company is based in the United States, with International headquarters in Zug, Switzerland. Position SummaryThe Medical Affairs Senior Manager, MSL & Expansion Markets, France is a hybrid role responsible for leading an international team of Medical Science Liaisons and supporting Exact Sciences International expansion strategy with key medical activities.This is an exciting chance to build the first Exact Sciences International MSL team in leading and executing an efficient and transparent conversion plan to bring MSL contractors in-house as well as hire and onboard new MSLs to create a diverse and inclusive team. The International Medical Affairs Senior Manager – MSL & Expansion Markets will be expected to develop and drive MSL strategy ensure field medical activities and insight generation result in demonstrable outcomes and further develop and grow the MSL capability at Exact Sciences International.In addition, this individual will be responsible for medical affairs activities in selected key markets across International. These markets will include those where we want to move directly into a market (currently through distributors) or those markets where we currently have limited patient access that require improved reimbursement pathways.The Medical lead will work closely with the Market Expansion Team and lead all associated medial activities that may include leading medical activities for change in market reimbursement, aligning new market needs with central medical team, developing core data strategy for new markets, and defining resourcing needs and transition to new hires. The position is also responsible for consolidating and interpreting medical intelligence and reporting it to the Expansion Markets team.The incumbent will work closely with other functions within the company, including Corporate Strategy, Marketing, and Commercial to advance cross-functional understanding of the MSL value proposition, identify gaps and achieve results in line with company objectives.Representing the medical function, this individual will also manage research and educational medical objectives, while supporting commercial business and reimbursement objectives for the Oncotype DX breast recurrence score test.This position requires professionals with established personal and scientific creditability to interact with thought leaders, government health authorities, and medical centers of excellence. This is a dynamic role and will continue to evolve.Responsibilities/DutiesLead an international team of MSLs toward the implementation of field medical activities by communicating expectations and guiding the team to maintain and effectively communicate deep scientific knowledge and excel at KOL engagement and support medical/scientific information needs of scientific and clinical experts.Accompany the team to meetings with KOLs and other HCPs to assess proficiency and provide timely and constructive performance feedback.Lead and coordinate MSL team meetings to support team building, best practice sharing, development, and the accomplishment of field medical objectives.Develop a MSL Strategic Plan as well as Medical Plan for the markets, which include plans for KOL engagement, data generation, educational and guideline initiatives and reimbursement initiatives that align with the business objectives.Identify and engage international, national, and regional thought leaders in breast cancer within assigned geographic regions to conduct scientific discussions and understand insights related to molecular diagnostics in early BC management, while also establishing and maintaining professional relationships with them.Act as primary contact for investigators interested in developing and performing studies with the company’s commercially available assays in breast cancer.Assist in R&D and investigator-initiated studies as appropriate.Lead national and regional Advisory Boards when external advice is needed.Provide clinical presentations and information in academic, community, and healthcare provider setting in both group and one-on-one situations.Support & partner with regional team to deliver key medical activities.Developing medical slides, giving medical training presentations, and training in internal meetings and for partner distributors.Support international access & reimbursement with medical and scientific expertise.Assure compliance with relevant corporate policies.Provide feedback and medical input to local commercial plans and strategies.Pivotal Experience & ExpertiseDegree in Medicine/Medical Doctor or PhD, PharmD.3+ years of therapeutic clinical experience desired.5 to 7 years of industry experience (working in pharma/biotech/med tech).At least 3 years in a Medical Science Liaison role.Previous MSL (or other) management experience.Expertise in Oncology. Experience in breast/GI/lung cancer is a plus.Experience in Diagnostics or Biotech industry is a plus.Experience in relevant geographies a plus.Excellent English. Skills in other languages preferred.Excellent oral, written and presentation communication skills.Ability to independently deliver quality results in a timely manner.Proven record of working in matrix environment and delivering as part of a cross-functional team.Track record of delivering innovative medical activities across markets.Cultural ImpactHighest integrity and ethical behavior.Mutual respect for colleagues.Collaborative within teams, uses resources carefully and can build a great place to work and grow.Ability to interact within culturally diverse teams.Business acumen and innovative mindset. Ability to manage though complexity and ambiguity, while focusing on the end goal.OtherOffice-based in the International headquarters in Zug or out of one of our European offices.Ability to travel approx.. >50%.#LI-TK1Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, email E-Mail anzeigen. We’ll work with you to meet your accessibility needs.Not ready to apply? Join our talent community and stay up to date on what’s new at Exact Sciences. Standort PreventionGenetics, Cologne

Help us change livesAt Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.Company OverviewExact Sciences is dedicated to delivering patient critical answers across the cancer journey from early detection to treatment decision making. With a strong focus on people and an empathetic spirit, which fuels the company’s culture, driving them to create and deliver solutions rooted in the needs of patients, providers, and families. From earlier cancer detection to treatment guidance and monitoring, Exact Sciences are helping people get the answers they need to make more informed decisions across the cancer continuum. With a leading portfolio of products for earlier detection and treatment guidance, they help people face the most challenging decisions with confidence with a dedication to continuously innovate, combining scientific rigor with an open-minded approach to deliver the next big thing.Exact Sciences is continuously expanding the pipeline with the aim of tackling a wider array of cancer tests through the following measures:Expanding the Oncotype IQ platform to include liquid and tissue-based tests, all with the goal of making cancer care smarter.Adapting biomarker-based technologies create a liquid biopsy capable of detecting cancers and precancers from a blood sample.Using their proven multi-marker approach to achieve analytical sensitivity needed to discriminate between normal and cancerous samples.Collaborating with world-class clinicians and scientists at Mayo Clinic to identify biomarkers associated with the 15 deadliest cancers.Building a cancer detection platform upon learnings from the development of Cologuard (commercially available in the US only).By 2020, Oncotype DX will have been used to guide treatment decisions for more than 1 million cancer patients worldwide in breast, prostate and colon cancer.In July 2019 Exact Sciences acquired Genomic Health, a genetic cancer detection company based in Redwood City, California, for USD 2.8 billion, creating the leading global cancer diagnostics company.In 2020 Exact Sciences acquired Thrive Earlier Detection Corp., a Massachusetts-based healthcare company, in a multi-billion-dollar deal, and Base Genomics, which has technology for DNA methylation analysis.In February 2021 Exact Sciences announced the acquisition of Ashion Analytics, LLC (Ashion) from The Translational Genomics Research Institute (TGen), an affiliate of City of Hope. Ashion is a CLIA-certified and CAP-accredited sequencing lab based in Phoenix, Arizona with the genomics testing capabilities necessary to address the increasingly complex needs of clinical, academic, and biopharma customers focused on precision cancer treatments.The company is based in the United States, with International headquarters in Zug, Switzerland. Position SummaryThe Medical Affairs Senior Manager, MSL & Expansion Markets, France is a hybrid role responsible for leading an international team of Medical Science Liaisons and supporting Exact Sciences International expansion strategy with key medical activities.This is an exciting chance to build the first Exact Sciences International MSL team in leading and executing an efficient and transparent conversion plan to bring MSL contractors in-house as well as hire and onboard new MSLs to create a diverse and inclusive team. The International Medical Affairs Senior Manager – MSL & Expansion Markets will be expected to develop and drive MSL strategy ensure field medical activities and insight generation result in demonstrable outcomes and further develop and grow the MSL capability at Exact Sciences International.In addition, this individual will be responsible for medical affairs activities in selected key markets across International. These markets will include those where we want to move directly into a market (currently through distributors) or those markets where we currently have limited patient access that require improved reimbursement pathways.The Medical lead will work closely with the Market Expansion Team and lead all associated medial activities that may include leading medical activities for change in market reimbursement, aligning new market needs with central medical team, developing core data strategy for new markets, and defining resourcing needs and transition to new hires. The position is also responsible for consolidating and interpreting medical intelligence and reporting it to the Expansion Markets team.The incumbent will work closely with other functions within the company, including Corporate Strategy, Marketing, and Commercial to advance cross-functional understanding of the MSL value proposition, identify gaps and achieve results in line with company objectives.Representing the medical function, this individual will also manage research and educational medical objectives, while supporting commercial business and reimbursement objectives for the Oncotype DX breast recurrence score test.This position requires professionals with established personal and scientific creditability to interact with thought leaders, government health authorities, and medical centers of excellence. This is a dynamic role and will continue to evolve.Responsibilities/DutiesLead an international team of MSLs toward the implementation of field medical activities by communicating expectations and guiding the team to maintain and effectively communicate deep scientific knowledge and excel at KOL engagement and support medical/scientific information needs of scientific and clinical experts.Accompany the team to meetings with KOLs and other HCPs to assess proficiency and provide timely and constructive performance feedback.Lead and coordinate MSL team meetings to support team building, best practice sharing, development, and the accomplishment of field medical objectives.Develop a MSL Strategic Plan as well as Medical Plan for the markets, which include plans for KOL engagement, data generation, educational and guideline initiatives and reimbursement initiatives that align with the business objectives.Identify and engage international, national, and regional thought leaders in breast cancer within assigned geographic regions to conduct scientific discussions and understand insights related to molecular diagnostics in early BC management, while also establishing and maintaining professional relationships with them.Act as primary contact for investigators interested in developing and performing studies with the company’s commercially available assays in breast cancer.Assist in R&D and investigator-initiated studies as appropriate.Lead national and regional Advisory Boards when external advice is needed.Provide clinical presentations and information in academic, community, and healthcare provider setting in both group and one-on-one situations.Support & partner with regional team to deliver key medical activities.Developing medical slides, giving medical training presentations, and training in internal meetings and for partner distributors.Support international access & reimbursement with medical and scientific expertise.Assure compliance with relevant corporate policies.Provide feedback and medical input to local commercial plans and strategies.Pivotal Experience & ExpertiseDegree in Medicine/Medical Doctor or PhD, PharmD.3+ years of therapeutic clinical experience desired.5 to 7 years of industry experience (working in pharma/biotech/med tech).At least 3 years in a Medical Science Liaison role.Previous MSL (or other) management experience.Expertise in Oncology. Experience in breast/GI/lung cancer is a plus.Experience in Diagnostics or Biotech industry is a plus.Experience in relevant geographies a plus.Excellent English. Skills in other languages preferred.Excellent oral, written and presentation communication skills.Ability to independently deliver quality results in a timely manner.Proven record of working in matrix environment and delivering as part of a cross-functional team.Track record of delivering innovative medical activities across markets.Cultural ImpactHighest integrity and ethical behavior.Mutual respect for colleagues.Collaborative within teams, uses resources carefully and can build a great place to work and grow.Ability to interact within culturally diverse teams.Business acumen and innovative mindset. Ability to manage though complexity and ambiguity, while focusing on the end goal.OtherOffice-based in the International headquarters in Zug or out of one of our European offices.Ability to travel approx.. >50%.#LI-TK1Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, email E-Mail anzeigen. We’ll work with you to meet your accessibility needs.Not ready to apply? Join our talent community and stay up to date on what’s new at Exact Sciences. Standort PreventionGenetics, Düsseldorf