Überblick über die Statistik des Gehaltsniveaus für "Human Resources Director Operations in Deutschland"

Location: Poland - Home based        Schedule: Freelance, Various FTEs                                    CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Freelance Clinical Project Manager I, to join their clinical operations team in Poland. This is a full-time opportunity. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                      As a Project Manager, you will be responsible, for oversight of assigned clinical projects ensuring the quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines, and other, applicable regulations. You may also act as Project Director/Leader, depending on the complexity of the projects.   Join our team and help us deliver clinical trials that will improve patients' lives.                   Main Tasks and Responsibilities:Manages the development and planning of clinical projects, interacting with the Sponsor and the Investigators and coordinating the project team memberOversees the application process for clinical studies, in force in the country(ies) of work. Verifies the assigned project activities plan and timelines and the related critical stateManages the budget of the projectParticipates in Monitor's and Investigator's MeetingsProvides project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director; participates in update meetings.Informs Project Director/Leader and the Clinical Department Director about any issues that can jeopardize the business relationship with the SponsorSupervises the team in relation to monitoring including submissions, site visits, ensuring compliance with ICH/GCP guidelines and applicable laws and regulationsUndertakes workload and performance assessments of the project team working with the Clinical Research Department Director to ensure adequate support levelsMay provide oversight and mentoring for junior staff assigned to the projects.Supervises the archiving activitiesSupervises, in the overall management of the project, the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc…)Assists the Medical Monitor (MEM) in preparing protocols, Case Report Forms (CRFs), and final Clinical Study Reports (CSRs)Performs, if necessary, co-monitoring visits for the assigned clinical projectsMay act as Feasibility Associate (FEA) after appropriate and documented trainingMay prepare SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU)Arranges and collaborate with the assigned Clinical Research Department Director, in identifying the project-specific training of the project team and in delivering them Education and Experience:University Degree in scientific, medical, or paramedical disciplinesUp to three 3 years of project management experience in the CRO/Pharmaceutical industryStrong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel The Application Process   Once 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 @ http://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 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. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage 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: Senior Project Manager, Clinical Project Manager, Senior Study Manager, Study Management Associate, Project Management Associate, Clinical, Drugs, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, CRO, Clinical Research Organisation, Contract Research Organisation  Skills: Clinical Project Manager, Clinical Study Manager, clinical trials, ICH-GCP, Project Management, EnglishLocation: PolandShare: LinkedIn Facebook Twitter Email

Das Unternehmen:Die TD Deutsche Klimakompressor GmbH ist ein Tochterunternehmen von Toyota Industries und Denso. Unser Unternehmen fertigt Klimakompressoren mit stufenloser Leistungsregelung für die Automobilindustrie in Großserie. Am Standort Kamenz bei Dresden bieten wir unseren etwa 950 Mitarbeitern ein attraktives Arbeitsumfeld. Wir suchen zum nächstmöglichen Zeitpunkt eine/n Unser Angebot:Gelegenheit zum Sammeln von Erfahrungen im Personalwesen mit interkulturellem Arbeitsumfeldspannende und abwechslungsreiche Tätigkeitenein freundliches, motiviertes und unterstützendes Teamgefügemodernes Zeiterfassungssystem sowie Flexibilität in der Arbeitszeit im Rahmen der betrieblichen Möglichkeitensubventionierte KantinenversorgungIhre zukünftigen Aufgaben:Unterstützung unserer Personalreferenten bei der operativen Betreuung von Mitarbeiter*innen und Führungskräften sowie bei PersonalentwicklungsthemenBegleitung von regelmäßigen internen Prozessen wie der Mitarbeiterbeurteilung und -befragungUnterstützung bei Recherchen und Konzepterstellung zu verschiedenen ProjektthemenDas zeichnet Sie aus:Studium im Bereich Wirtschaftswissenschaften / Psychologie oder einem vergleichbaren Studiengang mit Schwerpunkt Personalidealerweise erste praktische Erfahrungen im Personalbereich durch Praktika oder Nebenjobsfundierte MS-Office-Kenntnissegute Englischkenntnisse in Wort und Schriftoffene, kommunikative Art und Spaß an der Arbeit in einem TeamBitte senden Sie Ihre Bewerbung unter Angabe Ihres frühestmöglichen Eintrittstermins als E-Mail in einer PDF-Datei an [email protected]. Gern steht Ihnen Frau Dutschmann bei Rückfragen unter der Rufnummer 035 723/ 94-375 zur Verfügung.

Location: United States - Fort Washington, PA, or Cary NC  Schedule: Full-time, Permanent     ClinChoice, the parent company of CROMSOURCE, is a leading full-service clinical CRO dedicated to offering high-quality one-stop services to pharmaceutical, biotechnology, medical device, and consumer products clients, who are dedicated to the professional development of our employees and providing an excellent work-life balance. We are looking for a dynamic person to join our in-house team as an Executive Director of Human Resources in the United States. This role will be office based in either Fort Washington, PA or Cary, NC with flexibility to work from home two days per week. Previous experience with a CRO is required.        The Executive Director of Human Resources will manage day-to-day HR operations in North America and provide strategic leadership and direction to the HR department. This position will be involved in every aspect of Human Resources function in North America including but not limited to organizational HR policy and compliance, talent management, employee relations, performance and benefit reviews, compensation, and other duties as assigned. Additionally, the position will work with the Global Head of HR and other HR Regional Heads to set strategy and ensure standardization and collaboration across the international organization of ClinChoice.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities:Lead and oversee day-to-day activities for HR functions in North America, including but not limited to HR system evaluation and implementation, HR core functions such as performance review and compensation, benefit, training requirements, terminations, onboarding and offboarding, etc.Lead the development and implementation of HR procedures and policies, and ensure the policies are in compliance with their respective country and local labor laws including health and safety, equal employment opportunity, diversity and inclusion, compensation and benefit requirements, pension plans, taxes, privacy, and any other laws.Team up with the recruitment group to develop cost-effective recruitment strategies and long-term talent acquisition plans to support the company's overall goal and look for creative solutions to meet fast-growing resource needs.Collaborate with other regional HR leads for alignment of the strategies and processes across the international organizations.Collaborate with and support the functional management team to ensure satisfactory employee retention.Prepare and present regularly or as needed to the International HR management team and update North America regional HR and initiatives. Support and contribute to the HR dashboard as needed. Education and Experience:A bachelor's degree in human resources or other fields is required. An MBA or master's degree in human resources or business is preferred.Thorough knowledge of North American (USA and Canada, particularly) employment-related laws and regulations.Experience with human resource information systems.10+ years of experience in Human Resources.  3+ years of leadership roles and team management in Human Resources in North America.Experience in HR management systems, such as ADP, SAP, or other systems.Experience working in a fast-paced, collaborative team environment. Able to work efficiently under pressure and consistently meet tight deadlines.Experience working for a CRO is required. Specific Role Requirements and Skills:Ability to be discreet and handle confidential, sensitive information.Excellent verbal and written communication skills, including presentation skills.Excellent interpersonal and conflict resolution skills.Excellent organizational skills and attention to detail.Strong analytical and problem-solving skills.Strong supervisory and leadership skills.Excellent in Microsoft Word, Excel, PowerPoint, Outlook. The Application Process  Once 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 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 are 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: Executive Director of Human Resources, HR Director, HR Manager, Human Resources, Human Resources Director, Human Resources Manager, Compliance, Employee relations management, Recruiting, Retention strategy, HR management, Employment law, Onboarding Management, ADP, SAP, Human Resource Information Systems, HRISSkills: HR Manager, Clinical Research Organisation, CROLocation: United StatesShare: 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: Italy - Home or office based      Schedule: Permanent, Full-time                 Do you want to join a team that is passionate about making a difference in drug and medical device development?  CROMSOURCE, a growing CRO, is recruiting for a Senior Clinical Project Manager to join their clinical operations team. This is a permanent opportunity in Italy. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                          As a Senior Clinical Project Manager, you will be responsible, for oversight of assigned clinical projects ensuring the quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines, and other, applicable regulations. You may also act as Project Director/Leader, depending on the complexity of the projects. Previous experience with respiratory and oncology trials is preferred. A minimum of 3 years of experience with a CRO is needed.           Join our team and help us deliver clinical trials that will improve patients' lives.                               Main Tasks and Responsibilities:Manages the development and planning of clinical projects, interacting with the Sponsor and the Investigators, and coordinating the project team members.Oversees the application process for clinical studies, in force in the country(ies) of work. Verifies the assigned project activities plan and timelines and the related critical state.Manages the budget of the project.Participates in Monitor's and Investigator's MeetingsProvides project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director; participates in update meetings.Informs Project Director/Leader and the Clinical Department Director about any issues that can jeopardize the business relationship with the Sponsor.Supervises the team in relation to monitoring including submissions, site visits, ensuring compliance with ICH/GCP guidelines and applicable laws and regulations.Undertakes workload and performance assessments of the project team working with the Clinical Research Department Director to ensure adequate support levels.May provide oversight and mentoring for junior staff assigned to the projects.Supervises the archiving activities.Supervises, in the overall management of the project, the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc…)Assists the Medical Monitor (MEM) in preparing protocols, Case Report Forms (CRFs), and final Clinical Study Reports (CSRs)Performs, if necessary, co-monitoring visits for the assigned clinical projects.May act as Feasibility Associate (FEA) after appropriate and documented training.May prepare SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU)Arranges and collaborate with the assigned Clinical Research Department Director, in identifying the project-specific training of the project team and in delivering them. Education and Experience Required:University Degree in scientific, medical, or paramedical disciplines with 3 years of experienceSignificant 3 years of experience in clinical project management in the CRO/pharmaceutical industryExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel. The Benefits of Working in Italy:· Meal vouchers· Mobile phone if requested by the Line Manager· Dedicated Line Manager 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 can 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.                                     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 @ http://www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.                                        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: Project Manager, Clinical Project Manager, CRO, Clinical Research Organisation, Contract Research Organisation, Clinical, Drugs, Medical Devices, Medical Device, Project Management, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, Respiratory, Oncology, OphthalmologySkills: Clinical Project Manager, Clinical Study Manager, Clinical Trial Manager, Senior Clinical Project Manager, clinical trials, CRO, Medical Devices, Study ManagementLocation: ItalyShare: LinkedIn Facebook Twitter Email

Location: Germany- Home or office based      Schedule: Permanent, Full-time                 Do you want to join a team that is passionate about making a difference in drug and medical device development? CROMSOURCE, a growing CRO, is recruiting for a Senior Clinical Project Manager to join their clinical operations team. This is a permanent opportunity in Germany. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                          As a Senior Clinical Project Manager, you will be responsible, for oversight of assigned clinical projects ensuring the quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines, and other, applicable regulations. You may also act as Project Director/Leader, depending on the complexity of the projects. Previous experience with respiratory and oncology trials is preferred. A minimum of 3 years of experience with a CRO is needed.           Join our team and help us deliver clinical trials that will improve patients' lives.                                 Main Tasks and Responsibilities:Manages the development and planning of clinical projects, interacting with the Sponsor and the Investigators, and coordinating the project team members.Oversees the application process for clinical studies, in force in the country(ies) of work. Verifies the assigned project activities plan and timelines and the related critical state.Manages the budget of the project.Participates in Monitor's and Investigator's MeetingsProvides project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director; participates in update meetings.Informs Project Director/Leader and the Clinical Department Director about any issues that can jeopardize the business relationship with the Sponsor.Supervises the team in relation to monitoring including submissions, site visits, ensuring compliance with ICH/GCP guidelines and applicable laws and regulations.Undertakes workload and performance assessments of the project team working with the Clinical Research Department Director to ensure adequate support levels.May provide oversight and mentoring for junior staff assigned to the projects.Supervises the archiving activities.Supervises, in the overall management of the project, the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc…)Assists the Medical Monitor (MEM) in preparing protocols, Case Report Forms (CRFs), and final Clinical Study Reports (CSRs)Performs, if necessary, co-monitoring visits for the assigned clinical projects.May act as Feasibility Associate (FEA) after appropriate and documented training.May prepare SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU)Arranges and collaborate with the assigned Clinical Research Department Director, in identifying the project-specific training of the project team and in delivering them. Education and Experience Required:University Degree in scientific, medical, or paramedical disciplines with 3 years of experienceSignificant 3 years of experience in clinical project management in the CRO/pharmaceutical industryExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel. The Benefits of Working in Germany:30 Euro net Internet cost reimbursement per monthAdditional Accident Insurance, fully covered by the company.25 vacation daysPossibility of salary conversion for additional pension insuranceDedicated Line ManagerMonthly meetings with the line managerFull performance and development process with end-of-year reviewsTeam events and end-of-year partyCareer opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationallyEmployee satisfaction survey - your feedback is important for continuous improvement. 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 can 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.                                     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 @ http://www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.                                          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: Project Manager, Clinical Project Manager, CRO, Clinical Research Organisation, Contract Research Organisation, Clinical, Drugs, Medical Devices, Medical Device, Project Management, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, Respiratory, Oncology, OphthalmologySkills: Clinical Project Manager, Clinical Trial Manager, clinical trials, CRO, Medical Devices, Project Leadership, Project ManagementLocation: GermanyShare: LinkedIn Facebook Twitter Email

Pilot Plant Manager Location: Lubeck, Germany Team: Technical As Pilot Plant Manager, you will be the lead for the Pilot Plant in Luebeck, our Customer Innovation & Collaboration Center (CI&CC), including facility, driving the pilot and facility team, managing the machines and equipment for actual and future needs to collaborate efficiently with our customers. You will network with our technical community to get our CI&CC set for the present and future challenges. You are ensuring that the building's technical installations, safety technology, machines and equipment function properly, taking into account and complying with the legal and technical requirements, as well as the requirements of Tate & Lyle. You will manage and plan the deployment of employees in the facility and technical center area (approx. 10 employees) as well as process and cost optimization. Tasks & responsibilities Operations management Manage health, safety, food safety, hygiene and environmental conditions at pilot level and facility level; work closely with the Safety officer Plans the overall allocation of human and material resources, as well as production’s agenda and general organizational procedures Makes investment propositions Ensuring that the Quality culture and compliance with Quality procedures are integrated Ensure the maintenance and availability of equipment. Implementing a continuous improvement approach to improve processes, people development and equipment. Strategy Connect and work transversally with technical leads (Technical Service and Application), in terms of planning efficiently short/medium/long term activities of the teams, and transformation needs of the premise to fulfill the strategies Facility Management Ensure building’s technical installation, safety technology run and comply with the legal and technical requirements incl. document management, as well as the requirements of Tate & Lyle. Manage of the service contractors, 3rd party vendors and long-term leasers and agreed contracts with the support of the Global purchaser team and on-site facility team Responsible for relations and contracts with tenants In charge of fire safety on site with vendors support, relation with fire brigade and insurer Ensure all works carried out are completed in a safe and controlled manner adhering with legislation Finance Work closely with the Technical Service Director Europe, and others key stakeholders to ensure accurate forecasting, close management and controlling of the budgets (Monthly - Quarterly and Annually) Ensure budgets for works are closely managed and each project is delivered in line with the assigned project and time scales Project Management - Policy Implementation & EHSQS Journey Review Operational procedures, ensure the teams are working efficiently, complying with our EHSQS standards (using our internal audits system); provide continuous feedback on best practice and safe working systems Where required support with the creation and roll out of new initiatives and projects to optimize process and costs, maintain/improve standards and safety requirements Ensure the food safety and the legal compliance is being achieved with EHSQS team support Take a proactive approach towards your own team and your own continuous development in line with legislation and operational best practice. Work closely with your direct reports to ensure our values are alive and kicking Qualifications Have an Engineering or Technical (Food Production / Food Safety) diploma. Experience managing and understanding of Safety legislation and Food Safety Have experience of managing team Experience managing outsourced contractors Preventative Maintenance Safety compliance (fire alarms, water hygiene, lifts, fire extinguishers, F&B etc.). Fluent in German & English Networking, communication, organization and project management skills It would be preferred if you have certificates for a qualified electrician and fire safety officer What we can offer you A competitive salary Bonus opportunity Unlimited Contract Holiday pay and 13th salary 40 € per month for a private pension plan 30 days annual leave Flexible working hours Job bike / company fitness On-site canteen and free water, coffee, tea without end, as well as muesli and milk Good free parking facilities Are you interested? Then we look forward to receiving your application on our careers page. Tate & Lyle is an equal opportunity employer, committed to the strength of an inclusive workforce. Our purpose, Improving Lives for Generations, inspires everything we do. Whether it’s by making food and drink healthier and tastier; continuously improving how we work; promoting a safe working environment; or making a difference to our local communities, we believe we can successfully grow our business and have a positive impact on society. Our work is driven by consumer health needs and trends, governments desire to build and support healthy communities, and the need for affordable food and nutrition in many parts of the world. We deliver ingredients and solutions to meet all these needs. Our speciality sweeteners and fibres help reduce sugar and calories. Our fibres enrich food and improve digestive health. Our texturants and stabilising systems help extend shelf-life and make food manufacturing easier. Our bulk sweeteners deliver great tasting products at an affordable cost. And our industrial starches give strength to the packaging used to deliver online goods to millions of homes every day. Across the globe, we are Improving Lives for Generations. And all our talented and skilled people help us on this journey. Want to know more? Take a look here.Über das Unternehmen:5116 G. C. Hahn & Co. Stabilisierungstechnik GmbH

Über das UnternehmenSeit über 60 Jahren sind wir der gute Name in der holzbe- und verarbeitenden Industrie. Wir sind ein international tätiger Hersteller von Maschinen und Fertigungsstraßen für die Möbel- und Bauelementeindustrie sowie Anbieter produktbegleitender Dienstleistungen.Seit 1951 entwickeln wir mit unseren Kompetenzen in den Bereichen Stationär-, Durchlauf-, Verfahrenstechnik und Transport/Handling maßgeschneiderte Kundenlösungen. Wir stehen als Lösungsanbieter für ein kundenorientiertes Konzept: von der ersten Geschäftsidee, über die Realisierung, bis hin zu kontinuierlicher Optimierung des gesamten Produktionsprozesses begleiten wir unsere Auftraggeber. Möglich wird dies durch hochqualifizierte, motivierte Mitarbeiterinnen und Mitarbeiter mit langjährigem Know-how und stetiger Aus- und Weiterbildung. Wir beschäftigen in neun Tochtergesellschaften in Europa, Amerika und Asien über 900 Mitarbeiter. Wir sind mit mehr als 60 Handelspartnern weltweit in über 60 Ländern vertreten. Mit Hauptsitz in Lübbecke/Westfalen, Deutschland, bieten wir Produktlösungen von der Hochleistungs- über Stückzahl-1-Fertigung bis hin zu komplexen Verfahrenstechnologien wie dem Laser Edging, inklusive zugehöriger Softwarelösungen. Unter anderem zählen viele namhafte Möbel- und Küchenhersteller zu unseren Kunden.Was bieten wir dir? Bei uns übernimmst du bereits nach kurzer Einarbeitung anspruchsvolle Aufgaben in deinem Einsatzgebiet Wir sind ein mittelständisches Unternehmen mit flachen Hierarchien, einer Duz-Kultur und kurzen Entscheidungswegen Bei uns herrscht ein sehr gutes Betriebsklima innerhalb der Abteilung und wir integrieren dich direkt als vollwertiges Teammitglied Du erhältst spannende Einblicke in die Arbeiten einer modernen Personalabteilung Wir bieten eine attraktive Praktikumsvergütung und den vollen Zugriff auf die Sonderkonditionen für unsere Mitarbeiter:innen bei Corporate BenefitsWas erwartet dich? Du wirst das Team direkt mit unterstützen, in dem du kleinere Projekte oder Aufgaben übernimmst Du befasst dich mit Aufgaben der Personalbetreuung und des Personalmarketings Du kümmerst dich um die Anfertigung von Verträgen und Zeugnissen Du unterstützt bei Recruiting-Veranstaltungen und der Ausgestaltung von Text- und Mediencontent Du steuerst unsere Social-Media-KanäleWas solltest du mitbringen? Du befindest dich in einem laufendem Bachelor- oder Masterstudium im Bereich Betriebswirtschaftslehre oder einer ähnlichen Fachrichtung Du hast Interesse an einem breiten und generalistischen Überblick im HR Du interessierst dich für die Arbeit in einem Team und bringst dich gerne ein Du verfügst über fließende Deutschkenntnisse in Wort und SchriftUnser Jobangebot Praktikum Human Resources (m/w/d)klingt vielversprechend?Bei unserem Partner Workwise ist eine Bewerbung für diesen Job in nur wenigen Minuten und ohne Anschreiben möglich. Anschließend kann der Status der Bewerbung live verfolgt werden. Wir freuen wir uns auf eine Bewerbung über Workwise. Standort IMA Schelling Deutschland GmbH, Lübbecke

Über das UnternehmenSoly Deutschland ist eine 100%ige Tochtergesellschaft des niederländischen Photovoltaikanbieters Soly.nl, der 2013 mit dem Ziel gegründet wurde, Photovoltaik für alle zugänglich zu machen. Aufgrund unseres immensen Wachstums ist es uns gelungen, mit inzwischen über 100 Mitarbeitern unsere PV Anlagen auf über 22.000 Dächern zu installieren. Seit Ende 2019 sind wir in Südafrika, seit 2022 zudem auf dem belgischen Markt und seit Anfang 2023 auch in Deutschland aktiv. Unser Unternehmen ist einer der führenden Photovoltaik-Anbieter in Europa und wird von Shell und dem Pensionsfonds ABP unterstützt.Was bieten wir Dir? Ein Praktikum, indem Du nicht nur Lernen und Dich weiterentwickeln kannst, sondern auch wertvolle Praxiseinblicke gewinnst Weiterentwicklungs- und Aufstiegsmöglichkeiten in einem wachsenden und zukunftsorientierten Unternehmen 30 Urlaubstage (bei einer 5 Tage Woche) und ein hybrides Home-Office-Modell Kostenfreie Parkmöglichkeiten, Snacks sowie Getränke und regelmäßige Firmenevents Vergünstigungen bei Kooperationspartnern und die Möglichkeit, Solarmodule zum Sonderpreis für Dein eigenes Zuhause zu mieten/kaufen 16 bezahlte Stunden im Jahr, an denen Du dich für gemeinnützige Arbeit einsetzen kannstWas erwartet Dich? Du begleitest verschiedene HR Prozesse wie z.B. das Recruiting (inkl. des Active Sourcings), das On- und Offboarding von Mitarbeitenden Du arbeitest an Projektaufgaben in den Themenbereichen Personalbeschaffung, Employer Branding oder Personalentwicklung Du bist verantwortlich für die Pflege der Personalakte und kümmerst dich um das Dokumentenmanagement wie z.B. die Erstellung von Arbeitsverträgen, Zeugnissen, Bescheinigungen etc. Du bist für die Sichtung sowie die Bewertung von Bewerbungsunterlagen zuständig und führst erste telefonische Interviews durch Du organisierst Teamevents um das Wohlbefinden sowie das Gemeinschaftsgefühl zu steigernWas solltest Du mitbringen? Du bist mindestens im dritten Semester an einer deutschen Hochschule immatrikuliert und hast großes Interesse am Personalwesen Du sucht ein Pflichtpraktikum oder ein freiwilliges Praktikum Du hast bereits erste Einblicke in Personalbereich durch Nebenjobs / Praktika sammeln können oder bringst eine Menge Motivation und Hunger auf neues HR- Wissen mit Du bist ein Teamplayer, arbeitest dennoch gern selbstständig und hast Interesse proaktiv Prozesse zu verbessern Du liebst es mit Menschen in Kontakt zu treten, dein Netzwerk auszubauen und lernst gern neues dazu Es fehlt dir nicht an Empathie, Freundlichkeit und DiskretionUnser Jobangebot Praktikum im Bereich Human Resources (m/w/d)klingt vielversprechend?Bei unserem Partner Workwise ist eine Bewerbung für diesen Job in nur wenigen Minuten und ohne Anschreiben möglich. Anschließend kann der Status der Bewerbung live verfolgt werden. Wir freuen wir uns auf eine Bewerbung über Workwise. Standort Soly Germany Operations GmbH, Düsseldorf

Über das UnternehmenSeit über 60 Jahren sind wir der gute Name in der holzbe- und verarbeitenden Industrie. Wir sind ein international tätiger Hersteller von Maschinen und Fertigungsstraßen für die Möbel- und Bauelementeindustrie sowie Anbieter produktbegleitender Dienstleistungen.Seit 1951 entwickeln wir mit unseren Kompetenzen in den Bereichen Stationär-, Durchlauf-, Verfahrenstechnik und Transport/Handling maßgeschneiderte Kundenlösungen. Wir stehen als Lösungsanbieter für ein kundenorientiertes Konzept: von der ersten Geschäftsidee, über die Realisierung, bis hin zu kontinuierlicher Optimierung des gesamten Produktionsprozesses begleiten wir unsere Auftraggeber. Möglich wird dies durch hochqualifizierte, motivierte Mitarbeiterinnen und Mitarbeiter mit langjährigem Know-how und stetiger Aus- und Weiterbildung. Wir beschäftigen in neun Tochtergesellschaften in Europa, Amerika und Asien über 900 Mitarbeiter. Wir sind mit mehr als 60 Handelspartnern weltweit in über 60 Ländern vertreten. Mit Hauptsitz in Lübbecke/Westfalen, Deutschland, bieten wir Produktlösungen von der Hochleistungs- über Stückzahl-1-Fertigung bis hin zu komplexen Verfahrenstechnologien wie dem Laser Edging, inklusive zugehöriger Softwarelösungen. Unter anderem zählen viele namhafte Möbel- und Küchenhersteller zu unseren Kunden.Was bieten wir dir? Bei uns übernimmst du bereits nach kurzer Einarbeitung anspruchsvolle Aufgaben in deinem Einsatzgebiet Wir sind ein mittelständisches Unternehmen mit flachen Hierarchien, einer Duz-Kultur und kurzen Entscheidungswegen Bei uns herrscht ein sehr gutes Betriebsklima innerhalb der Abteilung und wir integrieren dich direkt als vollwertiges Teammitglied Du erhältst spannende Einblicke in die Arbeiten einer modernen Personalabteilung Wir bieten eine attraktive Praktikumsvergütung und den vollen Zugriff auf die Sonderkonditionen für unsere Mitarbeiter:innen bei Corporate BenefitsWas erwartet dich? Du wirst das Team direkt mit unterstützen, in dem du kleinere Projekte oder Aufgaben übernimmst Du befasst dich mit Aufgaben der Personalbetreuung und des Personalmarketings Du kümmerst dich um die Anfertigung von Verträgen und Zeugnissen Du unterstützt bei Recruiting-Veranstaltungen und der Ausgestaltung von Text- und Mediencontent Du steuerst unsere Social-Media-KanäleWas solltest du mitbringen? Du befindest dich in einem laufendem Bachelor- oder Masterstudium im Bereich Betriebswirtschaftslehre oder einer ähnlichen Fachrichtung Du hast Interesse an einem breiten und generalistischen Überblick im HR Du interessierst dich für die Arbeit in einem Team und bringst dich gerne ein Du verfügst über fließende Deutschkenntnisse in Wort und SchriftUnser Jobangebot Praktikum für Recruiting im Human Resources Umfeld (m/w/d)klingt vielversprechend?Bei unserem Partner Workwise ist eine Bewerbung für diesen Job in nur wenigen Minuten und ohne Anschreiben möglich. Anschließend kann der Status der Bewerbung live verfolgt werden. Wir freuen wir uns auf eine Bewerbung über Workwise. Standort IMA Schelling Deutschland GmbH, Lübbecke

Location: United Kingdom - Hybrid (2 days in office)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, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations. The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, 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]@cromsource.com 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: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, Submissions.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: United KingdomShare: LinkedIn Facebook Twitter Email

Location: Belgium - Hybrid (2 days in office)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, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations.     The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities:Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process  Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, 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]@cromsource.com 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: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, Submissions.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: BelgiumShare: LinkedIn Facebook Twitter Email

Location: Italy - Hybrid (2 days in office)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, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations. The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, 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]@cromsource.com 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: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, SubmissionsSkills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: ItalyShare: LinkedIn Facebook Twitter Email

Location: Spain - Hybrid (2 days in office)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, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations. The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, 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]@cromsource.com 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: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, Submissions.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: SpainShare: LinkedIn Facebook Twitter Email

Location: Netherlands - Hybrid (2 days in office)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, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations.     The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities:Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process  Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, 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]@cromsource.com 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: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, Submissions.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: NetherlandsShare: LinkedIn Facebook Twitter Email