Überblick über die Statistik des Gehaltsniveaus für "Regulatory Management Consultant in Deutschland"

Location: Europe - home based    Schedule: Full-time, contract       Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds….         TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for Freelance Programmers  to join a global pharmaceutical company.         CROMSOURCE is an international CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with their client counterparts.           The Principal Statistical Programmer Analyst/Consultant is accountable for the quality, timely, and efficient delivery of projects, programming work, and good information management. This position requires profound programming experience and excellent industry knowledge to independently lead the implementation of programming activities as well as lead other programmers. It is a leadership role that can have a project or technical focus. It will provide subject matter expertise within the programming discipline as an expert within their own field, acts as a specialist within cross-functional teams to deliver continuous improvement. Must have experience working with oncology trials.         Main Job Tasks and Responsibilities:Leads and directs the full scope of project delivery and/or leads a technical project within the TA/Drug Project/study/function.Leads Implementation of statistical programming aspects of the protocol or clinical development program.Responsible for the high quality of all project deliverables, holding partners and providers accountable for the quality of their deliverable and/or technical subject matter expert for aspect(s) of the TA, Project, or function Leads or contribute to cross-functional administrative or process improvement initiative(s)Drives the development of best practices to improve quality, efficiency, and/or effectiveness within the function. Drives standards development and implementation.Manages and escalates risk in complicated or novel situations within their study and/or projects.Provides Programming expertise to the team.Provides tactical input and/or drives ideas and improvements.Contributes to the function by supporting recruiting and/or providing training and mentorship.Identifies opportunities to improve methodology and provides practical solutions for problems.Influences stakeholders by providing subject matter expertise on programming-related items.Ensures compliance with standards and automation usage.Employs all project management practices in managing drug or technical projects.Provides input to capacity management for all projects in scope.Maintains expertise in the latest industry and regulatory requirements to stay current. Education and Experience:Bachelor's degree in computer science (CS), statistics, or related scientific disciplines with 8 years of clinical programming experience; Master's degree in CS, statistics, or related disciplines with 7 years of clinical programming experience.Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology.Good understanding of the clinical drug development process.Detail oriented.Strong communication skills and coordination skills.Can communicate with global teams independently.Experience with oncology trials.  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 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 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.         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 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: Principal Statistical Programmer Analyst/Consultant, Consultant, Oncology, Respiratory, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, SAS programming, data analytics, statistics, statistical analysis, clinical trials, SQL, Microsoft Excel, Macros, HTML, ODS, operational data store, programming        Skills: Oncology, Data Analyst, SAS Programmer, clinical trials, CRO, Data Analysis, Outsourcing, SAS, SQL, statistical analysis, StatisticsLocation: EuropeShare: LinkedIn Facebook Twitter Email

Job Description About CapgeminiCapgemini is a global leader in consulting, digital transformation, technology and engineering services. The Group is at the forefront of innovation to address the entire breadth of clients’ opportunities in the evolving world of cloud, digital and platforms. Building on its strong 50-year+ heritage and deep industry-specific expertise, Capgemini enables organizations to realize their business ambitions through an array of services from strategy to operations. Capgemini is driven by the conviction that the business value of technology comes from and through people. Today, it is a multicultural company of 300,000 team members in almost 50 countries.Key tasks & activitiesYou act as an experienced data consultant providing data advisory / data governance services to clients and helping to define propositions that address the challenges of Data Migration and Data ManagementAs a vital part of our SAP business unit, you’ll contribute to first-class end-to-end solutions in your assignments. You will play an active role in defining our practices, standards and ways of working, and apply them to your role. Be open to working across organisation and team boundaries to ensure we bring the best to our customersYou help the customer understand the data model in SAPYou take up a role in organizing ETL procedures within a variety of systems, considering the dependencies and requirements. You can easily switch from a managing role (organization, guidance) to a hands-on participant (taking up part of the Extract, Transform, and Load activities)You provide support in proposals, product developments, and further research around Data SolutionsKnowledge & Experience5+ years of demonstrated experience in delivering SAP data model implementationsProven experience in at least one tool for each domain of the SAP Data solutions:Data Migration: LSMW, EMIGALL, S/4 HANA Migration cockpit (incl. direct transfer), Application Link EnablingData Governance and Quality supporting tools: SAP Master Data Governance, Information Lifecycle Management (ILM), Data Archiving, Data Services (BODS), SAP HANA smart data integration and SAP HANA smart data qualityKnowledge on the main functional areas of the SAP ERP solution (either ECC or S/4HANA, e.g. sales & distribution, purchasing, material management, financial management) is a plusIt is beneficial to have experience in SAP developments/ABAP or transition/cutover planningYou like working within a team of colleagues with similar or different skillsets You are customer oriented and are a good listenerYou are pro-active, result-driven, reliable, assertive, proud of your workYou have a consultancy mindset, meaning you are not afraid to speak up, present your views, implementations, … and represent Capgemini at the client You have ambition to grow into the role of an architect or project manager, in which you’ll guide younger people on projects and in their careers What we offerYour career matters to us! Because your goals and needs are constantly evolving, we offer visibility, leeway and support to help you grow and progress in your career. This approach builds notably on our comprehensive competency framework, our personal development, training and career management programs, and our University innovative and business-focused learning curriculums. We promote a culture of diversity. We believe working with talented individuals from different backgrounds and points of view is a strategic advantage and an ongoing opportunity. Diversity enriches our creative solutions and adds value for our clients. With the digital tech sector growing at a rapid pace and women significantly underrepresented in the industry, we are determined to inspire and recruit more women into technology and build diverse teams that reflect the clients we serve. Our Shared values have been at the heart of the group since our formation. They are honesty , boldness , trust , freedom , team spirit , modesty and fun. These values influence the way we meet client needs while respecting the regulatory requirements of each country in which we operate, and the way we promote ethically sound practices within Capgemini and in our partnerships. Last but not least, we will offer you a nice salary package including a company car and various extra-legal benefits such as a group insurance, hospitalization insurance, representation allowance, meal vouchers and the possibility to work up to 70% from home. Get the future you want, apply now!

Job Description Technology & Strategy (Senior) ConsultantsTHE ORGANIZATIONAt Capgemini Invent , we bring to life what’s next for our clients.As the digital innovation, consulting, and transformation brand of the Capgemini Group, Capgemini Invent helps CxOs envision and build what’s next for their organizations. Located in more than 30 offices and 20+ creative studios around the world, its 6,000+ strong team combines strategy , technology, data science, and creative design with deep industry expertise and insights, to develop new digital solutions and business models of the future.Capgemini Invent is an integral part of Capgemini, a global leader in consulting, digital transformation, technology, and engineering services. The Group is at the forefront of innovation to address the entire breadth of clients’ opportunities in the evolving world of cloud, digital, and platforms. Building on its strong 50-year+ heritage and deep industry-specific expertise, Capgemini enables organizations to realize their business ambitions through an array of services from strategy to operations. Capgemini is driven by the conviction that the business value of technology comes from and through people. Today, it is a multicultural company of 270.000 team members in almost 50 countries. With Altran, the Group reported 2019 combined revenues of € 17 billion.FOCUSSING ON YOUR ROLECapgemini is seeking (Senior) Consultantsto grow and strengthen the capabilities of our Business Technology team of Strategists and Management Consultants. Within this team you will :BE PART OF A JOURNEY MADE OF…Innovative Strategy ProjectsSuccessful and fast-paced growth pathsJoint, progressive digital ideasLong-standing corporate culture based on common valuesTransparent career prospects and room for personal initiativesA broad set of training and personal developments opportunities powered by a network of experts• BRING TO LIFE WHAT’S NEXT…Strategic projects in the areas of Digital Transformation, Innovation Strategy, IT Strategy & ArchitectureDigitalization of Organizations and ProcessesDevelopment of future-oriented Operating Models and solutionsManagement Consulting projects, leveraging proven methodologies to reinvent our clients’ businesses HAVE A CONCRETE, VALUED INPUT AS A (SENIOR) CONSULTANT…Lead a stream of work and produce high-quality deliverablesTake full ownership over parts of our value propositionCollaborate with your team peers, industry leaders and our clients to assess challenges critically applying analytical frameworksConceptualize key strategy developments and transformationsMaster key consulting skills; including communication, analysis and teamworkSupporting internal practice development and business development activitiesYOUR SKILLS & EXPERIENCEYou have:1. A KEEN INTEREST INDigital Transformation, Innovation, IT Strategy & Architecture, Cloud Transformation Strategy, Data Strategy, or other technology-oriented fields2. A PASSION FORThe combination of Business Processes and Technological Innovation, Strategic Analysis and Transformation, as well as Conceptual- and Analytical-thinking consulting activities3. STRONG FOUNDATIONSPractical project experience in Technology-oriented transformation or Consulting activitiesA Master’s degree or a Bachelor’s degree combined with professional experienceFluency in English and French or Dutch, with a good command of the other national language4. THE CULTURE AND VALUES WE SHAREHigh level of reliability, team spirit and strong interpersonal skills to thrive in a world-leading management consulting firmAn entrepreneurial, results-oriented and a problem-solving mindsetWillingness to develop yourself individually and grow within our practiceWHAT WE OFFER· MEANINGFUL WORKNo matter the project or customer, your work will have a meaningful impact on society, businesses and your counterparts. You’ll potentially work on a huge variety of projects (some larger than others), so you could gain lots of experience in a short amount of time· COLLABORATION AND INNOVATIONWe believe in creating a partnership with our customers and fostering close collaborations with them. You’ll get to know the customer’s needs and challenges, demonstrating innovative solutions and quickly solving some of the most rewarding challenges.· WELCOMING CULTURE AND DEVELOPMENT ENVIRONMENTCapgemini Invent offers a cultural environment for consultants to learn, to take ownership and contribute to business growth. Our consultants are continuously trained by industry experts on key management consulting skills to acquire industry standards certifications. Examples of these include Agile delivery (Scrum Master, Product Owner, Scaled Agile Framework), enabling technologies (AWS, Azure, Google), Cyber Security (CISSP, CISM) and many more. Client engagements give you the opportunity to work with our leadership and experienced management, where you can learn and challenge them openly to accelerate your hands-on experience, delivery capability and industry insights. You’ll also learn how to write compelling client propositions, structure and lead high-profile transformations, and gain exposure to leading technologies, often taking your idea from a concept to a vision, to a strategy and its execution.Besides work, we cherish a culture of fun and close relationships amongst the co-workers through frequent events, unformal team drinks, and other entertaining setups to encourage face-to-face connections with the wider team. · DIVERSITYCapgemini positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief. We are committed to hiring, developing and retaining the best people to deliver innovative, world-class solutions to our clients. We foster an inclusive culture that enables everyone to achieve their full potential and enjoy a fulfilling career with us. · WORK-LIFE BALANCEWe acknowledge that everyone needs different levels of flexibility at work and embrace this diversity in order to accommodate for all and provide the necessary flexibility to everyone. Our flexible internal policies will enable you to organize your contributions and workplaces in a way that best fits your lifestyle. · A COMPETITIVE REMUNERATION PACKAGECapgemini offers a rewarding salary package includingA company carA complete set of Fringe Benefits on top of an attractive remunerationA package of insurances fully paid by Capgemini

Job Description About the jobAs the digital innovation, design and transformation brand of the Capgemini Group, Capgemini Invent enables CxOs to envision and shape the future of their businesses. Located in more than 36 offices and 37 creative studios around the world, it comprises a 12,000+ strong team of strategists, data scientists, product and experience designers, brand experts and technologists who develop new digital services, products, experiences, and business models for sustainable growth.We have recently extended our Invent family and launched Capgemini Invent in Denmark. This is a unique and exciting time to join the existing strong and established Invent Denmark team and be a part of the continuing growth journey. Invent Denmark, Sweden and Finland are one unit with almost 500 employees, of which 35+ consultants are located in Denmark.Be part of our journey.Engaging in innovative projects with our local and our Nordic Digital Trust & Security teamCollaboration with our and international teams, coupled with driving successful growth in future digital topicsBeing in charge of strategizing and executing transformational projects and leading them to impactful outcomesHaving clear and transparent career prospects and further training opportunities within a global network of expertsEnjoying long-term work-life balance model through our workplace philosophy “Live Your Best Worklife”Get the future you want.Design, development, and operationalisation of business driven cyber and data protection strategies as well as start-of-the-art awareness measuresDesign, drive and execute cybersecurity programs and transformationsDevelopment security target operating models, metrics & KPIs, dashboards and alignment with the leadership teams and board of directorsImplementation of performance level and cyber due diligence assessments (organisation, processes, technology, capabilities, data protection) & benchmarking in the national and international environmentDesign and implement governance, risk, and compliance concepts in an enterprise Level with a classic and entrepreneurial approachGuide our clients to embark on business resiliency transformations through crisis management, disaster recovery, and business continuity exercisesIncrease customer trust and create conformity with global regulatory requirements, for example by establishing approaches for data classification and implementing adequate security measuresAssess and develop cybersecurity as a business initiatives to our clients, such as market studies, embedded offerings and business strategiesYour skills & careerSeveral years of consulting and or practical project experience related to digital change, with a focus within the field of information security, data protection, cybersecurity or resilienceDegree with an economic, legal, technical or information technology focusEnjoying the combination of strategic analysis and conceptual implementation workHigh reliability, team spirit and fit for Capgemini Invent as one of the world's leading management consultancyStrong presentation and facilitation skillsExcellent English knowledge and Danish or another Scandinavian is a plusKnowledge of current security standards (e.g. ISO 2700x, NIST) is an advantageRelevant certifications (e.g. ISO 2700x, CISM, CISA, CISSP, CCSK, CCSP ) and experience with legal and regulatory requirements (e.g. EU-GDPR, NIS2) are an advantageThe position is located in one of our offices in Denmark, Copenhagen or Aarhus, but with readiness to travel and work on projects at our client sites.Do you have questions?You are welcome to contact Head of Digital Trust & Security in Invent Denmark Justas Mikalajunas at [email protected]We will be conducting interviews continuously.Read more about the many opportunities you can offer our clients at our international and Danish websites.Hear Capgemini Denmark’s CEO Claus Rydkjær explain our work philosophy in this short film: https://www.capgemini.com/dk-en/careers/lev-dit-bedste-arbejdsliv/We look forward hearing from you!#LI-DNI

Job Description About our teamOur SAP Data team is made up of a dynamic and passionate group of individuals. With a collective experience ranging from 2 to +20 years, our colleagues have dedicated a significant portion of their careers to Capgemini, showing how much we love it here. From database migrations to data warehouses and dynamic reporting, we take it upon ourselves to maximize data-potential and empower our customers to extract the most value from their data. We are excited to see what insights you can bring to our team and improve our deliveries even more!Key tasks & activitiesAs a data consultant, you provide data advisory and data governance services to clients, and you help in defining propositions that address the challenges of Data Migration and Data ManagementAs a vital part of our SAP business unit, you’ll contribute to first-class end-to-end solutions in your assignments. You will play an active role in defining our practices, standards, and ways of working, and you’ll apply them to your role.You take up a role in organizing ETL procedures within a variety of systems, considering the dependencies and requirements. You can easily switch from a governing role (organization, guidance) to a hands-on participant (taking up part of the Extract, Transform, and Load activities)You provide support in proposals, product developments, and further research around Data SolutionsKnowledge & Experience.3+ years of demonstrated experience in delivering SAP data migration and/or SAP (Master) Data Governance implementations.Proven experience in one or both of the following domains within the SAP Data solutions universe:Data Migration: S/4 HANA Migration Cockpit (incl. direct transfer), LSMW, EMIGALL, Application Link Enabling, Data Services (BODS)Data Governance and Quality supporting tools: SAP Master Data Governance, Information Lifecycle Management (ILM), Data Archiving, Data Services (BODS), SAP HANA smart data integration and SAP HANA smart data qualityThe following skills are a plus:Knowledge on the main functional areas of the SAP ERP solution (either ECC or S/4HANA, e.g. sales & distribution, purchasing, material management, financial management).Basic understanding of programming languages (ABAP, Python, SQL, …).Transition/cutover planning.Key strengths:Confident Communicator: You're not just a team member; you're a spokesperson. We want someone who thrives on expressing ideas and is comfortable taking the lead in client interactions.Team Player: Whether your colleagues share your skillset or bring something entirely different to the table, you're excited to collaborate and learn within a diverse team.Ambitious: Your eyes are set on the future. We're looking for someone eager to evolve from a team player to a team leader.What we offerYour career matters to us! Because your goals and needs are constantly evolving, we offer visibility, leeway and support to help you grow and progress in your career. This approach builds notably on our comprehensive competency framework, our personal development, training and career management programs, and our innovative and business-focused learning curriculums.We promote a culture of diversity. We believe working with talented individuals from different backgrounds and points of view is a strategic advantage and an ongoing opportunity. Diversity enriches our creative solutions and adds value for our clients.With the digital tech sector growing at a rapid pace and women significantly underrepresented in the industry, we are determined to inspire and recruit more women into technology and build diverse teams that reflect the clients we serve.Our Shared values have been at the heart of the group since our formation. They are honesty, boldness , trust , freedom , team spirit , modesty and fun. These values influence the way we meet client needs while respecting the regulatory requirements of each country in which we operate, and the way we promote ethically sound practices within Capgemini and in our partnerships.Last but not least, we will offer you a nice salary package including a company car and various extra-legal benefits such as a group insurance, hospitalization insurance, representation allowance, meal vouchers and the possibility to work up to 70% from home.Get the future you want, apply now!

StellenbeschreibungDu unterstützt unseren Head of Regulatory und das Regulatory-Team bei Ihrer täglichen Arbeit und arbeitest dabei eng mit verschiedenen Abteilungen und der Geschäftsleitung zusammen.Du leistest Projektmanagementunterstützung für Analyse- und Umsetzungsprojekte, einschließlich der Vorbereitung von Präsentationen für das Management.Du unterstützt bei der Erstellung und Weiterentwicklung von internen Unterlagen und Berichten.Du wirst eng mit verschiedenen Interessengruppen und Funktionen bei Scalable zusammenarbeiten (z. B. CEO-Office, Kontrollfunktionen), indem du Vorlagen und Anleitungen für Governance-bezogene Themenstellungen ausarbeitest.Du unterstützt bei der Analyse neuer und bestehender Anforderungen.Du unterstützt im Auslagerungsmanagement (z.B. Risikoanalyse oder Berichterstattung).QualifikationenDu studierst Betriebswirtschaft, Finanzwirtschaft, Recht, Wirtschaftsrecht, Management oder hast einen gleichwertigen AbschlussDu hast bereits erste Erfahrungen im Projektmanagement und/oder in einem Finanzdienstleistungsunternehmen gesammeltDu hast ein starkes Interesse an aufsichtsrechtlichen ThemenstellungenDu kennst bereits regulatorische Anforderungen für Finanzdienstleistungsunternehmen (z.B. MaRisk, BAIT, etc.)Du besitzt die Fähigkeit in einem schnelllebigen Umfeld detailorientiert zu arbeitenDu hast sehr gute Deutschkenntnisse (C2-Niveau) und Englischkenntnisse (C1-Niveau) in Wort und SchriftMindestdauer des Praktikums: 3 MonateZusätzliche InformationenWerde Teil eines der am schnellsten wachsenden und sichtbarsten Fintech-Startups in Europa und unterstütze unsere Mitarbeiter dabei, einen innovativen Service zu schaffen, der einen wesentlichen Einfluss auf das Leben unserer Kunden hatZusammenarbeit mit einem internationalen, vielfältigen, integrativen und wachsenden Team, das es liebt, die besten Produkte für unsere Kunden zu entwickelnArbeite flexibel in unserem zentralen Office mitten in MünchenBei uns werden sowohl Pflichtpraktika, als auch freiwillige Praktika vergütetInterne Knowledge Sharing Sessions über die Grenzen Deines Teams hinausProduktives Arbeiten mit modernster Hardware und Tools Standort Scalable GmbH, Munich

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.We are looking for a Senior Clinical Research Associate to join our team in GermanyThe Sr CRA will be responsible for the following tasks: Governs quality standards for trial monitoring activities. Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines and Allucent SOPs for monitoring requirements. Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols. Tracks and supervises collection of ongoing study data for purpose of regular project status reporting. Collects and reviews regulatory documents as required. Prepares site visit reports and telephone contact reports. Maintains and updates CTMS in compliance with SOPs and study-specific directives. Acts as Document Owner for collected documents. May participate in the start-up process including preparing Informed Consent forms, developing study documents, EC / CA submissions, and / or site contract management Aims to pro-actively prevent and / or mitigate issues. Resolves site issues, including site recruitment challenges, and determines status for IP shipment. Acts as the main line of communication between the project team and the site staff. Works in collaboration with Allucent Centralized Monitoring Team to evaluate risk-based monitoring activities to facilitate oversight of the study conduct at the sites and prevent issues. Activities are related to but not limited to: Investigational Product supplies, non-IP study supplies, subject eligibility, protocol compliance, facilities, and PI oversight. Identifies potential logistical/practical problems and support Project team to create solutions / contingency plans, with timeframes for resolution. Ensures the continuous maintenance of the Trial Master File and Investigator Site File. Assists the Project Manager (PM) and Clinical Team Leader (CTL) with generation of study specific forms for completion by CRA and Investigators and follow up with the teams to ensure timely completion and submission. Works with Project Manager (PM); Clinical Team Leader (CTL), SSU (Study Start Up) team members or sponsor to ensure authorization of regulatory documents and site contracts. Attends Investigator Meetings (IM) to include organizing and presenting at investigator meetings. and study specific training meetings. May translate, coordinate translations or review completed translations of the essential documents as required. May participates in feasibility and/or site identification activities. Contacts local opinion leaders, medical consultants or specified investigators and identifies sites with the potential for participation. May follow feasibility procedures for documentation of feasibilities performed in collaboration with the Study Start Up Department. Where applicable, identifies the documentation required for review by Regulatory Authorities and Ethical Committees. May prepare Regulatory and Ethics Committee submissions working in conjunction with Study Start Up Department. Ensure written approvals are obtained and distributed appropriately prior to Site Initiation. Prepares and attends an Assessment Visit with a more senior CRA, CTL or Clinical Research Manager as required. May process interim and final payments to Investigators, including preliminary calculations, review and approval from Project Management, liaison with finance, logging trial expenditure, receipts, invoices, and income. Assists the Project Team with the day-to-day management of critical studies as required, including attendance at team meetings. Provides secondary in-house review of CRFs (if required). Support site staff in preparation for study related site audits and inspections. Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions. May be assigned other tasks / activities / responsibilities related to the study execution in the country. May support initiatives in the country, GCO, and / or CTO to contribute to improvements and quality. Must work both independently and in a team environment. Requirements At least three years clinical monitoring experience and/or relevant clinical trial experience. Relevant life science degree / health care / nursing background and/or related degree. Sound knowledge of medical terminology and clinical monitoring process. Strong communication in Local and English language in both written and verbal skills. Strong interpersonal and organizational skills. Ability to translate guidelines, rules and regulations in clear and usable recommendations Representative, outgoing and client focused Ability to work in a fast-paced challenging environment of a growing company In-depth therapeutic and protocol knowledge Ability to perform travel an average of 65%, depending on project needs. In-depth therapeutic and protocol knowledge as provided in previous, or company provided training. Attention to detail. Ability to work independently and to effectively prioritize tasks, establish, and maintain strong working relationships with co-workers, managers, investigators, site personnel and clients. Demonstrated ability to manage multiple projects. Administrative excellence Proficiency with various computer applications such as Word, Excel, and PowerPoint required Demonstrated ability to develop, organize and manage new skills and tasks and mentor colleagues. Ability to manage multiple projects Benefits Comprehensive benefits package Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for fully remote working or hybrid Working Model Leadership and mentoring opportunities Internal growth opportunities and career progression More task variety Financially rewarding internal Employee Referral Program Access to online soft-skills and technical training via GoodHabitz and internal platforms To all recruitment agencies: Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes#LI-BL1 Standort Allucent, Munich

Senior Consultant (m/w/d) Umwelt-Compliance Standort: Berlin, Frankfurt am Main, Leverkusen oder Moers Als europäisches Umweltberatungsunternehmen konzentrieren wir uns in unserer täglichen Arbeit auf die Gestaltung einer nachhaltigen Lebensumwelt für uns und für künftige Generationen. Seit über 90 Jahren unterstützen und beraten mittlerweile über 1.200 TAUW-Expert:innen verschiedener Fachbereiche weltweit Industrie- und Immobilienunternehmen sowie Investoren und öffentliche Auftraggeber bei umweltrelevanten Fragestellungen. Im Team arbeitest du an spannenden Projekten und hast die Möglichkeit, dich aktiv bei uns einzubringen und wirklich etwas zu bewirken – getreu dem Motto LIVE YOUR AMBITION. Wie du dich einbringst In deiner Funktion als Senior Consultant (m/w/d) berätst du unsere Kunden bei Fragen rund um das Thema Umwelt Compliance und arbeitest gemeinsam mit dem Team an innovativen Lösungen. Deine Aufgaben umfassen: Durchführung von Umwelt-Compliance-Audits Management internationaler Compliance-Programme für führende Industrieunternehmen Prüfung und Qualitätssicherung der Auditberichte Technische, rechtliche und finanzielle Risikobewertung von Umweltaspekten Schnittstellenfunktion zu den Disziplinen Managementsysteme und Arbeitssicherheits-Compliance Was dich zur idealen Verstärkung unseres Teams macht Um diese Funktion gut ausüben zu können, solltest du über ein abgeschlossenes (Fach-)Hochschulstudium der Geo-, Natur-, Umwelt- oder Ingenieurwissenschaften bzw. eine vergleichbare Qualifikation verfügen. Des Weiteren überzeugst du durch: Mehrjährige Berufserfahrung im Umweltschutz, in Regulatory Compliance oder verwandten Bereichen Fundierte Kenntnisse des deutschen Umweltrechts Kenntnisse im Bereich Health & Safety, Environmental Due Diligence und/oder Environmental Social Governance sind von Vorteil Erfahrung in Qualitätssicherung, Projektkoordination und Budgetverwaltung Verhandlungssichere Deutsch- und Englischkenntnisse (in Wort und Schrift) Teamgeist, Flexibilität, Neugier sowie Reisebereitschaft Deine Benefits Wir arbeiten gern für unser gemeinsames Ziel, eine lebenswerte Umwelt zu gestalten – in flachen Hierarchien, mit Spaß bei der Sache und in einem Unternehmen, das zu 100% in den Händen seiner Mitarbeitenden liegt. Aber natürlich bieten wir noch weiteres: Flexible Arbeitszeiten, tageweise mobiles Arbeiten und verschiedene Teilzeitmodelle Umfassendes Vergütungspaket mit leistungsgerechtem Gehalt, Gewinnbeteiligung, Anteilszertifikaten, Kinderbetreuungszuschuss u.v.m. 30+ Urlaubstage Alters- und Gesundheitsvorsorge, inkl. Kostenerstattung für Sportkurse oder Mitgliedschaften im Fitnessstudio JobRad und bezuschusstes "Deutschlandticket" Zahlreiche interne und externe Weiterbildungs- und Entwicklungsmöglichkeiten Ist der Job etwas für dich? Dann sende uns direkt deine Bewerbungsunterlagen über den Button ‘Direkt bewerben'. Du kannst dich auch dann bewerben, wenn dein Fachwissen nicht perfekt mit dem angeforderten Profil übereinstimmt. Wir freuen uns auf deine Bewerbung! E-Mail anzeigen www.tauw.de/karriere Standort Tauw GmbH, Berlin

For our Global Clinical Safety and Pharmacovigilance department, we are looking for an Associate Director Safety Risk Management (m/f/x) Fulltime / permanent/ non-tariff R-224246 The Opportunity As Associate Director Safety Risk Management, located within CSLs Global Clinical Safety and Pharmacovigilance department, you will provide strategic risk management support for CSL products under the direction of the Senior Director Safety Risk Management Lead. You will be responsible for implementing projects and activities related to Safety Risk Management, including procedural enhancements (in collaboration with partner functions), training and awareness measures, strategies, and additional Risk Minimization Measure implementations. The Role One of your main responsibilities will be to lead the development and promotion of Safety Risk Management best practices, processes, tools, and policies to ensure consistent safety risk management excellence across the organization. You will guide product teams strategically during the development of risk management planning documents, contributing recommendations for risk management activities, including country-specific PV and risk minimization activities (e.g. educational materials). You will provide global support for additional Risk Minimization Activities implementation and tracking, and you will lead enhancement activities for these tracking processes. Another focus will be for you to drive the development, review and contribution to safety relevant SOPs and improvement of safety relevant procedures, and to develop materials, that ensure the consistent use of these procedures. You will be accountable for training the organization on Safety Risk Management processes. Further on you may drive cross-functional collaboration projects with partner functions to enhance Safety Risk Management processes. You will contribute to best-in-class RMPs and support responses to queries from Health Authorities with the highest quality standards. As a liaison for in- and external collaborators you will develop programs and processes to meet regulatory requirements and enhance internal processes. In this role, you will maintain and share knowledge of evolving global regulatory risk management requirements with relevant functions of the organization. In regulatory agency inspections and internal audits you will represent Safety Risk Management, you will address findings related to Risk Management, and will ensure that resultant Corrective Action Plans are implemented efficiently and effectively. Your Skills and Experience University Degree (Diploma or MSc) in Life Sciences (e.g. MD, PharmD, biology, nursing, nutrition), Quality or in related area with relevant experience (Other degrees (e.g. BS, BA) and certifications considered if commensurate with related Pharmacovigilance experience) Significant experience in PV across all key PV processes 8-10 years of experience in multinational biotechnology or pharmaceutical industry, 5-7 years of experience in Pharmacovigilance/Safety Risk Management, preferably 3 years of experience in GCSP Expert knowledge of local/international regulations and PV processes Experience with regulatory inspections, administration of complex data sets and relevant software applications Experience with project-managing CAPA and SOP development Experience in GxP What we offer Innovative work-environment at our CSL-subsidized company bike leasing Childcare “Kita Froschkönig” for up to 14 children (from 6 months till 3 years old) Access to Gym facility on campus 2 Wellness days per year (additional paid time off) Family services such as psychological support, legal advisory, family care services and more for you and your direct family For more information, please check out our global benefits below. We are looking forward to your application. Please ensure to apply online with your CV and certifications as well as your salary expectation. Our Benefits We encourage you to make your well-being a priority. It’s important and so are you. Learn more about at CSL. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about . We want CSL to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about at CSL. Do work that matters at CSL Behring! Standort 1017 CSL Behring Innovation GmbH, Marburg

For our Global Clinical Safety and Pharmacovigilance department, we are looking for an Associate Director Safety Risk Management (m/f/x) Fulltime / permanent/ non-tariff R-224246 The Opportunity As Associate Director Safety Risk Management, located within CSLs Global Clinical Safety and Pharmacovigilance department, you will provide strategic risk management support for CSL products under the direction of the Senior Director Safety Risk Management Lead. You will be responsible for implementing projects and activities related to Safety Risk Management, including procedural enhancements (in collaboration with partner functions), training and awareness measures, strategies, and additional Risk Minimization Measure implementations. The Role One of your main responsibilities will be to lead the development and promotion of Safety Risk Management best practices, processes, tools, and policies to ensure consistent safety risk management excellence across the organization. You will guide product teams strategically during the development of risk management planning documents, contributing recommendations for risk management activities, including country-specific PV and risk minimization activities (e.g. educational materials). You will provide global support for additional Risk Minimization Activities implementation and tracking, and you will lead enhancement activities for these tracking processes. Another focus will be for you to drive the development, review and contribution to safety relevant SOPs and improvement of safety relevant procedures, and to develop materials, that ensure the consistent use of these procedures. You will be accountable for training the organization on Safety Risk Management processes. Further on you may drive cross-functional collaboration projects with partner functions to enhance Safety Risk Management processes. You will contribute to best-in-class RMPs and support responses to queries from Health Authorities with the highest quality standards. As a liaison for in- and external collaborators you will develop programs and processes to meet regulatory requirements and enhance internal processes. In this role, you will maintain and share knowledge of evolving global regulatory risk management requirements with relevant functions of the organization. In regulatory agency inspections and internal audits you will represent Safety Risk Management, you will address findings related to Risk Management, and will ensure that resultant Corrective Action Plans are implemented efficiently and effectively. Your Skills and Experience University Degree (Diploma or MSc) in Life Sciences (e.g. MD, PharmD, biology, nursing, nutrition), Quality or in related area with relevant experience (Other degrees (e.g. BS, BA) and certifications considered if commensurate with related Pharmacovigilance experience) Significant experience in PV across all key PV processes 8-10 years of experience in multinational biotechnology or pharmaceutical industry, 5-7 years of experience in Pharmacovigilance/Safety Risk Management, preferably 3 years of experience in GCSP Expert knowledge of local/international regulations and PV processes Experience with regulatory inspections, administration of complex data sets and relevant software applications Experience with project-managing CAPA and SOP development Experience in GxP What we offer Innovative work-environment at our CSL-subsidized company bike leasing Childcare “Kita Froschkönig” for up to 14 children (from 6 months till 3 years old) Access to Gym facility on campus 2 Wellness days per year (additional paid time off) Family services such as psychological support, legal advisory, family care services and more for you and your direct family For more information, please check out our global benefits below. We are looking forward to your application. Please ensure to apply online with your CV and certifications as well as your salary expectation. Our Benefits We encourage you to make your well-being a priority. It’s important and so are you. Learn more about at CSL. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about . We want CSL to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about at CSL. Do work that matters at CSL Behring! Standort CSL Plasma, Marburg

Overview Summary The Associate Director Therapeutic Area Lead Solid Tumors / Pipeline is part of the Medical Affairs Team and provides a bridge between Clinical Development, Medical Affairs, and the commercial organization at a senior mastery level. He/she will be involved in a wide range of activities for inline and pipeline products. This is a very diverse role and a unique opportunity where you can cover the whole spectrum of drug development in various therapeutic areas. As part of an innovative team, he/she will gain medical insights and in-depth market understanding based on related IT analysis of the assigned indications Duties and Responsibilities Constantly builds and maintains expertise in the assigned areas (tumor entities, products), regarding available literature, treatment options, disease environment and product data, key contact for training and all educational approaches. Gains in-depth knowledge in early development indications and analyzes different data sources resulting in meaningful reports and derived strategies. Identifies and engages with internal and external experts when appropriate, for participation in medical communications as well as consultants for content development, when necessary Provides oversight and contributes to the preparation and delivery of high-quality content and all educational and medical communication materials (e.g. planning for medical society presence, abstracts, and publications) Streamlines product communication, works with external and internal resources on the development of multi-channel communication strategies and materials (for internal and field/external use) and medical event planning Creative and open approach for new ways of working in the light of digitalization and adapted content communication needs. Acts as medical point of contact for clinical studies within solid tumor indications and provides continuous support to study centers and the ClinOps Team. Screens the German medical landscape for relevant KEEs and research groups within retrospective indications and research areas Participates in relevant cross-functional medical planning, working groups and task forces Accounts for congress medical communication activities (e.g., congress medical booth materials and planning) and participates in congress reporting and summaries Ensures the proper pre-medical and medical review of medical materials, serves as Information officer for all material related to solid tumors/pipeline. Drives implementation of the medical/non-promotional plans for respective products / Gives medical input into local brand planning processes and to respective brand teams Ensures that HCP and educational activities are of high scientific quality and are in line with compliance regulations Contributes positively to a strong culture of business integrity and ethics and embraces the Mission, Vision and Values of the organization. Acts within compliance, regulatory and legal requirements as well as within company guideline Demonstrates medical and scientific expertise to core business strategy and marketing/business development plans, strongly contributes to the development of and updates to the strategic medical plans Ensures that strategically aligned scientific communication points, elements from other internal guidance and resource documents, and key data are included appropriately in tactics, and that statements and conclusions are accurate and supported by appropriate data Accountable for creating and managing resources within the annual medical affairs brand budget Provides medical leadership and actively contributes to market access dossiers Oversees the agenda development, content creation, and execution for educational symposia, internal meetings/summits and advisory boards Supports advisory board meetings and investigator meetings. Provides support for content development and delivering clinical presentations at medical meetings Develops and delivers presentations to colleagues and management as needed, provides strong input to briefing documents, written communications, Frequently Asked Questions documents, backgrounders, newsletters, slide decks, and medical information letters etc. Requirements MD, PharmD or PhD in life sciences Long standing experience in the pharmaceutical industry, preferably in oncology 5-7 years of relevant working experience in similar roles Proven track record in preparing for product launches and successful life cycle management Knowledge in development and implementation of clinical trials Experienced in material review in the role of an Information Officer Excellent communication skills and ability to present scientific data Structured approach to project management. Ability to work independently and effectively in complex, rapidly changing environments Analytical mind setting, entrepreneurial approach, hands-on Ability to travel up to 25% of working time Excellent spoken and written German and English Proficient in Veeva, Microsoft Office and relevant public medical data sources Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. We Respect Your Privacy Learn more at: The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process . You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte’s data protection practices . By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable). Please contact privacy@ if you have any questions or concerns or would like to exercise your rights. Standort Incyte, Munich

Company DescriptionFor the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.Job DescriptionThis Senior Consultant Product Lifecycle Management - Biologics position is considered a subject matter expert and plays a pivotal role in some of our most challenging and rewarding drug development projects. In this exciting function, you will work as a project manager in order to create and implement key strategic plans for a variety of life-science clients. This role offers great diversity; the chance to learn new subject matters and will allow you to be at forefront of some of the most fascinating and innovative development projects globally.Responsibilities include:The Senior Consultant Product Lifecycle Management will manage complex manufacturing and transfer projects to successful and timely decision points for products under development or currently licensedBe a key Project leader for a range of drug development projects within the Biological spacePartner with the department head to manage the development and execution of project team strategy and to optimize team effectiveness in achieving project objectives in alignment with budget and timelineEstablish and maintain functionally integrated project schedules to enable accurate project, financial, and portfolio analyses and ensure accurate inputs are provided into business planning processesEnsure alignment with project sub-teams and functional partnersOversee and prepare project team budget including resources and costs, collaborating with finance and other cross-functional departmentsEnsure project team activities and decisions are clearly communicated, documented, and archived, act as primary contact for project team-related informationFacilitate project team meetings, cross-functional communication, and decision making, ensuring alignment with internal and external stakeholdersIdentify, recommend and manage the implementation of process and other improvements; whether pertinent to departmental and/or corporateAssist Operations in staffing client projects to enable the company to execute the strategic plan efficiently and effectively, and to meet revenue and profit goals based on personnel skills development and client needs.Other duties as assignedExperience requiredBSc or above in a Life-sciences disciplineMust possess at least 10 or more years’ experience working within the life-sciences sectorSubstantial exposure to Strategic Project management linked to Drug development is keyKey exposure to Biological development is a mustProven experience of multiple areas which would include technical transfers and drug development activitiesFluency in English (another EU language would be preferred but not essential)Ability to develop proposals and organize and conduct professional presentations to (potential) clientsHands-on experience with (remote) CMO managementOutstanding knowledge of overall drug development process and cGMP and ISO relevant to pharmaceutical/biotech and medical device organizations.Excellent analytical skills, with an ability to communicate complex issues in a simple wayRemote working opportunities are availableAdditional InformationWe celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*** Standort ProPharma, Munich

Company DescriptionFor the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.Job DescriptionThis Senior Consultant Product Lifecycle Management - Biologics position is considered a subject matter expert and plays a pivotal role in some of our most challenging and rewarding drug development projects. In this exciting function, you will work as a project manager in order to create and implement key strategic plans for a variety of life-science clients. This role offers great diversity; the chance to learn new subject matters and will allow you to be at forefront of some of the most fascinating and innovative development projects globally.Responsibilities include:The Senior Consultant Product Lifecycle Management will manage complex manufacturing and transfer projects to successful and timely decision points for products under development or currently licensedBe a key Project leader for a range of drug development projects within the Biological spacePartner with the department head to manage the development and execution of project team strategy and to optimize team effectiveness in achieving project objectives in alignment with budget and timelineEstablish and maintain functionally integrated project schedules to enable accurate project, financial, and portfolio analyses and ensure accurate inputs are provided into business planning processesEnsure alignment with project sub-teams and functional partnersOversee and prepare project team budget including resources and costs, collaborating with finance and other cross-functional departmentsEnsure project team activities and decisions are clearly communicated, documented, and archived, act as primary contact for project team-related informationFacilitate project team meetings, cross-functional communication, and decision making, ensuring alignment with internal and external stakeholdersIdentify, recommend and manage the implementation of process and other improvements; whether pertinent to departmental and/or corporateAssist Operations in staffing client projects to enable the company to execute the strategic plan efficiently and effectively, and to meet revenue and profit goals based on personnel skills development and client needs.Other duties as assignedExperience requiredBSc or above in a Life-sciences disciplineMust possess at least 10 or more years’ experience working within the life-sciences sectorSubstantial exposure to Strategic Project management linked to Drug development is keyKey exposure to Biological development is a mustProven experience of multiple areas which would include technical transfers and drug development activitiesFluency in English (another EU language would be preferred but not essential)Ability to develop proposals and organize and conduct professional presentations to (potential) clientsHands-on experience with (remote) CMO managementOutstanding knowledge of overall drug development process and cGMP and ISO relevant to pharmaceutical/biotech and medical device organizations.Excellent analytical skills, with an ability to communicate complex issues in a simple wayRemote working opportunities are availableAdditional InformationWe celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*** Standort ProPharma, Frankfurt

Locations: Switzerland, GermanyWork mode: Fully remoteContract: PermanentWe are looking for an experienced Regulatory Affairs professional to join our dynamic international consulting team and play a key role on a project for one of our key clients.Company OverviewArcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital transformation since 2001. Our focus lies in creating value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.We are a medium-sized international consulting firm dedicated to Life Sciences, with a unique and inspiring culture. Our distinctive culture is the driving force behind our success; it is deeply rooted in our purpose and behaviors.We are owned by a charitable Foundation; our key differentiator is that we contribute to social causes every year. This ethos is not just a part of our identity; it is our way of life. Our motto, "We make healthcare better," reflects the unwavering commitment we have to improving the lives of people through the work we do.Our culture fosters collaboration, innovation, and a sense of community that sets us apart from the rest. We are living our values every day. Our leadership is expected to lead by example, demonstrating a dedication to our mission and values.We embrace diversity and inclusivity, and we believe in giving back to the community. Together, we are not just consultants; we are agents of change, and our culture is the driving force behind our shared purpose.Responsibilities:Consult our clients in development and implementation of regulatory strategies, identifying the most efficient and compliant regulatory pathways to bring clients’ products to the marketAdvise our clients on the regulatory data (e.g. EUDAMED) and information necessary to support dossier submission mainly to EU and US health authoritiesPerform gap analysis on existing dossiers for regulatory approvals or clearanceSupport clients in the liaison with health authorities, facilitating effective communication and swift resolution of issuesConsult and support our clients in implementation of additional components beyond the standard ISO 13485, that are required for a Quality Management System (QMS) that incorporates Artificial Intelligence (AI), e.g. focus on data management, AI-specific risk management, ethical considerationsIn close collaboration with our clients support from regulatory perspective implementation and maintenance of clients’ Quality Management Systems acc. to ISO 13485Keep abreast of changes in global regulatory guidelines, standards, and policies, interpreting their implications for client projectsProvide training to clients' internal teams on global regulations, guidelines, and processesBe a driver of our business development and regulatory affairs servicesYour profileBachelor's or Master's degree in Life Sciences, Regulatory Affairs or correlated fieldMinimum of 10 years' experience in Regulatory Affairs within the MedTech industriesIn-depth knowledge and understanding of EU and US MedTech regulations and submission processesExperience in communication and exchange with Health Authorities for SaMD, AI, Robotics submissions, like FDA, EMADemonstrated success in preparing and managing EU and US submissions and approvals, incl. 510kHigh degree of quality awarenessStrong attention to detail, self-contained, and responsible way of workingGood understanding of Good Manufacturing Practices (GMP)Proficiency in project management and ability to handle multiple projects simultaneouslyExcellent English written, and verbal communication skills, German and other languages are a plusAbility to work in international and interdisciplinary teamsWillingness to continuously improve and to grow with new challengesWillingness to travel, including overseasWhy ArcondisWillingness to continuously improve, grow with new challenges and travelSelf-organizing, flat hierarchyBecome part of an established company with a start-up mindsetPossibility to shape the Arcondis culture and build the team/communityFlexible workplace Standort Arcondis Group, Frankfurt

EinleitungEine gute Idee war der Ursprung, ein erfolgreiches Konzept ist das Ergebnis. Qualität zum guten Preis möglichst vielen Menschen anbieten zu können treibt uns an - mittlerweile weltweit, denn wir sind Lidl. Hier ist das berufliche Zuhause vielfältiger Talente. Ob im Einkauf, in der Logistik, im Warengeschäft oder in der IT; ob als Impulsgeber, Gestalter oder Dienstleister der Länder. Wir suchen Anpacker, Durchstarter, Möglichmacher und bieten spannende Aufgaben und Projekte in einem dynamischen und internationalen Umfeld. Bei Lidl findet jeder seine persönliche Herausforderung. Denn Lidl lohnt sich.Deine AufgabenUnterstützung unseres Beraterteams für die Dauer von 5 bis 6 Monaten in strategischen Projekten über alle Phasen hinweg - von der Analyse, über die Konzeptentwicklung bis zur UmsetzungEinblicke in die Vorbereitung von und Teilnahme an Workshops zur Konzeptentwicklung und Optimierung Lidl-interner ProzesseEnge Zusammenarbeit mit verschiedenen Fachbereichen zu ausgewählten Beratungsprojekten und Unterstützung bei der Vorbereitung von Entscheidungsterminen mit dem Top-ManagementEinbringen bei der Erarbeitung strategischer Fragestellungen unter Berücksichtigung zukünftiger Trends und ZieleKennenlernen von Tools und Methoden der BeratungsarbeitDein ProfilMasterstudium oder fortgeschrittenes Bachelorstudium der WirtschaftswissenschaftenIdealerweise erste Praktika/Projektarbeiten in einer Management-BeratungAusgeprägte Kommunikationsfähigkeit und TeamfähigkeitPraktische Erfahrungen in den Themen Agile & Lean wünschenswertAnwendungssichere MS Office Kenntnisse, insbesondere in Excel und PowerPointErste Erfahrungen in der Workshop-Gestaltung wünschenswertSehr gute DeutschkenntnisseWir bietenLidl legt Wert darauf, dass sich deine Zeit bei uns lohnt! Deshalb kannst du bei uns nicht nur deine Finanzen aufbessern: Du gewinnst wertvolle Praxiseinblicke in „deinen“ Fachbereich und lernst die Herausforderungen im Tagesgeschäft kennen. Dabei steht dir nicht nur während der Einarbeitung ein fester Ansprechpartner zur Seite. Du hast zu jeder Zeit Zugriff auf das Expertenwissen deines festen Ansprechpartners und das Know-how deiner hilfsbereiten Kolleginnen und Kollegen. Lerne das kollegiale Umfeld und deine beruflichen Möglichkeiten bei Lidl kennen. Und nutze die Chance, dir ein erstes Karrierenetzwerk aufzubauen.

EinleitungEine gute Idee war der Ursprung, ein erfolgreiches Konzept ist das Ergebnis. Qualität zum guten Preis möglichst vielen Menschen anbieten zu können treibt uns an - mittlerweile weltweit, denn wir sind Lidl. Hier ist das berufliche Zuhause vielfältiger Talente. Ob im Einkauf, in der Logistik, im Warengeschäft oder in der IT; ob als Impulsgeber, Gestalter oder Dienstleister der Länder. Wir suchen Anpacker, Durchstarter, Möglichmacher und bieten spannende Aufgaben und Projekte in einem dynamischen und internationalen Umfeld. Bei Lidl findet jeder seine persönliche Herausforderung. Denn Lidl lohnt sich.Deine AufgabenUnterstützung unseres Beraterteams für die Dauer von 5 bis 6 Monaten in strategischen Projekten über alle Phasen hinweg - von der Analyse, über die Konzeptentwicklung bis zur UmsetzungEinblicke in die Vorbereitung von und Teilnahme an Workshops zur Konzeptentwicklung und Optimierung Lidl-interner ProzesseEnge Zusammenarbeit mit verschiedenen Fachbereichen zu ausgewählten Beratungsprojekten und Unterstützung bei der Vorbereitung von Entscheidungsterminen mit dem Top-ManagementEinbringen bei der Erarbeitung strategischer Fragestellungen unter Berücksichtigung zukünftiger Trends und ZieleKennenlernen von Tools und Methoden der BeratungsarbeitDein ProfilMasterstudium oder fortgeschrittenes Bachelorstudium der WirtschaftswissenschaftenIdealerweise erste Praktika/Projektarbeiten in einer Management-BeratungAusgeprägte Kommunikationsfähigkeit und TeamfähigkeitPraktische Erfahrungen in den Themen Agile & Lean wünschenswertAnwendungssichere MS Office Kenntnisse, insbesondere in Excel und PowerPointErste Erfahrungen in der Workshop-Gestaltung wünschenswertSehr gute DeutschkenntnisseWir bietenLidl legt Wert darauf, dass sich deine Zeit bei uns lohnt! Deshalb kannst du bei uns nicht nur deine Finanzen aufbessern: Du gewinnst wertvolle Praxiseinblicke in „deinen“ Fachbereich und lernst die Herausforderungen im Tagesgeschäft kennen. Dabei steht dir nicht nur während der Einarbeitung ein fester Ansprechpartner zur Seite. Du hast zu jeder Zeit Zugriff auf das Expertenwissen deines festen Ansprechpartners und das Know-how deiner hilfsbereiten Kolleginnen und Kollegen. Lerne das kollegiale Umfeld und deine beruflichen Möglichkeiten bei Lidl kennen. Und nutze die Chance, dir ein erstes Karrierenetzwerk aufzubauen.

EinleitungEine gute Idee war der Ursprung, ein erfolgreiches Konzept ist das Ergebnis. Qualität zum guten Preis möglichst vielen Menschen anbieten zu können treibt uns an - mittlerweile weltweit, denn wir sind Lidl. Hier ist das berufliche Zuhause vielfältiger Talente. Ob im Einkauf, in der Logistik, im Warengeschäft oder in der IT; ob als Impulsgeber, Gestalter oder Dienstleister der Länder. Wir suchen Anpacker, Durchstarter, Möglichmacher und bieten spannende Aufgaben und Projekte in einem dynamischen und internationalen Umfeld. Bei Lidl findet jeder seine persönliche Herausforderung. Denn Lidl lohnt sich.Deine AufgabenUnterstützung unseres Beraterteams für die Dauer von 5 bis 6 Monaten in strategischen Projekten über alle Phasen hinweg - von der Analyse, über die Konzeptentwicklung bis zur UmsetzungEinblicke in die Vorbereitung von und Teilnahme an Workshops zur Konzeptentwicklung und Optimierung Lidl-interner ProzesseEnge Zusammenarbeit mit verschiedenen Fachbereichen zu ausgewählten Beratungsprojekten und Unterstützung bei der Vorbereitung von Entscheidungsterminen mit dem Top-ManagementEinbringen bei der Erarbeitung strategischer Fragestellungen unter Berücksichtigung zukünftiger Trends und ZieleKennenlernen von Tools und Methoden der BeratungsarbeitDein ProfilMasterstudium oder fortgeschrittenes Bachelorstudium der WirtschaftswissenschaftenIdealerweise erste Praktika/Projektarbeiten in einer Management-BeratungAusgeprägte Kommunikationsfähigkeit und TeamfähigkeitPraktische Erfahrungen in den Themen Agile & Lean wünschenswertAnwendungssichere MS Office Kenntnisse, insbesondere in Excel und PowerPointErste Erfahrungen in der Workshop-Gestaltung wünschenswertSehr gute DeutschkenntnisseWir bietenLidl legt Wert darauf, dass sich deine Zeit bei uns lohnt! Deshalb kannst du bei uns nicht nur deine Finanzen aufbessern: Du gewinnst wertvolle Praxiseinblicke in „deinen“ Fachbereich und lernst die Herausforderungen im Tagesgeschäft kennen. Dabei steht dir nicht nur während der Einarbeitung ein fester Ansprechpartner zur Seite. Du hast zu jeder Zeit Zugriff auf das Expertenwissen deines festen Ansprechpartners und das Know-how deiner hilfsbereiten Kolleginnen und Kollegen. Lerne das kollegiale Umfeld und deine beruflichen Möglichkeiten bei Lidl kennen. Und nutze die Chance, dir ein erstes Karrierenetzwerk aufzubauen.

EinleitungEine gute Idee war der Ursprung, ein erfolgreiches Konzept ist das Ergebnis. Qualität zum guten Preis möglichst vielen Menschen anbieten zu können treibt uns an - mittlerweile weltweit, denn wir sind Lidl. Hier ist das berufliche Zuhause vielfältiger Talente. Ob im Einkauf, in der Logistik, im Warengeschäft oder in der IT; ob als Impulsgeber, Gestalter oder Dienstleister der Länder. Wir suchen Anpacker, Durchstarter, Möglichmacher und bieten spannende Aufgaben und Projekte in einem dynamischen und internationalen Umfeld. Bei Lidl findet jeder seine persönliche Herausforderung. Denn Lidl lohnt sich.Deine AufgabenUnterstützung unseres Beraterteams für die Dauer von 5 bis 6 Monaten in strategischen Projekten über alle Phasen hinweg - von der Analyse, über die Konzeptentwicklung bis zur UmsetzungEinblicke in die Vorbereitung von und Teilnahme an Workshops zur Konzeptentwicklung und Optimierung Lidl-interner ProzesseEnge Zusammenarbeit mit verschiedenen Fachbereichen zu ausgewählten Beratungsprojekten und Unterstützung bei der Vorbereitung von Entscheidungsterminen mit dem Top-ManagementEinbringen bei der Erarbeitung strategischer Fragestellungen unter Berücksichtigung zukünftiger Trends und ZieleKennenlernen von Tools und Methoden der BeratungsarbeitDein ProfilMasterstudium oder fortgeschrittenes Bachelorstudium der WirtschaftswissenschaftenIdealerweise erste Praktika/Projektarbeiten in einer Management-BeratungAusgeprägte Kommunikationsfähigkeit und TeamfähigkeitPraktische Erfahrungen in den Themen Agile & Lean wünschenswertAnwendungssichere MS Office Kenntnisse, insbesondere in Excel und PowerPointErste Erfahrungen in der Workshop-Gestaltung wünschenswertSehr gute DeutschkenntnisseWir bietenLidl legt Wert darauf, dass sich deine Zeit bei uns lohnt! Deshalb kannst du bei uns nicht nur deine Finanzen aufbessern: Du gewinnst wertvolle Praxiseinblicke in „deinen“ Fachbereich und lernst die Herausforderungen im Tagesgeschäft kennen. Dabei steht dir nicht nur während der Einarbeitung ein fester Ansprechpartner zur Seite. Du hast zu jeder Zeit Zugriff auf das Expertenwissen deines festen Ansprechpartners und das Know-how deiner hilfsbereiten Kolleginnen und Kollegen. Lerne das kollegiale Umfeld und deine beruflichen Möglichkeiten bei Lidl kennen. Und nutze die Chance, dir ein erstes Karrierenetzwerk aufzubauen.

EinleitungEine gute Idee war der Ursprung, ein erfolgreiches Konzept ist das Ergebnis. Qualität zum guten Preis möglichst vielen Menschen anbieten zu können treibt uns an - mittlerweile weltweit, denn wir sind Lidl. Hier ist das berufliche Zuhause vielfältiger Talente. Ob im Einkauf, in der Logistik, im Warengeschäft oder in der IT; ob als Impulsgeber, Gestalter oder Dienstleister der Länder. Wir suchen Anpacker, Durchstarter, Möglichmacher und bieten spannende Aufgaben und Projekte in einem dynamischen und internationalen Umfeld. Bei Lidl findet jeder seine persönliche Herausforderung. Denn Lidl lohnt sich.Deine AufgabenUnterstützung unseres Beraterteams für die Dauer von 5 bis 6 Monaten in strategischen Projekten über alle Phasen hinweg - von der Analyse, über die Konzeptentwicklung bis zur UmsetzungEinblicke in die Vorbereitung von und Teilnahme an Workshops zur Konzeptentwicklung und Optimierung Lidl-interner ProzesseEnge Zusammenarbeit mit verschiedenen Fachbereichen zu ausgewählten Beratungsprojekten und Unterstützung bei der Vorbereitung von Entscheidungsterminen mit dem Top-ManagementEinbringen bei der Erarbeitung strategischer Fragestellungen unter Berücksichtigung zukünftiger Trends und ZieleKennenlernen von Tools und Methoden der BeratungsarbeitDein ProfilMasterstudium oder fortgeschrittenes Bachelorstudium der WirtschaftswissenschaftenIdealerweise erste Praktika/Projektarbeiten in einer Management-BeratungAusgeprägte Kommunikationsfähigkeit und TeamfähigkeitPraktische Erfahrungen in den Themen Agile & Lean wünschenswertAnwendungssichere MS Office Kenntnisse, insbesondere in Excel und PowerPointErste Erfahrungen in der Workshop-Gestaltung wünschenswertSehr gute DeutschkenntnisseWir bietenLidl legt Wert darauf, dass sich deine Zeit bei uns lohnt! Deshalb kannst du bei uns nicht nur deine Finanzen aufbessern: Du gewinnst wertvolle Praxiseinblicke in „deinen“ Fachbereich und lernst die Herausforderungen im Tagesgeschäft kennen. Dabei steht dir nicht nur während der Einarbeitung ein fester Ansprechpartner zur Seite. Du hast zu jeder Zeit Zugriff auf das Expertenwissen deines festen Ansprechpartners und das Know-how deiner hilfsbereiten Kolleginnen und Kollegen. Lerne das kollegiale Umfeld und deine beruflichen Möglichkeiten bei Lidl kennen. Und nutze die Chance, dir ein erstes Karrierenetzwerk aufzubauen.

EinleitungEine gute Idee war der Ursprung, ein erfolgreiches Konzept ist das Ergebnis. Qualität zum guten Preis möglichst vielen Menschen anbieten zu können treibt uns an - mittlerweile weltweit, denn wir sind Lidl. Hier ist das berufliche Zuhause vielfältiger Talente. Ob im Einkauf, in der Logistik, im Warengeschäft oder in der IT; ob als Impulsgeber, Gestalter oder Dienstleister der Länder. Wir suchen Anpacker, Durchstarter, Möglichmacher und bieten spannende Aufgaben und Projekte in einem dynamischen und internationalen Umfeld. Bei Lidl findet jeder seine persönliche Herausforderung. Denn Lidl lohnt sich.Deine AufgabenUnterstützung unseres Beraterteams für die Dauer von 5 bis 6 Monaten in strategischen Projekten über alle Phasen hinweg - von der Analyse, über die Konzeptentwicklung bis zur UmsetzungEinblicke in die Vorbereitung von und Teilnahme an Workshops zur Konzeptentwicklung und Optimierung Lidl-interner ProzesseEnge Zusammenarbeit mit verschiedenen Fachbereichen zu ausgewählten Beratungsprojekten und Unterstützung bei der Vorbereitung von Entscheidungsterminen mit dem Top-ManagementEinbringen bei der Erarbeitung strategischer Fragestellungen unter Berücksichtigung zukünftiger Trends und ZieleKennenlernen von Tools und Methoden der BeratungsarbeitDein ProfilMasterstudium oder fortgeschrittenes Bachelorstudium der WirtschaftswissenschaftenIdealerweise erste Praktika/Projektarbeiten in einer Management-BeratungAusgeprägte Kommunikationsfähigkeit und TeamfähigkeitPraktische Erfahrungen in den Themen Agile & Lean wünschenswertAnwendungssichere MS Office Kenntnisse, insbesondere in Excel und PowerPointErste Erfahrungen in der Workshop-Gestaltung wünschenswertSehr gute DeutschkenntnisseWir bietenLidl legt Wert darauf, dass sich deine Zeit bei uns lohnt! Deshalb kannst du bei uns nicht nur deine Finanzen aufbessern: Du gewinnst wertvolle Praxiseinblicke in „deinen“ Fachbereich und lernst die Herausforderungen im Tagesgeschäft kennen. Dabei steht dir nicht nur während der Einarbeitung ein fester Ansprechpartner zur Seite. Du hast zu jeder Zeit Zugriff auf das Expertenwissen deines festen Ansprechpartners und das Know-how deiner hilfsbereiten Kolleginnen und Kollegen. Lerne das kollegiale Umfeld und deine beruflichen Möglichkeiten bei Lidl kennen. Und nutze die Chance, dir ein erstes Karrierenetzwerk aufzubauen.