Senior Project Manager (French Speaking - Early Access)

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.Role ObjectivesThe WEP Clinical Senior Project Manager (France Early Access) is responsible for leading, establishing, and managing WEP Clinical's France Early Access service offering, including both operational delivery and business development for named patient programs and expanded access programs within the French market.This role combines deep Market Access expertise with project management discipline to ensure compliant, commercially viable, and operationally excellent early access programs in France.The Ideal CandidateTeam PlayerAdaptableDetail OrientedProblem SolverWhat You'll DoFrance Market Access & Regulatory Strategy Lead the strategic development of WEP Clinical's France Early Access service line, including service design, operational delivery models and growth planning.Maintain current, in-depth knowledge of French regulatory frameworks governing early access, including:Autorisation d'Accès Précoce (AAP) – Early Access AuthorisationAutorisation d'Accès Compassionnel (AAC) – Compassionate Access AuthorisationAgence Nationale de Sécurité du Médicament et des Produits de Santé – The French National Agency for Medicines and Health Products Safety (ANSM) requirements and submission processesHaute Autorité de Santé – the French National Authority for Health (HAS) requirements and submission processesServe as the subject matter expert on French early access pathways, providing internal and client-facing guidance on feasibility, timelines, and regulatory risk.Lead the internal management of CEPS Rebates and URSSAF Montant M tax payment cycles managing calculation, reconciliation, and client communication to ensure full compliance with annual reporting timelines.Coordinate and lead the development of Periodic Reports ensuring alignment with ANSM/HAS requirements and client expectations, while managing stakeholder inputs and final submissions.Build and maintain relationships with strategic partners in France to ensure compliant and high-quality program delivery, serving as the primary point of contact for partner performance and issue resolution.Operational Delivery & Project ManagementLead end-to-end setup and delivery of France Early Access programs, including project planning, timeline management, budget oversight, and risk mitigation.Ensure all programs comply with WEP Clinical SOPs, ICH GCP guidelines, GDPR, and French-specific data privacy and pharmacovigilance requirements.Oversee the preparation and maintenance of study documentation, including Therapeutic Use Protocols (PUT-SP and PUT-RD), site agreements, and electronic Trial Master File (eTMF) records.Manage out-of-scope (OOS) identification and change orders, collaborating with Business Development to ensure commercial viability of program expansions.Monitor program budgets and resource allocation, ensuring profitability targets are met while maintaining high-quality service delivery.Identify, evaluate, and mitigate risks to project quality, timeline, or client satisfaction, communicating proactively to internal stakeholders and clients.Business Development & Commercial GrowthProactively identify and pursue new France Early Access business opportunities, including client pitches, proposal development, and bid defense meetings.Represent WEP Clinical at French industry conferences, client meetings, and regulatory forums to promote the company's France Early Access capabilities.Work with Business Development to develop competitive pricing and service models tailored to the French market.Develop and maintain a pipeline of prospective clients, including pharmaceutical and biotechnology companies seeking early access solutions in France.Team Leadership & Stakeholder ManagementBuild and maintain strong, positive client relationships, acting as the primary point of contact for clients of France Early Access programs throughout the program lifecycle.Collaborate with cross-functional teams (Regulatory, Medical Affairs, Data Management Clinical Operations, Business Development, Market Access and Legal) to ensure seamless program delivery.Provide training and guidance to internal teams on French regulatory requirements, early access pathways, and cultural/nuanced operational considerations in France.Mentor and support junior staff assigned to France Early Access programs, ensuring they understand French-specific compliance and operational standards.EssentialWhat You'll Need:Bachelor's Degree (health, life sciences, or pharmacy preferred)Significant experience in Market Access, Medical Affairs, or Early Access Programs, with specific exposure to the French pharmaceutical regulatory environmentDemonstrated ability to lead early access or named patient programs from feasibility through to close-outFluency in French and English (written and spoken) – essential for regulatory communication and client engagement in FranceStrong knowledge of key external stakeholder (ANSM/CEPS/URSSAF) processes and French early access legislationExperience working in a CRO, pharmaceutical company, or consultancy with a focus on European early access marketsComputer literacy, including proficiency in Microsoft Office and experience with eTMF and CTMS platformsStrong organisational, communication, and interpersonal skillsAbility to manage multiple priorities and work independently in a fast-paced, client-facing environmentWorking knowledge of ICH GCP guidelines, GDPR, and pharmacovigilance requirementsDesirablePostgraduate qualification in Market Access, Public Health, or Health EconomicsExisting network of French KOLs, ANSM contacts, or pharmaceutical industry decision-makersExperience developing new service lines or commercial offerings within a CRO environmentLine management experience or demonstrated ability to mentor and develop junior staffWhat We OfferGroup Private Medical InsuranceGroup General Life AssuranceGroup Critical Illness and Group Income ProtectionSalary sacrifice pension schemeEnhanced maternity & paternity payEducational Assistance allowancePaid volunteering dayWhat Sets Us ApartWEP Clinical partners with biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most. Through end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy, we provide flexible, fit-for-purpose solutions that support drug development, improve access, and help therapies reach the right patients at the right time. With more than 15 years of global experience, we have supported programs across 150+ countries, combining operational scale with the agility and personalised service of a specialised provider. Our work helps bridge critical gaps in care, ensuring safe, ethical, and efficient access to promising new treatments.We're Committed To Our TeamWEP has many initiatives to encourage wellness, growth, development, and team relationships. Check out our LinkedIn life page to learn more about our team events and all that we do to support our employees.How We Work At WEP ClinicalAt WEP Clinical, we look for individuals who are conscientious, exercise sound judgement, and engage with others thoughtfully and professionally. We believe excellence is achieved through integrity, accountability, and respect for diverse perspectives – and we are committed to helping our people grow and succeed in an inclusive, supportive environment.Our Services IncludeAccess ProgramsClinical Trial ServicesPatient Site SolutionsClinical Trial SupplyMarket Access and CommercializationData Privacy NoticeWEP Clinical is committed to protecting your personal information throughout the recruitment process. By applying, you acknowledge that your personal data will be processed in accordance with our Privacy Policy and Job Applicant Privacy Notice.Privacy Policy: https://www.wepclinical.com/privacy-policy/Job Applicant Privacy Notice: https://www.wepclinical.com/Job-Applicant-Privacy-Notice/How To ApplyTo be considered for this role, please submit your resume through the WEP Clinical Careers Portal or by using LinkedIn’s Easy Apply option. Please ensure your resume is in English.Important NoteTo streamline our hiring process, we use an Upwage AI screener. If you receive a link from Upwage, it is a legitimate part of our application process and helps ensure every candidate is reviewed consistently. If you are selected to move forward after the screener, a member of our team will contact you directly from an @wepclinical.com email address to guide you through the next steps of the interview process. Please ensure you apply only through our official careers page (https://www.wepclinical.com/careers/) or our verified LinkedIn page.For Your Safety, Please NoteWe will never communicate with you via Microsoft Teams or text message.We will never ask for your bank account information at any stage of recruitment.WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. 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