Leads regional and global Post Approval Named Patient Programs and related clinical research projects, managing timelines, budgets, teams, client relationships, risks, training, quality, documentation, and regulatory compliance. Oversees eTMF and CTMS activities, site operations, payments, SOP adherence, change orders, and project delivery. Requires French fluency, clinical research or PA-NPP experience, knowledge of ICH GCP and clinical development, strong organizational and communication skills, and proficiency with Microsoft Office and clinical systems.
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 Objectives:
The 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 Candidate:
- Team Player
- Adaptable
- Detail Oriented
- Problem Solver
What You'll Do:
- 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 Authorisation
- Autorisation d'Accès Compassionnel (AAC) – Compassionate Access Authorisation
- Agence Nationale de Sécurité du Médicament et des Produits de Santé – The French National Agency for Medicines and Health Products Safety (ANSM) requirements and submission processes
- Haute Autorité de Santé – the French National Authority for Health (HAS) requirements and submission processes
- Serve 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.
- Lead 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.
- Proactively 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.
- Build 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.
France Market Access & Regulatory Strategy
Operational Delivery & Project Management
Business Development & Commercial Growth
Team Leadership & Stakeholder Management
What 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 environment
- Demonstrated ability to lead early access or named patient programs from feasibility through to close-out
- Fluency in French and English (written and spoken) – essential for regulatory communication and client engagement in France
- Strong knowledge of key external stakeholder (ANSM/CEPS/URSSAF) processes and French early access legislation
- Experience working in a CRO, pharmaceutical company, or consultancy with a focus on European early access markets
- Computer literacy, including proficiency in Microsoft Office and experience with eTMF and CTMS platforms
- Strong organisational, communication, and interpersonal skills
- Ability to manage multiple priorities and work independently in a fast-paced, client-facing environment
- Working knowledge of ICH GCP guidelines, GDPR, and pharmacovigilance requirements
- Postgraduate qualification in Market Access, Public Health, or Health Economics
- Existing network of French KOLs, ANSM contacts, or pharmaceutical industry decision-makers
- Experience developing new service lines or commercial offerings within a CRO environment
- Line management experience or demonstrated ability to mentor and develop junior staff
Essential
Desirable
What We Offer:
Group Private Medical Insurance
Group General Life Assurance
Group Critical Illness and Group Income Protection
Salary sacrifice pension scheme
Enhanced maternity & paternity pay
Educational Assistance allowance
Paid volunteering day
What Sets Us Apart:
WEP 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 Team:
WEP 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 Clinical:
At 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 Include:
Access Programs
Clinical Trial Services
Patient Site Solutions
Clinical Trial Supply
Market Access and Commercialization
Data Privacy Notice:
WEP 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 Apply:
To 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 Note:
To 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 Note:
We 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.
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