Senior Project Manager (French Speaking - Early Access)

Job description

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: **France 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 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. **Operational Delivery & Project Management** - 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. **Business Development & Commercial Growth** - 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. **Team Leadership & Stakeholder Management** - 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. ### What You'll Need: **Essential** - 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 **Desirable** - 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