Senior Project Manager (French Speaking - Early Access)

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.

Responsibilities

Lead the strategic development of the France Early Access service line, including service design, operational delivery models and growth planning; Serve as subject matter expert on French early access pathways, providing guidance on feasibility, timelines, and regulatory risk; Lead internal management of CEPS Rebates and URSSAF Montant M tax payment cycles; Coordinate and lead the development of Periodic Reports aligned with ANSM/HAS requirements; Build and maintain relationships with strategic partners in France; Lead end-to-end setup and delivery of France Early Access programs, including planning, timelines, budget oversight, and risk mitigation; Ensure programs comply with WEP Clinical SOPs, ICH GCP, GDPR, and French data privacy and pharmacovigilance requirements; Oversee study documentation, including Therapeutic Use Protocols (PUT-SP and PUT-RD), site agreements, and eTMF records; Manage out-of-scope identification and change orders with Business Development; Monitor program budgets and resource allocation; Identify, evaluate, and mitigate risks to project quality, timeline, or client satisfaction; Proactively identify and pursue new France Early Access business opportunities; Represent WEP Clinical at French industry conferences, client meetings, and regulatory forums; Develop and maintain a pipeline of prospective clients in pharmaceutical and biotechnology companies; Build and maintain client relationships as primary point of contact for France Early Access programs; Collaborate with cross-functional teams to ensure seamless program delivery; Provide training and guidance to internal teams on French regulatory requirements; Mentor and support junior staff assigned to France Early Access programs

Requirements

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); 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

Nice to have

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

Benefits

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