For our client, a company in the pharma sector, we are looking for a motivated personality in Basel in the position of:
Patient Access Program and Supply Lead
As part of PDMA, the Product Development department oversees patient access programs and ensures supply for them. This is a similar opening to previous Compassionate Use Coordinator & Post Trial Access Coordinator.
- The objectives and scope of the positions are as follows:
- Actively plan and implement the Roche Patient Access Programs (PAP) managed in PDMA such as Pre-Approval Access &Compassionate Use (PAA/CU) programs and Post-Trial Access (PTA) programs described as per processes and regulations
- Ensure that all activities in the Community of Practice for PAA/CU, PTA and Drug Supply are handled according to internal standards and relevant regulatory and legal compliance standards
- Ensure adequate material and budget planning and effective delivery of Clinical Drug Supply for the conduct of managed global and local clinical trials & PAP (PDG-MA, IIS, FMI, PTA and PAA/CU)
- Track and document all PAP & supply requests
- Facilitate and improve internal PAP and supply processes and support shaping of PAP policy
- Liaise with, support and maintain strong relationships with all involved stakeholders and collaboration partners (gRED, pRED, GPS, PD(G), PDMA, PA, PT, Quality and Finance, external vendors, IT)
The perfect candidate is someone with previous strong project management experience in pharma (preferably in clinical trials) and excellent understanding of Health Authorities' expectations (ICH/GCP). The soft skills are really important for this position, we need someone proactive and self-managed, able to adapt and be flexible to an evolving matrix environment.
Tasks & Responsibilities
- Takes the lead in projects and programs: manages project and budget management activities (develops work plans, coordinates project on day-to-day basis, tracks deliverables / milestones, facilitates clear communication between all team members and stakeholders, provides status updates, ensures adherence to high quality of deliverables)
- Jointly develops working practices and processes related to PAPs, and maintains them up-to date, identifying and aligning strategic and operational aspects (e.g. decision-making, systems, roles & responsibilities)
- Proactively incorporates learnings and recommendations from other programs; identifies needs for process standardization, regulatory compliance direction and areas for improvement
- Continuously updates key process documents, incl. SOPs, supporting documents for the development of PAP procedures.
- Establishes, maintains and fosters strong effective relationships with key stakeholders such medical colleagues in PD(MA), CoP members in MAO, GPS, Technical/Clinical Drug Supply colleagues, Quality, PV, Finance and affiliate team and vendors.
- Ensures an efficient, effective and compliant PAP and Drug Supply management with documentation and reporting/metrics in PAIRS and other databases as required:
- Ensures receipt, filing and tracking of PAP records (SDEAs, Physician's Agreement, Regulatory Forms, other country specific documents) in the required quality in PAIRS.
- Identifies and adapts PAIRS system to the needs of the various customer groups and ensuring compliance. Manages Affiliate sharepoints (filing area, affiliate area) and RecPoint (records) program area according to global standards, including set up, access rights and maintenance of program related documents;
- Manages timely interaction between clinical program and the Clinical Demand and Supply Leads in Pharma Technical in order to ensure proper preparation and delivery of the drug supply.
- Consolidates and monitors clinical drug supply planning for managed global and local clinical trials & programs
- Ensures clinical drug supply budget forecasting and tracking for assigned Therapeutic Areas.
- Acts as IXRS implementation coordinator.
- Identifies proactively potential delivery issues and risks and ensures corrective and preventive actions (CAPAs) in case of deviation, communicates to stakeholders.
- Supports the CoPLs in PDMA MAO to ensure PDMA representation in cross-functional / departmental initiatives related to patient access to drug.
- Min 5 years' experience in pharma / clinical research (preferably in clinical trials)
- Previous project / program management experience in pharma in international clinical trials setting
- Experience and understanding of global expectations of Health Authorities and overall healthcare environment (ICH/GCP)
- Experience in multicultural & cross functional environment
- Soft skills are highly important here and will be evaluated during the interview stage: excellent communication skills, collaborative, pro-active and flexible mindset.
Start date: ASAP
End date: 1 year duration
Remote/Home Office: Flexible between onsite and home office.
Team: About 15 people
Department: PDMA Medical Alliances Operations (MAO)
Please apply online. For further information about the position, please contact your Kelly recruiter, Franck Maerky (+41 61 270 80 17).