Patient Access Program and Supply Lead
A multinational health company is looking for a talented and experienced individual to join their team as a Patient Access Program and Supply Lead. This is one of the largest pharmaceutical organisations across the globe, this is an excellent opportunity to be amongst the most talented scienfitical minds - giving you unprecented access to growth and development.
- 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.
Skills and Requirements
* 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.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.