Beschreibung
Patient Access Program and Supply Lead (f/m/d)- ICH-GCP / Clinical trials experience / Project - Program Management / Stakeholder Management / EnglishProject:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Patient Access Program and Supply Lead
Background:
As part of PDMA (Global Medical Affairs) MAO (Medical Alliances Operations) this Community of Practice (CoP) oversees patient access programs and ensures supply for them. The objectives and scope of the positions are as follows:
Actively plan and implement the 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
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
The perfect candidate is someone with either experience in patient access programs or 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 flat 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, Global Product Strategy (GPS), Technical/Clinical Drug Supply colleagues, Quality, Pharmacovigilance (PV), Finance and affiliate team and vendors.
- Ensures an efficient, effective and compliant PAP and Drug Supply management with documentation and reporting/metrics in the Patient Access Integrated Registry & Supply (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.
Must Haves:
- Min 5 years' experience in pharma / clinical research (preferably in clinical trials)
- Previous project / program management experience in pharma in international clinical trials setting (based on organization and operational skills)
- 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 and problem solving skills, collaborative and leadership ability, proactive and flexible mindset.
Reference Nr.: 921925SGR
Role:Patient Access Program and Supply Lead
Industrie:Pharma
Workplace:Basel
Pensum: 100%
Start: 01.11.2022
Duration: 12++
Deadline: 13.09.2022
If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
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About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.