Post-Trial Access Coordinator - PHARMA
An excellent multinational healthcare company is seeking a Post-Trial Access Coordinator to be based in their office in the desirable area of Basel. The organisation is known internationally for their work in pharmaceuticals and diagnostics and their focus on scientific advancement. This is a chance to join a top healthcare organisation who provide an innovative range of diagnostic solutions and medicines.
- Actively support the implementation of the company Post-Trial Access programs (PTAPs) described as per company processes and regulations
- Ensure that all activities in relation to PTAPs are handled according to internal standards and relevant regulatory compliance standards.
- Track and document all PTAP requests.
- Facilitate and improve internal PTAP processes.
- Liaise with and support all involved stakeholders and collaboration partners (gRED, pRED, GPS, PD, PDMA, PA, PT).
- Establishes, maintains and fosters strong relationships with key stakeholders and ensures an efficient, effective and compliant PTA management.
- Develops and maintains effective working relationships with (G)IMDs, PTA team members, affiliate teams and vendors.
- Ensures receipt, filing and tracking of PTA records (SDEAs, Physician's Agreements, Regulatory Forms, other country-specific documents) in the required quality.
- Manages timely interaction between relative CLinOps colleagues in PDMA (ICTMs/ICPL) or PDG (GSLs/OPLs) and the Clinical Drug Supply Leads in Pharma Technical in order to ensure proper preparation and delivery of the PTAP drug supply.
- Serves as the SME for the development of procedures for Continued Access/PTAPs, supports development of the working practices and processes related to PTAPs, and maintains them up-to-date.
- Manages Touchpoint (filing area, affiliate area) and RecPoint (records) program area according to global standards, including set up, access rights and maintenance of program related documents.
- Keeps the PTA Program Database up-to-date and provides regular reports to Senior Management, incl preparation of metrics.
- Identifies proactively potential delivery issues and risks and ensures corrective actions in case of deviation, communicates to stakeholders.
- Responsible for project management, tracking of milestones and timelines, and timely data entry in MDMS/CTMS.
- Proactively incorporates leanings and recommendations from other programs; identifies needs for process standardisation, regulatory compliance direction and areas for improvement.
- Supports the PDMA, Head Drug Supply Compassionate Use to ensure PDMA representation in cross functional/ departmental initiatives related to access to drug.
- Responsible for acting in line with legal, regulatory and company standards and codes of practice (eg. Company's Code of Conduct, applicable company directives, guidelines and SOPs).
- Completes all required training modules as a priority.
Skills and Requirements
- Minimum of 5 year's professional experience in the pharmaceutical /clinical research industry, preferably in clinical development.
- Life sciences degree or nursing degree.
- Postgraduate degree in life sciences, medical or equivalent area.
- High ethical standards.
- Demonstrate company values and core competencies.
- Strong collaboration and teamwork skills, including the ability to work across the organisation at all levels and achieve results within a multi-cultural team.
- Excellent communication skills.
- Excellent analytical /problem-solving skills.
- Ability to achieve win-win situations in a complex environment with key stakeholders.
- Strong project management, organisational and operational skills.
- Forward-thinking and creative solution development.
- Proactivity and high evel of commitment.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Anna Bigiotti at +44 2038542470 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.