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Clinical Project Specialist
2 months ago
Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.
We are currently seeking a Medical Information Specialist (MIS) on an initial 12-month FTC (maternity cover) to join our team. This exciting role is ideal for individuals with previous experience working in a busy pharmaceutical medical information (MI) team or department, looking to further their career by assisting in the growth and overall management of a highly skilled MI team.
Key Responsibilities:- Manage MI enquiries in a timely manner for Clinigen products and MI enquiries for other Pharmaceutical Client products, where Clinigen is contracted to provide MI support, ensuring all pertinent regulations and processes are adhered to.
- Ensure all patient safety issues and product quality complaints are escalated appropriately and in line with standard operating procedures.
- Perform reconciliation activities of received medical Information enquiries, product complaints and adverse events with other internal and/or external stakeholders as required.
- Stay up to date with EFPIA and UK ABPI Code of Practice and share best practice with product and medical teams.
- Review of promotional materials ensuring that scientific and medical data are quoted accurately, that references are appropriate, current and accurately cited.
- Contribute to quality related activities including change control management, CAPA (Corrective and Preventative Action) and deviation management.
- Represent medical information in internal and external audits and inspections, as required.
- Demonstrable experience in Medical Information in the Pharmaceutical Industry with an awareness of the ABPI Code of Practice.
- Patient and customer insight through experience in the pharmaceutical industry.
- Qualified up to BSc or equivalent life science degree and preferably a UK Registered Pharmacist.
- 27 days holiday plus 8 bank holidays.
- Pension contributions.
- Life assurance.
- Flexible Benefits Platform with £25/month Company contribution.
- Annual salary review.
- Independent financial advice service.
- Enhanced Employee Assistance Programme.
- Shopping discounts with retailers.
- Long service awards.
- Recognition scheme & employee of the year awards.
