As a Medical Affairs Specialist, you will assist the Medical Affairs Director in ensuring operational excellence. Your responsibilities will include creating and training on OPTW Medical SOPs, demonstrating meaningful protocol knowledge, ensuring CSRs are performed according to GCP guidelines for Phase IV studies, communicating accurate medical/scientific information, minimising risks that violate local laws, recognising potential CSR budget issues, and maintaining accurate medical information documents.
What you'll do:
As a Medical Affairs Specialist, you will play a crucial role in maintaining high medical standards and compliance in the field. You will assist the Medical Affairs Director in ensuring operational excellence. Your responsibilities will include creating and training on OPTW Medical SOPs, demonstrating meaningful protocol knowledge, ensuring CSRs are performed according to GCP guidelines fo phase IV studies, communicating accurate medical/scientific information, minimising risks that violate local laws, recognising potential CSR budget issues, and maintaining accurate medical information documents.
- Creation and training of OPTW Medical SOPs, policy and guidelines
- Demonstrating meaningful protocol and product knowledge of assigned CSRs in collaboration with therapeutic/disease area leads
- Ensuring CSRs performed by CRO are in accordance with Good Clinical Practice (GCP), guidelines, standards, regulations, and SOPs
- Communicating accurate medical/scientific information and safety information
- Minimising and preventing from the underlying risk that violates local law and regulations
- Recognising potential issues relevant for CSR budget and govern the expenditure of outsourced CRO
- Maintaining medical information documents by ensuring that responses are medically and scientifically accurate and meet customer's need
What you bring:
The ideal candidate for the Medical Affairs Specialist role will bring a strong understanding of medical governance requirements, experience in supporting company-sponsored research, and the ability to communicate complex medical/scientific information clearly. You should have a solid knowledge of Good Clinical Practice (GCP) guidelines, experience in managing CSR budgets, and the ability to maintain accurate medical information documents. Your commitment to maintaining high medical standards will be key to your success in this role.
- Strong understanding of medical governance requirements
- Experience in providing support for company-sponsored research
- Ability to communicate complex medical/scientific information clearly
- Knowledge of Good Clinical Practice (GCP) guidelines
- Experience in managing CSR budgets
- Ability to maintain accurate medical information documents
What sets this company apart:
Our client is a leading player in the pharmaceutical industry with a reputation for excellence. They are committed to providing a supportive and inclusive work environment where employees can grow and thrive. They offer flexible working opportunities, generous pensions contributions, and training opportunities to ensure their team members are always at the forefront of industry developments.
What's next:
If you're ready to take your career to the next level with a role that offers challenge and growth, apply today!
