Main Purpose of the Role :
The Experienced Medical Affairs Professional is an individual contributor who operates under limited supervision, applying specialized subject matter knowledge to support clinical research, regulatory compliance, and medical strategy initiatives.
This role requires the ability to apply expertise effectively to meet specific project or organizational needs.
Key Responsibilities :
- Lead and oversee planning, execution, and management of clinical trials and research activities.
- Contribute to the implementation of clinical protocols and ensure timely completion of final reports.
- Recruit and collaborate with clinical investigators, negotiating study design and costs.
- Direct human clinical trials (Phase III & IV) for company products under development.
- Monitor adherence to clinical protocols and determine study completion.
- Participate in adverse event reporting and ensure compliance with safety monitoring responsibilities.
- Coordinate reporting and provide data for submissions to regulatory agencies.
- Oversee investigator initiations, group studies, and cross-functional project coordination.
- Act as a consultant or liaison with external organizations under licensing or collaboration agreements, as Relevant advanced degree in a medical, clinical, or life sciences field.
- Demonstrated experience in clinical trials, medical affairs, or related areas.
- Strong knowledge of regulatory requirements, safety monitoring, and clinical research processes
(ref : iimjobs.com)