Global Medical Strategy Lead
2 days ago
The Global Medical Strategy Lead will provide medical strategic input for deliverables in assigned projects/programs and oversee medical and scientific review of trial data.
This role involves:
- Providing clinical leadership and medical strategic input for deliverables in assigned projects/programs.
- Delivering clinical components of regulatory documents/registration dossiers, and publications (e.g., IBs, Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities).
- Supporting SR/GPCH in ensuring overall safety of the molecule and contributing to program safety reporting (e.g., PSURs, DSURs, and safety related documents) in collaboration with Patient Safety.
A strong understanding of the therapeutic area, GCP, trial design, statistical analysis methodology, and regulatory/clinical development process is essential.
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