Document Writer
2 days ago
We are seeking a skilled writer to create high-quality clinical and safety documentation for regulatory submissions. The ideal candidate will have experience in medical writing, regulatory affairs, and excellent communication skills.
This role requires strong knowledge of the global regulatory environment, including key documents, approval processes, and safety reporting requirements.
Main Responsibilities- Write and review clinical and safety documents, including non-registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), and Risk Management Plans (RMP).
- Lead outsourced narrative projects and coordinate other outsourced activities in RWS.
- Participate in the Clinical Trial Team (CTT) and Safety Management Team (SMT), ensuring compliance with internal company standards and external regulatory guidelines.
- Minimum university life science degree or equivalent.
- Medical writing experience or relevant pharma industry experience combined with scientific and regulatory knowledge.
- Excellent communication skills, including written, verbal, and presentation skills.
- Advanced degree or equivalent education/degree in life sciences/healthcare.
- Proven track record in matrix environments and experience contributing to global, cross-functional projects.
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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