Medical Writer II, Clinical/Regulatory
- Therapy areas
- Endocrinology and metabolism, Rare disease
- Writing types
- Regulatory
About the role
Responsibilities
- Develop scientifically accurate, regulatory-compliant documents for clinical trials, regulatory submissions and medical affairs
- Serve as medical writing lead on assigned projects and work with in-function and cross-functional teams on strategy
- Coordinate review, approval and production activities for writing projects
- Negotiate with functional areas on project outcomes and deliverables
- Identify and propose solutions to issues arising during the writing process
- Arrange and conduct review meetings with the team and ensure required documentation is obtained
About the Company
- Rezolute is a late-stage rare disease company focused on hypoglycemia caused by hyperinsulinism, developing the antibody therapy RZ358 (ersodetug).
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