Medical Writer II, Clinical/Regulatory

Location: Redwood City, California  

Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI).

 

We are seeking an experienced and detail-oriented Medical Writer II to join our dynamic team. In this role, you will be responsible for developing high-quality, scientifically accurate, and regulatory-compliant documents for clinical trials, regulatory submissions and medical affairs. Interfaces with cross-functional groups to ensure accurate and timely completion/delivery of information and review of writing projects. You will collaborate with cross-functional teams, including clinical researchers, regulatory professionals, and subject matter experts, to produce materials that support the advancement of clinical trials, product development, and regulatory submissions.

 

The Medical Writer II serves as medical writing lead on assigned projects. Works closely with in-function and cross-functional team(s) on project strategies. Implements all activities related to the preparation of writing projects. Coordinates the review, approval, and other appropriate functions involved in the production of writing projects. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate.  Arranges and conducts review meetings with the team. Ensures required documentation is obtained.