Rezolute

Medical Writer II, Clinical/Regulatory

Redwood City Full-time On-site
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Job Description

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.

Frequently Asked Questions

What does the Medical Writer II, Clinical/Regulatory role at Rezolute involve?

The Medical Writer II, Clinical/Regulatory position at Rezolute in Redwood City is a full-time role. 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.

What skills are required for Medical Writer II, Clinical/Regulatory at Rezolute?

Please refer to the full job description for required skills and qualifications.

What is the salary for Medical Writer II, Clinical/Regulatory at Rezolute?

The salary for this position is not publicly listed. You can negotiate during the interview process. Check Glassdoor or Levels.fyi for estimates.

Is the Medical Writer II, Clinical/Regulatory position at Rezolute remote or on-site?

This position is On-site. The role is based in Redwood City.

How do I apply for Medical Writer II, Clinical/Regulatory at Rezolute?

You can apply for this position directly through the employer's careers page. Click the 'Apply Now' button on this page to be redirected to the original listing. Make sure your resume is ATS-optimized. Use SpotChange's free ATS test to check.

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About This Role

Medical Writer II, Clinical/Regulatory at Rezolute is a full-time other position in Redwood City. Education: Master's Degree preferred. Experience: 3+ years.

This role is classified as on-site and is suitable for mid level-level professionals. Ghost Score 20/100 (Probably Active) indicates this listing is probably active with recent employer engagement.

To apply, visit the official application page through the Apply Now button above. SpotChange Jobs provides AI-powered career tools including resume optimization, ATS testing, interview preparation, and salary negotiation assistance.