Senior Manager Medical Writing Job at GQR in California

3 days ago Be among the first 25 applicants

This range is provided by GQR. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$110.00 / hr - $125.00 / hr

Position Summary

We are seeking a highly motivated and experienced Medical Writing professional to join our team as a Senior Manager or Principal Medical Writer (contractor). In this role, you will be responsible for developing high-quality clinical and regulatory documents in collaboration with internal stakeholders and external partners. The ideal candidate brings deep expertise in oncology, strong project leadership skills, and the ability to deliver clear, accurate, and impactful documents that support regulatory submissions and clinical development programs.

Key Responsibilities

• Lead the authoring and preparation of clinical and regulatory documents (e.g., study protocols, investigator brochures [IBs], DSURs / safety updates, clinical study reports, IND / NDA / MAA CTD submission documents, briefing packages, and responses to health authority questions).
• Ensure documents meet regulatory requirements, global standards, and company SOPs.
• Partner with functional leads to plan document content, establish timelines, and drive project execution.
• Provide scientific writing expertise to ensure clarity, consistency, formatting, and accuracy across programs and clinical dossiers.
• Facilitate and lead document adjudication meetings; resolve issues with cross-functional contributors.
• Oversee review and approval processes, including coordination with development partners and external collaborators.
• Work independently and effectively across geographically and culturally diverse teams, fostering collaboration, openness, and trust.

Qualifications

Seniority level

Employment type

Job function

Industries

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