GQR is hiring: Senior Manager Medical Writing 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

• Bachelor’s degree in life sciences required; advanced degree (MS, PhD, PharmD) strongly preferred.
• Minimum of 8 years’ direct medical writing experience in the biopharmaceutical industry or CROs, with at least 3 years in oncology drug development.
• Proven ability to produce clear, concise, and high-quality documents in English, covering a broad range of clinical and regulatory submissions.
• Demonstrated experience with protocols, IBs, DSURs, CSRs, and IND/NDA/MAA CTD modules.
• Strong project management and facilitation skills, with a track record of leading complex projects in a fast-paced, matrixed environment.
• Ability to influence without authority, encourage cross-functional collaboration, and manage competing priorities.
• Familiarity with document development tools, automation, and processes that accelerate high-quality output.
• Strong technical and statistical literacy, with the ability to interpret and communicate complex clinical data.
• Excellent written and verbal communication skills, including the ability to present ideas and findings to senior stakeholders.

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Writing/Editing

Industries

• Biotechnology Research and Pharmaceutical Manufacturing