Principal Medical Writer - Regulatory and Medical Writing

Role Summary

The Principal Medical Writer will collaboratively lead, write, and manage delivery of clinical regulatory documents. This individual contributor role reports to the Executive Director (Head) of Regulatory and Medical Writing and covers the full lifecycle of documents, including cross-functional data interpretation, key messaging, regulatory-compliant content, QC reviews, QA audit resolution, and coordination with Regulatory Operations for publishing and submissions. Preference given to San Diego-based applicants; remote work possible.

Responsibilities

• Collaborate with internal teams to lead, write, and manage complex clinical regulatory documents (e.g., clinical study reports, Investigator Brochures, clinical study protocols, briefing documents, Module 2 marketing application summaries).
• Serve as Medical Writing department lead on multiple project/core teams.
• Function as subject matter expert within the department for assigned therapeutic/product areas.
• Plan and lead cross-functional teams to meet deliverable timelines (in collaboration with Global Project Management).
• Lead key messaging and storyboard sessions to ensure clarity and consistency across documents.
• Interpret sources of information with appropriate guidance.
• Ensure compliance with conventions, grammar, formatting, and hyperlinking as needed.
• Manage review cycles; lead data interpretation and comment-resolution meetings.
• Perform QC reviews and interact with QA to resolve audit findings.
• Maintain expert knowledge of US and international regulations and guidance for regulatory documentation.
• Coordinate with Regulatory Operations to ensure on-time preparation and publication of submission documents.
• Support Global Regulatory Lead with information/responses requested by regulatory agencies.
• Mentor junior writers as needed.
• Other duties as assigned.

Qualifications

• Bachelor‚Äôs Degree required; advanced degree in a relevant field a plus.
• Minimum 8 years of direct experience as a medical writer preparing regulated documents in the pharmaceutical industry; marketing application experience required (e.g., lead writer of Module 2.5, 2.7.3, or 2.7.4); rare disease experience a plus.
• Experience as lead writer for major US/international regulatory submissions (clinical study reports, Investigator Brochures, clinical study protocols, marketing application summaries, INDs, NDAs, briefing documents, etc.).
• In-depth experience writing Safety sections of regulatory documents preferred.
• Ability to independently complete documents to completion.
• Extensive knowledge of FDA, EMA, and ICH guidelines, especially ICH E3 and ICH E6.
• Experience mentoring junior writers a plus.
• Strong understanding of the drug development process; ability to assimilate and interpret scientific data; experience preparing data tables and basic figures.
• Proficient in AMA style guidelines; strong editing skills for spelling, punctuation, grammar, clarity, and accuracy.
• Excellent attention to detail and time-management; ability to manage multiple projects.
• Technical proficiency with Microsoft Office, Adobe Acrobat; experience with Veeva and StartingPoint templates a plus.
• Ability to follow style guides, lexicons, and eCTD templates; excellent written and spoken communication.
• Energetic, self-motivated, collaborative, and able to thrive in a dynamic environment.
• Team-oriented with a strong work ethic and the ability to work in an intense environment.

Skills

• Regulatory writing and project leadership
• Data interpretation and scientific storytelling
• Cross-functional collaboration
• Regulatory guidelines (FDA/EMA/ICH) and eCTD technical standards
• Document quality control and QA interaction
• Mentoring and leadership of junior writers

Education

• Bachelor‚Äôs Degree required; advanced degree in a relevant scientific/clinical/regulatory field a plus

Additional Requirements

• Remote work possible; preference for San Diego-based candidates