Principal Medical Writer - Regulatory and Medical Writing

Role Summary

The Principal Medical Writer will collaborate with internal teams to lead, write, and manage completion of clinical regulatory documents. This individual contributor, reporting to the Executive Director (Head) of Regulatory and Medical Writing, oversees responsibilities throughout the lifecycle of a document, including cross-functional data interpretation, key messaging, compliance with US and international regulations, quality control, QA audit resolution, and publishing/submission support. The position may be fully remote, with a preference for San Diego-based applicants.

Responsibilities

• Working with the Executive Director, Regulatory and Medical Writing, collaborate with internal teams (e.g., Clinical Development and Biostatistics) to lead, write, and manage complex clinical regulatory documents (e.g., clinical study reports, Investigator Brochures, clinical study protocols, briefing documents, marketing application summary documents [Module 2], etc.).
• Serve as Medical Writing department lead on multiple project/core teams.
• Function as subject matter expert within the department for assigned therapeutic/product areas.
• Responsible for planning (in collaboration with Global Project Management) and leading cross-functional teams to meet timelines for deliverables.
• Lead complex scientific key messaging/storyboarding cross-functional meetings, ensuring the messages are clear and consistent within and across documents.
• Understand, assimilate, and interpret sources of information with appropriate guidance.
• Ensure compliance with appropriate conventions, proper grammar usage, and correct format requirements, as needed (e.g., formatting, hyperlinking).
• Manage review cycles for documents; schedule and lead data interpretation meetings, comment resolution meetings, and other document-related meetings.
• Perform quality control (QC) reviews as necessary.
• Interact with Quality Assurance (QA) to resolve audit findings for specific documents.
• Maintain expert knowledge of US and international regulations, requirements, and guidance associated with preparation of regulatory documentation.
• Effectively coordinate with Regulatory Operations to ensure on-time preparation and publication of regulatory submission documents.
• Support Global Regulatory Lead with preparing information/responses requested by regulatory agencies.
• Mentor junior writers as needed.
• Other duties as assigned.

Qualifications

• Bachelor’s Degree required; advanced degree in a relevant scientific/clinical/regulatory field a plus.
• A minimum of 8 years of direct experience as a medical writer preparing regulated documents in the pharmaceutical industry. Marketing application experience (e.g., lead writer of Module 2.5, 2.7.3, or 2.7.4) required. Rare disease experience is a plus.
• Experience as lead writer of key documents included in major US and/or international regulatory submissions (clinical study reports, Investigator Brochures, clinical study protocols, marketing application summary documents, INDs, NDAs, and other regulatory documents such as Briefing Documents).
• In-depth experience writing Safety sections of regulatory documents preferred.
• Ability to independently write and complete documents to completion.
• Extensive working knowledge of FDA, EMA, and ICH guidelines, particularly ICH E3 and ICH E6.
• Experience mentoring junior writers a plus.
• Deep understanding of the drug development process.
• Strong ability to assimilate and analytically interpret scientific data; experience preparing data tables and basic figures required.
• Proficient knowledge of AMA style guidelines.
• Excellent attention to detail and time-management skills; ability to balance multiple projects simultaneously.
• Technical proficiency in Microsoft Office and Adobe Acrobat; experience with Veeva and StartingPoint templates is a plus.
• Ability to follow style guides, lexicons, and eCTD templates.
• Excellent written and oral communication skills with the ability to clearly present technical information within and across functional areas.
• Energetic, self-motivated, and a hands-on professional with a strong work ethic.
• Ability to work collaboratively in a dynamic environment; team player with the ability to lead toward common goals.
• Productivity and success in a fast-paced, intense work environment; personable and outgoing.

Education

• Bachelor’s Degree required; advanced degree in a relevant scientific/clinical/regulatory field a plus.