Principal Medical Writer - Regulatory and Medical Writing

Ionis Pharmaceuticals • Carlsbad, CA

444d • $126,339 - $160,340 • Remote

About The Position

The Principal Medical Writer will lead and manage the writing of clinical regulatory documents, collaborating with internal teams to ensure compliance with US and international regulations. This role requires advanced regulatory writing expertise and involves responsibilities throughout the document lifecycle, including data interpretation, quality control, and regulatory submissions. The position may be fully remote, with a preference for candidates based in San Diego, CA.

Requirements

• Bachelor's Degree required; advanced degree in a relevant scientific/clinical/regulatory field is a plus.
• Minimum of 8 years of direct experience as a medical writer in the pharmaceutical industry.
• Experience as lead writer of key documents for major US and/or international regulatory submissions.
• Marketing application experience required, particularly with Module 2.5, 2.7.3, or 2.7.4.
• In-depth experience writing Safety sections of regulatory documents preferred.
• Strong ability to assimilate and analytically interpret scientific data.
• Proficient knowledge of American Medical Association (AMA) style guidelines.
• Excellent attention to detail and time-management skills.
• Technical expertise in Microsoft Office and Adobe Acrobat.

Nice To Haves

• Experience mentoring junior writers.
• Rare disease experience is a plus.
• Experience working in Veeva and with StartingPoint templates is a plus.

Responsibilities

• Collaborate with internal teams to lead, write, and manage complex clinical regulatory documents.
• 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 timelines for deliverables.
• Lead complex scientific key messaging/storyboarding cross-functional meetings.
• Ensure compliance with appropriate conventions, grammar usage, and format requirements.
• Manage review cycles for documents and schedule related meetings.
• Perform quality control (QC) reviews as necessary.
• Interact with Quality Assurance (QA) to resolve audit findings.
• Maintain expert knowledge of US and international regulations related to regulatory documentation.
• Coordinate with Regulatory Operations for on-time preparation and publication of regulatory submission documents.
• Support Global Regulatory Lead with preparing information/responses for regulatory agencies.
• Mentor junior writers as needed.

Benefits

• Comprehensive health insurance coverage.
• 401k retirement savings plan.
• Flexible work environment with remote options.
• Professional development opportunities.
• Paid time off and holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree