Principal Medical Writer - Regulatory and Medical Writing

Ionis Pharmaceuticals is seeking a Principal Medical Writer - Regulatory and Medical Writing to collaborate with internal teams to lead, write, and manage completion of clinical regulatory documents. The ideal candidate will have 8+ years of direct experience as a medical writer preparing regulated documents in the pharmaceutical industry and marketing application experience. This role may be fully remote; however, preference will be given to San Diego-based applicants.

Requirements

• 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
• Experience as lead writer of key documents included in major US and/or international regulatory submissions
• In depth experience writing Safety sections of regulatory documents preferred
• Extensive working knowledge of relevant FDA, EMA, and ICH guidelines, particularly ICH E3 and ICH E6
• Ability to independently write and complete documents to completion
• Experience mentoring junior writers a plus
• Deep understanding of the drug development process
• Strong ability to assimilate and analytically interpret scientific data
• Proficient knowledge of American Medical Association (AMA) style guidelines
• Advanced abilities to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy
• Excellent attention to detail and time-management skills
• Technical expertise in typical Office applications (Microsoft Office, Adobe Acrobat)
• Ability to follow style guides, lexicons, and eCTD templates etc.
• Excellent written and oral communication skills
• Energetic, self-motivated, and a hands-on professional with a strong work ethic
• Ability to work collaboratively in a dynamic environment
• Strong desire and ability to be a team player, working and leading towards common goals
• An ability to be productive and successful in an intense work environment
• Personable and outgoing

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance