Sr. / Principal Medical Writer (Regulatory focus) – Sponsor-dedicated; NA/CAN/UK

About This Opportunity

We are representing a confidential life sciences organization seeking an experienced Senior or Principal Medical Writer with a regulatory focus to join a sponsor-dedicated team. This is a remote position open to candidates in the United States, Canada, or the United Kingdom.

Our client partners with innovators across the drug development continuum, and this role will be embedded within a specific sponsor environment where you'll lead the creation of regulatory documentation that advances patient outcomes.

Responsibilities

• Lead the development and completion of regulatory medical writing deliverables, ensuring scientific accuracy and clarity across all documents
• Manage medical writing activities for individual clinical studies, coordinating across departments with minimal supervision
• Author a variety of regulatory documents including clinical study protocols and amendments, clinical study reports, patient narratives, investigator brochures, informed consents, IND submissions, NDA and eCTD submissions, periodic safety update reports, integrated summary reports (ISE/ISS), and briefing books
• Lead resolution of client comments and coordinate quality and editorial reviews
• Ensure compliance with ICH E3 guidelines, SOPs, and client standards while meeting timelines and budgets
• Act as peer reviewer for internal team members, ensuring scientific content, consistency, and proper formatting
• Review statistical analysis plans and table/figure/listing specifications, providing feedback on statistical output requirements
• Collaborate with cross-functional teams including biostatistics, data management, regulatory affairs, and medical affairs
• Mentor and provide technical guidance to less experienced medical writers on complex projects
• Conduct clinical literature searches and ensure copyright compliance
• Manage project budgets and communicate status to leadership
• Travel requirements are minimal (less than 25%)

What We're Looking For

• Minimum 5 years of lead regulatory medical writing experience in pharmaceutical or clinical research environments
• Demonstrated lead writer experience across Phase 2 and Phase 3 clinical trials
• Proven expertise authoring protocols, regulatory submissions, CTD Module 2.7.3 and 2.7.4 (Clinical Summary of Safety), clinical study reports, investigator brochures, patient narratives, safety aggregate reports, briefing books, and integrated summaries (ISE/ISS)
• Strong project management capabilities with the ability to manage multiple deliverables simultaneously
• Excellent client management experience and communication skills
• Superior time management abilities and attention to detail
• Deep knowledge of regulatory requirements and guidelines affecting medical writing
• Experience with process improvement initiatives is highly valued
• Advanced degree in life sciences, pharmacy, or related field preferred
• Must be authorized to work in the US, Canada, or UK

How We Work With You

When you apply through Get A Job.ai, our talent team will review your background and conduct an initial screening to understand your experience and career goals. If there's a strong match, we will submit your profile to our client for consideration. Please do not contact the client directly—all communication and coordination will flow through our recruiting team to ensure a smooth, professional process.

Pay

Compensation details will be discussed during the screening process and will be competitive based on your experience level and qualifications.

Equal Employment Opportunity: Get A Job.ai is committed to creating an inclusive environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.