Sr. / Principal Medical Writer (Regulatory focus) - Sponsor-dedicated

📋 Description

• Lead the preparation and delivery of clear, scientifically accurate, and regulatory-compliant
• Develop and oversee a wide range of documents, including clinical study protocols and amendments
• Lead writing activities for CTD Modules 2.7.3 and 2.7.4, integrated summaries of efficacy and
• Coordinate medical writing activities across departments, manage document reviews, resolve client
• Apply relevant regulatory standards and guidelines, including ICH E3, as well as approved
• Coordinate quality and editorial reviews, manage source documentation appropriately, and perform

🎯 Requirements

• Minimum of 5 years of lead regulatory medical writing experience.
• Demonstrated lead-writing experience supporting Phase 2 and Phase 3 clinical development programs.
• Proven experience as lead writer for protocols, regulatory submissions, CTD Modules 2.7.3 and
• Experience with safety aggregate reports is strongly valued, along with experience preparing
• Strong understanding of regulatory medical writing principles, clinical development processes, and
• Excellent scientific writing, editing, proofreading, and document-quality skills, with a strong

🎁 Benefits

• Salary: $80,600–$175,700 annual base salary range, with actual compensation determined by
• Remote work: Remote position with flexibility based on approved locations.
• Healthcare: Medical, dental, and vision benefits.
• Retirement: 401(k) plan with company matching.
• Employee stock: Eligibility to participate in an Employee Stock Purchase Plan.
• Performance incentives: Eligibility to earn commissions or bonuses based on company and individual