Principal Medical Writer

This is a fully remote position, open to applicants in United Kingdom, +3 more countries.

📋 Description

• Spearhead the creation of high-quality regulatory and clinical documents that convey scientific and medical information.

• Manage medical writing workstreams to ensure that deliverables align with quality standards and timelines.

• Direct the preparation and evaluation of clinical study reports, protocols, and other regulatory documents.

• Collaborate with clinical research, biostatistics, and regulatory affairs teams to collect and integrate information.

• Offer guidance on medical writing best practices and ensure compliance with regulatory requirements and internal standards.

• Mentor and train junior medical writers.

• Remain updated on industry trends and regulatory guidelines.

• Serve as the principal medical writer for complex projects and lead clinical/regulatory marketing approval applications for new biologics and pharmaceuticals.

• Execute all Senior Medical Writer responsibilities while also leading the writing of regulatory approval applications.

⛳️ Requirements

• A bachelor’s degree in life sciences, pharmacy, or a related field.

• Extensive experience in medical writing, especially in regulatory submissions and clinical documentation.

• In-depth knowledge of regulatory requirements and industry standards for clinical writing.

• Outstanding writing and editing abilities, with a sharp focus on detail and clarity.

• A minimum of 5 years of experience writing for the pharmaceutical or biotechnology sector is preferred.

• At least 3 years of experience with electronic documents and submissions is required.

• Experience in drafting key documents for major international regulatory submissions is necessary, including Clinical Study Reports, Investigator Brochures, and Protocols.

• Experience overseeing writing activities for a significant international regulatory submission is preferred.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.