Principal Medical Writer – FSP

This is a fully remote position, open to applicants in United Kingdom, +1 more country.

📋 Description

• Create and refine high-quality clinical, safety, regulatory, device, diagnostics, and disclosure documents throughout various phases of clinical research and across different therapeutic areas.

• Oversee clinical program documentation, including protocols, protocol amendments, Investigator Brochures (IBs), Informed Consent Forms (ICFs), patient narratives, study reports, Periodic Benefit Risk Evaluation Reports (PBRERs), Investigational New Drug applications (INDs), New Drug Applications (NDAs), Biologics License Applications (BLAs), Marketing Authorization Applications (MAAs), and eCTD submission-level documents.

• Liaise with medical writing leadership, department heads, internal teams, and consultants regarding project and program updates.

• Facilitate cross-functional resource coordination and manage medical writing and quality control (QC) deliverables.

• Oversee, train, and guide junior medical writers.

• Handle client expectations, engage directly with clients, lead project meetings, and oversee timelines for deliverables.

• Work collaboratively with clinical operations, data management, biostatistics, regulatory affairs, and other domain experts.

• Organize document QC reviews and maintain comprehensive audit trails.

• Review statistical analysis plans along with table, figure, and listing formats.

• Conduct QC and peer reviews as necessary.

• Develop and uphold timelines, update deliverable trackers, and facilitate internal or client meetings.

• Stay updated on industry standards, regulatory requirements, and medical writing best practices.

• Administer budgets, manage workloads, juggle multiple projects, and address out-of-scope tasks.

• Engage in and lead departmental initiatives like process enhancements and lunch-and-learn sessions.

⛳️ Requirements

• A Bachelor's degree or higher, ideally in a medical or scientific field.

• At least 5 years of experience in writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics.

• Background in a contract research organization, pharmaceutical company, or biotechnology firm.

• In-depth knowledge of clinical research principles.

• Capability to interpret and convey clinical data and complex information effectively.

• Strong understanding of FDA and other relevant regulatory bodies, regulations, and guidelines.

• Advanced comprehension of regulatory submission requirements and procedures.

• Proficiency in computer technology and expert-level skills in MS Word, including the use of tables, graphs, and figures.

• Outstanding project management and communication capabilities.

• Keen attention to detail and commitment to quality.

• Proficiency in the English language.

• Familiarity with the American Medical Association (AMA) style.

• Experience in building relationships and strategically collaborating on important business accounts.

• Ability to identify issues or inefficiencies and propose actionable solutions.

• Excellent time management skills with the ability to work both independently and as part of a team.

🏝️ Benefits

• Support for remote work arrangements.

• Hybrid work model encouraged for new employees living within a reasonable commuting distance of an office, as discussed with the manager.

• An Equal Opportunity Employer committed to fostering a workplace that values diversity, equity, and inclusion.