Senior Manager, Medical Writing

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the Medical Writing team while consulting on and crafting scientific, educational, research, and regulatory documents for client projects.

• Simplify complex concepts and medical terminology tailored to specific target audiences.

• Direct teams and manage projects to ensure timely delivery of high-quality documents that meet quality standards and stay within the departmental budget.

• Provide leadership and management for the Medical Writing division.

• Spearhead the development and preparation of regulatory documents for Phases 1 through IV and post-marketing, including clinical protocols, study reports, study synopses, IND, NDA, and MAA submission documents, safety narratives, registry and observational study protocols and reports, REMS assessment reports, KABS reports, and publication abstracts/manuscripts.

• Ensure peer review and quality assurance of regulatory documents in accordance with SOPs.

• Engage in UBC and client project teams for project planning and timeline establishment.

• Coordinate and consult with SERRM, Data Management, Programming, Biostatistics, Quality Assurance, and Project Management teams.

• Lead the preparation and review of departmental SOPs.

• Participate in RFIs and RFPs to explore business development opportunities.

• Supervise a team of 4–10 medical writers.

⛳️ Requirements

• Master's or doctorate degree in biological sciences or a related field.

• 10–15 years of experience, including a minimum of 8 years in medical regulatory writing or a comparable role within the pharmaceutical/CRO sector.

• Extensive experience across various therapeutic areas and phases of clinical studies.

• Proven leadership experience managing a medical writing team.

• Proficient in Microsoft Word.

• Skilled in Adobe Pro.

• Familiar with various document management systems.

• Knowledgeable in medical terminology and the clinical trial process.

• Preferred familiarity with REMS and KAB regulatory programs.

• Ability to analyze clinical data effectively.

• Strong analytical capabilities.

• Capability to communicate effectively with cross-functional teams.

• Demonstrated leadership and organizational abilities.

• Exceptional attention to detail and a high degree of accuracy.

• Excellent communication and interpersonal skills.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and continuous education.

• Flexible working hours and remote work options.

• Collaborative and innovative work environment.