Sr. Manager, Medical Writing
Accountabilities: The Sr. Manager, Medical Writing will provide strategic leadership for medical writing activities while managing teams responsible for producing scientific, educational, research, and regulatory documents. This role requires expertise in clinical development, regulatory standards, and the ability to coordinate complex projects across internal and external stakeholders.
Lead and manage the Medical Writing team, providing mentorship, guidance, and support to medical writers.
Oversee the preparation of Phase I–IV clinical and post-marketing regulatory documents, including protocols, clinical study reports, submission documents, safety narratives, and publication materials.
Manage the development of IND, NDA, MAA, and other regulatory submission documentation.
Lead the creation of registry and observational study protocols, reports, REMS assessment reports, KABS reports, abstracts, and manuscripts.
Ensure regulatory documents undergo appropriate peer review, quality control, and publishing processes according to established procedures.
Partner with project teams to develop project plans, timelines, resource strategies, and deliverables.
Collaborate with cross-functional teams including data management, programming, biostatistics, quality assurance, project management, and other scientific groups.
Support continuous improvement initiatives by developing and reviewing standard operating procedures and improving medical writing processes.
Provide expertise in interpreting clinical data and translating complex scientific information into clear, accurate documentation.
Support business development activities by contributing to requests for information (RFIs) and requests for proposals (RFPs).
Maintain high standards for document quality, accuracy, compliance, and timely delivery.
Requirements:
The ideal candidate will have extensive experience in medical regulatory writing, strong leadership capabilities, and a deep understanding of clinical research and pharmaceutical development processes. They should be comfortable managing teams, collaborating across disciplines, and delivering high-quality documentation within complex environments.
Master’s or doctorate degree in biological sciences or a related scientific discipline.
10–15 years of professional experience, including at least 8 years in medical regulatory writing within the pharmaceutical, biotechnology, or CRO industry.
Proven experience leading and managing medical writing teams.
Broad experience across multiple therapeutic areas and phases of clinical studies.
Strong knowledge of clinical trial processes, medical terminology, and regulatory documentation requirements.
Experience preparing and reviewing regulatory submission documents and clinical development materials.
Familiarity with REMS and KAB regulatory programs is preferred.
Strong ability to interpret clinical data and communicate scientific concepts effectively to cross-functional teams.
Advanced proficiency with Microsoft Word, Adobe Pro, and document management systems.
Excellent leadership, organizational, communication, and interpersonal skills.
Strong attention to detail with a commitment to accuracy and quality.
Ability to manage multiple priorities, timelines, and stakeholders effectively.
Benefits:
Opportunity to lead a skilled medical writing team supporting impactful clinical and regulatory programs.
Exposure to diverse therapeutic areas and global clinical development projects.
Collaborative environment working with scientific, regulatory, and operational experts.
Opportunity to influence medical writing processes and operational improvements.
Professional growth through leadership responsibilities and cross-functional collaboration.
Competitive compensation and benefits package.
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