Senior Manager, Medical Writing

Overview

The Sr. Manager, Medical Writing role will be responsible for managing in‑house and/or contract medical writers, leading and advising on medical writing strategies for individual project teams, and contributing to the management of operational plans and innovative solutions for all medical writing activities across OPDC.

• Proactively manages writing activities across diverse therapeutic programs, applying knowledge and experience while ensuring adherence to the medical writing strategy and alignment with business needs.
• Contributes to therapeutic project teams as the medical writing expert for clinical and regulatory submission documents and, where applicable, authors deliverables with consideration for regulatory, corporate, departmental, and quality standards.
• Manages and provides mentorship of in‑house and/or contract Medical Writing Staff.
• Authors/edits regulatory submission documents, or reviews deliverables produced by the team with consideration for regulatory, corporate, departmental, and quality standards (documents include but are not limited to clinical study reports, Investigator’s Brochures, annual reports, briefing packages, and integrated data summary reports).
• Adheres to the global Medical Writing team’s practices and utilizes the systems and tools available to support document development in order to meet company goals and objectives. Assures that standardized practices are implemented and maintained across all therapeutic areas.
• Engages with team members to ensure medical writing continues to deliver value to the business.
• Ensures medical writing activities meet quality standards and expectations and adhere to applicable corporate SOPs, WPs, policies, guidelines and regulations.
• Provides training and communications to internal stakeholders and providers regarding the medical writing process, best practices and process improvements.
• Reviews new ICH and FDA guidelines regarding medical writing, evaluates their impact on the organization and makes recommendations on the need to develop and/or enhance SOPs and work processes.
• Supports innovation initiatives within the Medical Writing Group and/or represents Medical Writing in other departmental innovation initiatives.
• Authors and/or edits key regulatory documents as needed, including but not limited to clinical study reports, investigator’s brochures, annual reports, briefing packages, and integrated data reports.
• Reviews medical writing deliverables against quality and in‑house standards. Manages the quality control (QC) review of published and non‑published deliverables.
• Represents medical writing on project teams, including attendance at team meetings, communication of project status and critical path issues, and provision of dates to project management team for input into the clinical trial management system (IMPACT).
• Provides project management services for medical writing projects, including timeline management, budget recommendations, issue resolutions, among other tasks.
• Provides relevant and timely project information to the head of medical writing, ensuring that adequate coverage of medical writing needs is maintained in accordance with the company’s goals and objectives.
• Adheres to and helps maintain departmental SOPs and working practices, including the necessary model documents and style guidelines, for standardized processes and style expectations across projects.
• Mentors and trains external writing staff and other departments on medical writing tools and/or business processes.
• Provides backup support for other medical writing staff.

• At least 8 years pharmaceutical/biotechnology experience. 6+ years medical writing experience in Pharma, Biotech and/or CRO.
• Demonstrated expertise in writing/developing clinical documents in support of regulatory submissions globally.
• Ability to interpret and organize scientific and clinical data.
• Previous supervisory or mentorship experience preferred.
• Excellent project management and communication skills.
• Ability to work with cross‑functional teams in a highly matrixed team environment, collaborate with a wide variety of internal customers and relate…