Principal Medical Writer
About The Position
The Clinical and Regulatory Strategic Communications (CRSC) department within Global Clinical Trial Operations (GCTO) creates regulated content for the development pipeline and enables data sharing. It partners with teams to ensure quality and compliance with applicable laws and applies health literacy principles to public-facing materials. The Principal Medical Writer partners with a project lead to apply strategic and scientific expertise to develop, author, edit, and lead reviews of accurate, clear, compliant clinical, regulatory, and/or public-facing documents across programs and therapeutic areas. The role provides medical-writing subject matter expertise, scientific and cross-functional leadership, oversight of program work, and mentorship to other writers. It may include managing direct reports, including workload, professional development, and performance management.
Requirements
- Bachelor’s degree or higher, preferably in a health, scientific, or relevant discipline such as life sciences, pharmacy, medicine, or public health.
- At least 5 years of relevant medical writing or industry experience.
- Experience managing complex writing projects in a deadline-driven environment and leading teams of medical writers and/or cross-functional team members.
- Ability to critically evaluate and interpret clinical data clearly, objectively, and in accordance with regulatory requirements and industry guidelines.
- Demonstrated critical thinking and problem-solving capabilities, with the ability to innovate, influence, and drive change.
- Demonstrated leadership across organizational levels, including conflict resolution, negotiation, navigating teams through ambiguity, and decision making.
- Excellent oral and written communication and presentation skills.
- Technical expertise in commonly used office applications, such as Microsoft Office Suite, and shared document systems, such as SharePoint, and willingness to learn and adapt to emerging technology.
Nice To Haves
- Experience independently preparing a variety of clinical regulatory documents, such as protocols, clinical study reports, and clinical submission documents, in accordance with regulatory requirements and industry guidelines.
Responsibilities
- Design, plan, author, edit, and lead review of accurate, clear, high-quality documents that follow medical writing best practices and evolving regulatory requirements.
- Contribute scientific expertise and collaborate on cross-functional teams, demonstrating an understanding of team and project leadership responsibilities.
- Apply critical thinking, problem-solving, and negotiation to address complex challenges in documents, content, processes, timelines, and tools.
- Provide program oversight, keep project leads and/or management informed, and escalate issues that could affect timelines, quality, or compliance.
- Use medical writing-specific tools and technology platforms.
- Lead initiatives to improve medical writing processes and standards, and serve as an internal or external resource as appropriate.
- Apply knowledge of clinical development, regulations, disease areas, and company products.
- Provide scientific and operational mentorship, coaching, and/or project oversight to other medical writers.
- May manage direct reports, including workload, professional development, and performance management.
Benefits
- Medical, dental, and vision healthcare benefits
- Other insurance benefits for employees and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Annual bonus and long-term incentive, if applicable
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What This Job Offers
Job Type
Full-time
Career Level
Principal
