Principal Medical Writer - Oncology

Job Description

The Principal Medical Writer is responsible for leading medical writing deliverables that support the clinical regulatory writing portfolio. The Principal Medical Writer: 

• Independently leads and authors clinical regulatory documents (e.g., protocols, pivotal clinical study reports, clinical sections of submission) per company and regulatory requirements. 

• Demonstrates expertise as a subject matter expert in document planning and authoring, and interpretation of data, using own judgment and prior work experience. 

• Is recognized as a strong scientific contributor and works collaboratively on cross-functional teams while demonstrating an understanding of team and project leadership responsibilities. 

• Applies in-depth knowledge of clinical development, relevant regulations, disease areas, and company products. 

• Demonstrates a developing understanding of the pharmaceutical industry beyond clinical research.

• Applies critical thinking, problem solving and negotiation skills to implement innovative solutions to complex challenges across the medical writing scope of work (e.g., documents, processes, tools) while navigating project team dynamics.

• Demonstrates expertise in medical writing-specific tools and technology platforms. 

• Provides leadership in initiatives to improve medical writing processes and standards. 

• May provide scientific and operational mentorship, coaching and/or project oversight to support other medical writers.

Minimum required education:

• Degree in a scientific discipline (e.g., life sciences, pharmacy, medicine). 

• Bachelor’s degree with 7+ years, master’s degree with 6+ years, or doctorate degree with 5+ years of relevant medical writing experience in the pharmaceutical and/or biotech industry.

Required experience and skills:

• Ability to independently prepare a diverse set of clinical regulatory documents (e.g., study protocols, clinical study reports, clinical sections of submissions) per regulatory requirements and industry guidelines.  

• Ability to critically analyze and present clinical data clearly and objectively, without supervision.

• Demonstrated critical thinking and problem-solving capabilities with an ability to innovate and drive change.

• Experience managing complex writing projects and leading project teams of medical writers and cross-functional members.

• Excellent oral and written communication and presentation skills.

• Technical expertise in office applications (e.g., Microsoft Office Suite), shared document systems (e.g., SharePoint) and concepts of structured content management.

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