Job Description
We are seeking an experienced and dynamic Principal Medical Writing Manager to join our team and lead the development of clinical regulatory documents across our Translational Medicine (TMed) portfolio. This is an opportunity to make a significant impact in a collaborative and fast-paced environment at the forefront of medical research and development.
The Principal Medical Writing Manager will:
- Lead and manage a team of medical writers and clinical technical editors to ensure the timely and high-quality delivery of clinical regulatory documents, including protocols, pivotal clinical study reports, and submission documents, in accordance with company and regulatory requirements.
- Serve as a subject matter expert in Protocol, CSR templates, processes and authoring platforms, and medical writing processes and standards, providing guidance, mentorship, and training to the medical writing team to enhance their skills and expertise.
- Independently lead and author clinical regulatory documents (e.g., protocols, pivotal clinical study reports, clinical sections of submission, etc.) across all therapeutic areas per company and regulatory requirements.
- Demonstrate expertise in document planning and authoring, and interpretation of data, using own judgment and prior work experience.
- Be recognized as a strong scientific contributor and work collaboratively on cross-functional teams while demonstrating an understanding of team and project leadership responsibilities.
- Apply in-depth knowledge of clinical development, relevant regulations, disease areas, and company products.
- Apply 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.
- Oversee the TMed portfolio of medical writing deliverables, stepping in where needed to cover resource gaps.
Minimum Qualifications, Skills & Experience:
- Degree in a scientific discipline (e.g., life sciences, pharmacy, medicine).
- Bachelor’s degree with 9+ years, master’s degree with 8+ years, or doctorate degree with 7+ years of relevant clinical medical writing experience in the pharmaceutical and/or biotech industry supporting global filings.
- Experience managing complex writing projects and leading project teams of medical writers and cross-functional members.
- Experience in managing people and a portfolio of work.
- Ability to independently prepare a diverse set of clinical regulatory documents (e.g., study protocols, clinical study reports, clinical sections of submissions, etc.) 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.
- Excellent oral and written communication and presentation skills.
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