Senior Manager, Global Medical Writing

As a key leader, you will oversee the strategic planning and preparation of complex documents across various programs. This position supports both early and late-stage development programs and regulatory submissions.

• Lead medical writing efforts for one or more programs, contributing to various clinical documents such as clinical protocols, study reports, investigator brochures, and integrated summaries of efficacy and safety.
• Author and manage the completion of clinical documents and other tasks within established timelines and department SOPs, ensuring the highest quality in scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines.
• Develop document strategies and messages collaboratively with relevant project team experts.
• Maintain communication with team stakeholders to stay informed about program/regulatory strategies, expectations, milestones, and deliverables.
• Supervise at least one direct report and/or manage the work of CRO consultant writers as needed.

Qualifications

What You’ll Bring:

• PhD in a Life Science or equivalent preferred, Master’s or Bachelor’s degree considered based on experience level.
• 5-7 years of industry experience as a Medical Writer including 2 years as a lead writer. Experience managing people (up to 2 years) in an established Medical Writing group is desirable.