Head of Medical Writing
EU-Based, Remote.
As Head of Medical Writing, you will shape the strategy and operational excellence of our global medical writing team. You’ll oversee the development of high-quality clinical and regulatory documents across all phases of development, ensuring compliance, clarity, and scientific accuracy.
Key Responsibilities
- Lead and mentor a global team of medical writers across various therapeutic areas and development stages.
- Oversee the planning, preparation, delivery and submission of regulatory and clinical documents (e.g. CSRs, IBs, CTD modules, briefing documents, MAA’s).
- Support cross-functionally with Clinical Development, Regulatory Affairs, Biometrics, and Pharmacovigilance teams.
- Represent medical writing in strategic discussions with sponsors, regulators, and internal leadership.
Requirements
- Degree (PhD, PharmD, MD, or MSc) in a life sciences discipline.
- 10+ years experience in medical writing, with at least 3 years in a leadership or management role.
- Deep understanding of EMA/FDA regulatory requirements, and industry standards.
- Demonstrated ability to manage multiple projects, timelines, and teams in a matrixed environment.
- Strong interpersonal skills and proven leadership in a global, fast-paced setting.
If you are looking for your next contract project, we’d love to hear from you.