The Senior Manager, Medical Writing will partner closely with cross-functional project teams to plan, develop, and deliver high-quality clinical and regulatory documents in compliance with global regulations, Good Clinical Practice (GCP), and internal SOPs.
This role plays a key part within the Central Nervous System (CNS) therapeutic area, contributing both hands‑on expertise and strategic oversight while collaborating with internal stakeholders and external partners.
This hybrid position requires two days per week in our Maidenhead office.
Key Responsibilities
* Produce high-quality, on-time medical writing deliverables across the clinical development lifecycle.
* Independently plan, write, edit, and format key documents including clinical protocols, investigator brochures, clinical study reports, and integrated summaries of safety and efficacy.
* Represent Medical Writing on CNS project teams, collaborating across functions to support program goals and timelines.
* Facilitate efficient document review and finalisation processes for materials developed internally and/or by external vendors and contract writers.
* Oversee and provide direction to contract medical writers, ensuring consistency, quality, and adherence to standards.
* Engage confidently with a broad range of stakeholders, demonstrating strong stakeholder management, clear communication, and the ability to manage expectations with a sense of urgency.
* Prepare effectively for cross‑functional meetings and maintain a strong "big‑picture" mindset while delivering at pace.
* Contribute to the development and maintenance of medical writing SOPs and templates.
Required Qualifications
* Bachelor’s degree in Life Sciences with relevant writing expertise, or in English/Communications with strong scientific experience; advanced degree or professional certification preferred.
* 6+ years of experience as a medical writer within a pharmaceutical organisation preferably.
* In‑depth knowledge of GCP, FDA regulations, ICH guidelines, and the drug development process.
* Demonstrated ability to manage multiple priorities in a fast‑paced, deadline‑driven environment.
* Proven ability to work collaboratively, communicate openly, and adapt writing style for different audiences.
* Flexibility to work across global time zones, with the majority of stakeholders based in U.S. Eastern Time (EST).
* High attention to detail and strong proficiency with Microsoft Word, Excel, and PowerPoint.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity.
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