Sr Manager, Medical Writing

This role is considered Hybrid.

Overview

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 finalization 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.

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.