Senior Manager, Medical Writing - #147714

1808: Senior Manager, Medical Writing

Location: Maidenhead, UK – Hybrid

Travel: Ability to travel approximately 10% is required

At Alnylam, we’re not just developing therapies - we’re redefining what’s possible in medicine. As pioneers of RNA interference (RNAi) therapeutics, we’ve opened the door to a revolutionary class of medicines that silence the genes behind serious diseases. Now, we’re looking for a talented Medical Writer who shares our passion for innovation and excellence to play a pivotal role in shaping the documents that support our clinical development programs. This is a unique opportunity to contribute to life-changing science in a fast-paced, collaborative environment where innovation, excellence, and purpose converge.

If you’re driven by discovery, inspired by purpose, and ready to shape the future of medicine, this is your moment — and Alnylam is your place!

Reporting to the Director, Medical Writing for the UK, this hybrid role is based two days per week at our UK head office in Maidenhead, offering the flexibility of remote work alongside in-person collaboration.

Our global team consists of 19 dedicated professionals located across the UK, Cambridge (US), and Philadelphia (US). Together, we are united by a shared vision: Revolutionizing Medical Writing as we meet patients’ needs for new medicines . We deliver on this by embracing innovation, fostering cross-functional collaboration, and maintaining the highest standards of scientific and technical excellence. With a deep commitment to strategic leadership and transparency, we take pride in producing the documents that support and accelerate the journey of life-changing therapies to the people who need them most.

What You’ll Do…

In this role, you’ll take ownership of key clinical documents, ensuring they meet the highest scientific, regulatory, and quality standards. You’ll collaborate cross-functionally with experts from Clinical Development, Biometrics, Regulatory Affairs, and more - guiding the end-to-end process of document development, from planning through to finalization. You’ll also lead and mentor contract writers, help shape our internal processes, and act as a subject matter expert within the Medical Writing team.

Key Responsibilities

• Independently write and manage core clinical documents (protocols, IBs, CSRs, ISS/ISE, etc.)
• Deliver high-quality writing outputs on time and in compliance with all regulations and SOPs
• Lead document review and approval processes with both internal and external contributors
• Represent Medical Writing across multiple cross-functional project teams
• Collaborate with internal departments and external stakeholders to ensure scientific accuracy and clarity
• Provide guidance and oversight to contract writers
• Contribute to the development and maintenance of SOPs and document templates
  
  

About You…

You’re a subject matter expert; someone who can help translate complex science into compelling, clear, and compliant communications that support our regulatory and clinical goals. You're a proactive, detail-oriented communicator who thrives in a dynamic and mission-driven environment.

You will have…

Essential Qualifications, Skills & Experience

• 6+ years of experience as a medical writer in the sponsor and CRO setting
• Experience planning and writing clinical protocols, investigator brochures, clinical study reports, integrated safety and efficacy summaries and related documents
• Experience of regulatory submissions (CTA/IND/NDA/BLA) - knowledge of eCTD formatting would be advantageous
• A bachelor's degree (or equivalent) in Life Science or comparable subject area, with relevant writing expertise or in English/Communications with relevant science expertise
• In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process
• Impeccable attention to detail and ability to complete writing assignments in a timely manner
• A strong track record of successfully managing multiple projects in a fast-paced and deadline-driven environment
  
  

Desirable Skills And Experience

• Advanced degree and/or professional certification/credentials
• Experience overseeing the work of contract writers would be beneficial
• Demonstrate clear alignment with Alnylam’s core values
  
  

Are you ready to be part of what’s next? Join us and help bring groundbreaking RNAi therapies to patients around the world.

Next Steps

This vacancy will be advertised from Friday, 9 th May with a scheduled closing date of Friday, 23 rd May – we welcome your application as soon as possible.

Additional Resources

The Medical Writing team sits within our Regulatory Affairs group – find out more, here:

Alnylam Regulatory Affairs: https://www.alnylam.com/regulatory-affairs

Working at Alnylam: https://www.alnylam.com/careers/working-at-alnylam

Who We Are: https://www.alnylam.com/careers/who-we-are