Senior Manager, Medical Writing role at Alnylam Pharmaceuticals
This role is a hybrid position based in Maidenhead, UK. The successful candidate will work at least 2 days per week in the Maidenhead office; virtual or remote applicants will not be considered.
The Senior Manager, Medical Writing will collaborate with project teams on the development of clinical documents in accordance with applicable regulations, Good Clinical Practices, and SOPs, and will oversee the work of contract writers on the clinical program.
Key Responsibilities
* Produce high quality and on-time writing deliverables.
* Independently plan, write, edit, and format key documents, including clinical protocols, investigator brochures, clinical study reports, integrated safety and efficacy summaries and related documents.
* Facilitate/manage efficient review and finalization process for documents produced internally and/or externally by consultants, contractors and vendors.
* Represent Medical Writing on multiple early phase project teams or on specific late phase project teams and collaborate with the Director of Medical Writing to ensure proper planning and resourcing for upcoming project writing deliverables.
* Collaborate with Biometrics, Clinical Operations, Clinical Development, Regulatory Affairs, Pre-Clinical Development, Program Management, Research, Quality, and Corporate Communications, as well as with external stakeholders.
* Serve as subject matter expert for clinical documents and their production.
* Contribute to SOP and template development and maintenance.
Qualifications
* Bachelor's degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise. Advanced degree and/or professional certification/credentials preferred.
* Experience as a medical writer in the sponsor and/or CRO setting. Experience with regulatory submissions (CTA/IND/NDA/BLA) and knowledge of eCTD formatting is a plus.
* In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
* Successful track record of managing multiple projects in a fast-paced and deadline-driven environment.
* Impeccable attention to detail and ability to complete writing assignments in a timely manner.
* Experience overseeing the work of contract writers is a plus.
* Must be proficient with Microsoft Windows, Word, Excel, and PowerPoint.
* Ability to travel approximately 10% is required.
* Demonstrate clear alignment with Alnylam Core Values including:
* Commitment to People
* Fiercely Innovative
* Purposeful Urgency
* Open Culture
* Passion for Excellence
About Alnylam
Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a new class of medicines with the potential to transform lives. Since 2002, Alnylam has driven the RNAi Revolution and continues to turn scientific possibility into reality.
Our culture centers on our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people. We are proud to be recognized as a top employer and committed to an inclusive recruitment process and equal employment opportunity. We strive to create an environment where employees can bring their authentic selves to work and reach their full potential.
Maidenhead, England, United Kingdom
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Marketing, Public Relations, and Writing/Editing
Referrals increase your chances of interviewing at Alnylam Pharmaceuticals.
#J-18808-Ljbffr