Sr Manager, Medical Writing

Regulatory Toolkit; United States; On-site; USD 146,000 - 198,000; Full time

Job summary

Alnylam is seeking a Senior Manager, Medical Writing to lead the development of clinical documents in compliance with GCP, FDA regulations, and SOPs. You will oversee contract writers and partner with project teams to ensure timely, high-quality deliverables.

The role requires extensive experience in medical writing, regulatory submissions, and cross-functional collaboration across clinical development and regulatory affairs.

Qualifications

• Bachelor's degree in Life Science with writing expertise or English/Communications with science knowledge
• 6+ years as a medical writer in sponsor/CRO setting, regulatory submissions experience a plus
• Solid knowledge of GCP, FDA regulations, ICH guidelines, and drug development processes
• Proven ability to manage multiple projects in fast-paced environments
• Experience supervising contract writers; proficient with MS Office tools

Responsibilities

• Produce high quality, on-time medical writing deliverables
• Plan, write, edit, and format protocols, IBs, CSRs, and integrated summaries
• Manage review and finalization processes with internal and external stakeholders
• Represent Medical Writing on project teams and coordinate resourcing
• Collaborate with cross-functional teams and external vendors
• Serve as SME for clinical documents and SOP/template maintenance

Skills

Medical writing

Regulatory submissions

Project management

Editing

Communication

Education

Bachelor's in Life Science or English/Communications

Tools

Microsoft Word

Excel

PowerPoint

Windows

Job description

OVERVIEW:

The Senior Manager, Medical Writing will collaborate with project teams on the development of clinical documents in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs) and will oversee the work of contract writers on the clinical program.

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 effectively 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
• 6+ years of 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 with 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, and Passion for Excellence

About Alnylam

We are the leader in RNAi therapeutics– a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

Before applying, please review Alnylam's Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.

The pay range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

U.S. Pay Range

$146,100—$197,700 USD