New · posted Oct 31
Alnylam Pharmaceuticals · Biotechnology
Sr Manager, Medical Writing
- United States
- On-site
- Full-time
- Manager
The role
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.
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).
What you need
- 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
What you'll do
- 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
Pay and benefits
$146,100 – $197,700 a year
Employer providedMedical, dental, and vision coverage
Life and disability insurance
401(k) with company match
Paid time off and wellness days
Annual bonus and equity eligibility
Family resources and leave
Where you'll work
United StatesOn-siteOpen in Maps (opens in a new tab)
From the posting
About Alnylam
We are the leader in RNAi therapeutics – a revolutionary approach 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 possible and 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, where an authentic, inclusive culture and breakthrough thinking fuel one another.
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
Equal opportunity, accessibility and legal noticesAlnylam Pharmaceuticals's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 31, 2026
Salary intelligence
How the pay compares
This roleEmployer provided
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $146,100 | — | $197,700 |
This role: Alnylam Pharmaceuticals's own published range.
Career trajectory
Where this role sits in Clinical Evaluation & Medical Writing
The general path across 21 open Clinical Evaluation & Medical Writing roles on Regulatory Jobs, with the titles they carry most. Not Alnylam's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 15 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs9
- Collaboration and leadership4
- Clinical trial conduct3
- GMP and compliance2
- Investigations and CAPA1
- Regulatory submissions1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
- FDAeCTD(official source, opens in a new tab)The electronic Common Technical Document format for submissions
Company hiring pulse
Alnylam on Regulatory Jobs
- 15
- Open roles
- 14
- Distinct roles
- 4
- Locations
By discipline
- Clinical8 53%
- Regulatory4 27%
- Quality3 20%
By level
- Director8 53%
- Manager3 20%
- Senior & Principal2 13%
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Sr Manager, Medical Writing at Alnylam
Open until filled. $146K–$198K a year, employer provided.