Principal Medical Writer

Alnylam Pharmaceuticals, Inc.; United States; On-site; USD 172,000 - 233,000; Full time

Job summary

Alnylam Pharmaceuticals, Inc. is seeking an experienced medical writer to lead the preparation and submission of clinical documents across programs, ensuring timely, high-quality deliverables and alignment with regulatory expectations.

You will coordinate with cross-functional groups, manage multiple projects, mentor junior staff, and help standardize MW processes as the team grows. This role offers a competitive US pay range, comprehensive benefits, and opportunities to contribute to RNAi cures.

Qualifications

• Bachelor's degree with writing expertise or English/Communications with science expertise.
• 7+ years as medical writer in sponsor/CRO; NDA/BLA/MAA submissions preferred; CTA/IND a plus.
• Some experience developing MW processes and standards.
• Deep knowledge of GCP, FDA regulations, ICH guidelines, and drug development.
• Proven track record managing multiple projects in fast-paced, deadline-driven environment.
• Knowledge of eCTD formatting and EDMS systems preferred.
• Experience overseeing contract writers.
• Impeccable attention to detail.
• Proficiency with MS Word, Excel, PowerPoint.
• Align with Alnylam Core Values.

Responsibilities

• Produce high-quality and on-time clinical documents
• Plan, coordinate, develop, update, and revise key documents (protocols, investigator brochures, clinical study reports, integrated summaries, etc.)
• Lead supplemental filings, Type 2 Variations, rest-of-world filings, and clinical responses
• Provide medical writing leadership to project teams and coordinate with MW management
• Facilitate review and finalization with internal/external writers
• Collaborate with Biometrics, Clinical Operations, Clinical Development, Pre-Clinical Development, PM, Research, Quality, and Communications, plus external stakeholders
• Develop and standardize MW templates and processes; train staff and contractors
• Assist line managers in training junior staff

Skills

Medical writing

Regulatory submissions

GCP knowledge

Project management

EDMS systems

eCTD formatting

MS Office

Contract writers oversight

Education

Bachelor's degree in Life Science

Advanced degree preferred

Tools

EDMS software

Job description

Responsibilities:

• Produce high-quality and on-time clinical documents
• Independently plan, coordinate, develop, update, and revise key documents, including clinical protocols, investigator brochures, clinical study reports, integrated efficacy and safety summaries, and related documents. Other documents may include informed consent forms, health authority briefing books, and scientific publications.
• Independently lead supplemental filings, Type 2 Variations, rest-of-world filings, and clinical responses to questions
• Provide medical writing subject matter expertise and leadership to project teams and collaborate with the Medical Writing line management to ensure proper planning and resourcing for upcoming project team writing deliverables.
• Facilitate/manage efficient review and finalization process for documents produced internally and/or externally by consultants, contractors and vendors.
• Collaborate effectively with Biometrics, Clinical Operations, Clinical Development, Pre-Clinical Development, Program Management, Research, Quality, and Corporate Communications, as well as with external stakeholders.
• Contribute to the development and standardization of templates and related processes to support the medical writing needs of a growing organization and assist in training staff and contractors on MW processes.
• Assist the line managers in the training and development of junior staff.

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.
• 7+ years of experience as a medical writer in the sponsor/CRO setting. Experience with regulatory submissions (NDA/BLA/MAA) strongly preferred. CTA/IND experience is a plus.
• Some experience with developing MW processes and standards preferred
• 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.
• Knowledge of eCTD formatting and EDMS systems preferred.
• Experience overseeing the work of contract writers.
• Impeccable attention to detail.
• Must be proficient with Microsoft Windows, Word, Excel, and PowerPoint.
• Demonstrate clear alignment with Alnylam Core Values including,

Commitment to Alnylam Core Values

• Commitment to People
• Innovation and Discovery
• Purposeful Urgency
• Open Culture
• Passion for Excellence

U.S. Pay Range

$172,000.00 - $232,800.00

The pay range 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

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.

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.