Principal Medical Writer

Alnylam Pharmaceuticals; Cambridge (MA); On-site; USD 172,000 - 233,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with company match

Paid time off and holidays

Wellness days

Job summary

Alnylam Pharmaceuticals in Cambridge, MA, is seeking a Principal Medical Writer (equivalent to Associate Director) to lead medical writing on multi-disciplinary teams and oversee contract writers on the clinical program.

You will develop key clinical documents in accordance with GCP, FDA regulations, and SOPs, coordinate filings, mentor junior staff, and collaborate across functions to ensure timely, high-quality submissions.

Qualifications

• Bachelor's degree in Life Science with writing expertise or English/Communications with science background; advanced degree/certifications preferred.
• 7+ years as a medical writer in sponsor/CRO setting; NDA/BLA/MAA submissions experience strongly preferred; CTA/IND experience a plus.
• Experience developing MW processes and standards is a plus.
• In-depth knowledge of GCP, FDA regulations, ICH guidelines, and drug development processes.
• Proven ability to manage multiple projects in fast-paced, deadline-driven environments.
• Experience overseeing contract writers and familiarity with eCTD formatting and EDMS systems.

Responsibilities

• Produce high-quality clinical documents on time.
• Plan, coordinate, develop, update, and revise key documents (protocols, IBs, SCSR, summaries, informed consent forms, etc.).
• Lead supplemental filings, Type 2 Variations, rest-of-world submissions, and clinical responses.
• Provide medical writing leadership to project teams and coordinate with MW management for resourcing.
• Facilitate efficient review and finalization by internal staff and external writers.
• Collaborate with Biometrics, Clinical Operations, Development, QA, and external stakeholders.
• Contribute to templates and processes; train staff and contractors on MW processes.
• Assist line managers in training and development of junior staff.

Skills

Project management

Attention to detail

Cross-functional collaboration

Regulatory submissions awareness

Education

Bachelor's degree in Life Science or English/Communications

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

eCTD formatting

Job description

Principal Medical Writer (equivalent to Associate Director) represents medical writing on multi-disciplinary teams, collaborates on the development of clinical documents in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs), and oversees the work of contract writers on the clinical program as well as other writers who may work on the program.

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 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

AboutAlnylam

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.