Principal Medical Writer at Alnylam Pharmaceuticals in United States

Job description

• The 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.

Requirements

• 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.

Skills

Required

• Medical writing
• Regulatory writing
• Clinical document development
• Knowledge of Good Clinical Practices
• Knowledge of FDA regulations
• Knowledge of ICH guidelines
• Knowledge of drug development process
• Project management
• Attention to detail
• Microsoft Windows
• Microsoft Word
• Microsoft Excel

Preferred

• CTA/IND experience
• Knowledge of eCTD formatting
• Knowledge of EDMS systems

Benefits

• 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
• 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).
• $172,000 - $232,800 USD