Senior Manager, Medical Writing
About this 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.
• 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
• 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
#LI-JB1 #LI-Remote
U.S. Pay Range
$146,100.00 - $197,700.00
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.
Company at a glance
SILENCE DISEASE. AMPLIFY LIFE.™
Alnylam is a leading independent biopharmaceutical company and the pioneer in RNA interference (RNAi) therapeutics – a revolutionary approach to treating diseases which “silences” the genes that cause or contribute to them.
Founded in 2002 by a group of distinguished researchers and biotech leaders, Alnylam’s work over more than two decades has yielded the critical breakthroughs and advancements that have made the field of (RNAi) therapeutics possible. In 2018, our first commercial medicine, and the world’s first RNAi therapeutic was approved. Since then, five more Alnylam-developed medicines have been approved and we’re hard at work developing new therapies to treat both rare and prevalent diseases.
We are a global and diverse company of 2,600+ people. We pride ourselves on fostering a fun, inclusive and dynamic work environment where employees can recognize their fullest potential. That's why we’re consistently ranked as a top employer by The Boston Globe (2015-25), Science Magazine (2018-25), Fast Company (Best Workplaces for Innovators 2020-25) and Great Place to Work.
We are based in Cambridge, Massachusetts (U.S.), with offices throughout North America, Europe, Asia, and South America.
See our social media community guidelines: https://bit.ly/2FcRhJy.
Please note: If you wish to report an adverse event or product complaint, please email [email protected] or you may call us using the following telephone numbers: for North America, 877.ALNYLAM (877.256.9526), for Europe, +31 20 369 7861
Fraudulent Recruitment Activity
Be aware of the potential for scams and fraudulent recruitment activity from individuals claiming to represent Alnylam Pharmaceuticals. Alnylam never conducts its interview process via messaging apps, freelance sites, or social media platforms. Alnylam team members only communicate with potential candidates through an official Alnylam email address ending in "@alnylam.com."
Top Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- Lifestyle Reimbursement Program
- Flexible Spending Account
- Health Savings Account
- 401(k) With Company Match
- Paid Time Off
- Wellness Days
- Holidays
- Company-wide Recharge Breaks
- Family Resources
- Family Leave
- Annual Short-term Incentive Award
- Annual Long-term Incentive Award
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