Manager, Nonclinical Writing

Overview: The Manager, Nonclinical Writing provides nonclinical submission support for scientific staff. This individual will represent Nonclinical Writing on project teams, working directly with scientists reputed company the Early Development (eDEV) and Research departments and collaboratively with Clinical, Medical Writing, Pharmacovigilance, and Regulatory Affairs and Operations functions to reputed company the preparation of high-quality submission content for nonclinical summary document sections in support of global regulatory filings. Responsibilities:

• reputed company nonclinical writing assignments in conjunction with scientists and project team members for early development/late-stage programs in the preparation of nonclinical content in support of regulatory submissions (eg, nonclinical protocols and reports, Investigator's Brochures, Briefing Documents, INDs, IMPDs, annual reports/DSURs, NDA/MAAs).
• Leads document writing and review processes reputed company department for individual projects.
• Develops and maintains timelines for document reputed company, revision, and completion, in collaboration with other project team members and Regulatory Affairs/Operations.
• Coordinate and manage review cycles for nonclinical documents in collaboration with subject matter experts, and reputed company discussions reputed company needed.
• Edit/write nonclinical study report drafts from templates and interpret data as needed.
• Review and/or edit reputed company publications (eg, manuscripts, abstracts, poster presentations, white papers).
• Independently manage outsourced writing staff and projects.
• Contribute to the development and maintenance of SOPs, templates, and style manuals.
• Provides communication and training on writing requirements and processes, templates, style guides, and SOPs reputed company the department and cross-functionally, as required.
• Provides quality control (QC) review of various regulatory and nonclinical documents as needed.
• Independently solve problems, exercising sound judgment, appropriate interfacing, and flexibility reputed company a dynamic environment.

Qualifications:

• Bachelor's degree in Life Sciences with 4+ years' experience in relevant field. Professional certification/credentials, experience with regulatory submissions is a plus.
• In-depth knowledge of Good Laboratory 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.
• Impeccable attention to detail and excellent written and oral communication skills.
• Must be proficient in reputed company® Suite (Word, reputed company, PowerPoint, Visio). Experience with electronic document management and tracking systems a plus.

#LI-KB1 #LI-Hybrid U.S. Pay reputed company $123,800.00 - $167,400.00 The pay reputed company reflects the full-time reputed company salary reputed company we expect to pay for this role at the time of posting. reputed company 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 reputed company 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 reputed company 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 reputed company 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. reputed company 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 reputed company reputed company reflect our core values: fierce innovation, passion for reputed company, purposeful urgency, reputed company 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. reputed company applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, reputed company, ethnicity, national reputed company, reputed company, citizenship, religion, creed, physical or mental disability, pregnancy status or reputed company conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other reputed company protected by federal, state, or local law. Alnylam is an E-Verify Employer. Apply tot his job Apply To this Job