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 within the Early Development (eDEV) and Research departments and collaboratively with Clinical, Medical Writing, Pharmacovigilance, and Regulatory Affairs and Operations functions to lead the preparation of high-quality submission content for nonclinical summary document sections in support of global regulatory filings.
Responsibilities:
• Lead 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 within department for individual projects.
• Develops and maintains timelines for document generation, 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 lead discussions when needed.
• Edit/write nonclinical study report drafts from templates and interpret data as needed.
• Review and/or edit internal and external 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 within 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 within 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 Microsoft® Suite (Word, Excel, PowerPoint, Visio). Experience with electronic document management and tracking systems a plus.
#LI-KB1 #LI-Hybrid
U.S. Pay Range
$123,800.00 - $167,400.00
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.
Apply Now
Apply Now
The Manager, Nonclinical Writing provides nonclinical submission support for scientific staff. This individual will represent Nonclinical Writing on project teams, working directly with scientists within the Early Development (eDEV) and Research departments and collaboratively with Clinical, Medical Writing, Pharmacovigilance, and Regulatory Affairs and Operations functions to lead the preparation of high-quality submission content for nonclinical summary document sections in support of global regulatory filings.
Responsibilities:
• Lead 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 within department for individual projects.
• Develops and maintains timelines for document generation, 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 lead discussions when needed.
• Edit/write nonclinical study report drafts from templates and interpret data as needed.
• Review and/or edit internal and external 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 within 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 within 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 Microsoft® Suite (Word, Excel, PowerPoint, Visio). Experience with electronic document management and tracking systems a plus.
#LI-KB1 #LI-Hybrid
U.S. Pay Range
$123,800.00 - $167,400.00
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.
Apply Now
Apply Now