Senior Nonclinical Documentation Associate

Alnylam Pharmaceuticals; Cambridge (MA); Hybrid; USD 87,000 - 118,000; Full time

Job summary

Alnylam Pharmaceuticals in Cambridge, MA seeks a Sr. Documentation Associate to support nonclinical documentation, quality control, publishing, and archiving per regulatory standards. Hybrid role with on-site engagement aligned to team needs.

The position requires a technical or scientific degree and 4+ years in biotechnology/pharma document management, with proficiency in Microsoft Office, Adobe Acrobat, and electronic publishing systems. AI-enabled tools familiarity is a plus.

Qualifications

• Bachelor's degree in a relevant technical or scientific field, or equivalent experience
• 4+ years biotechnology/pharmaceutical or CRO experience with document QC, management, and electronic publishing
• Experience with electronic document management systems
• Proficient with Microsoft Windows, MS Office (Word, Excel, PowerPoint), and Adobe Acrobat; exposure to StartingPoint templates, SharePoint and DXC Toolbox
• Familiarity with global regulatory requirements (21 CFR Parts 11, 58, 312, 314; CDER/CBER; OECD; ICH; eCTD SEND)
• Ability to learn AI-enabled software tools and adapt to new platforms
• Strong detail orientation, analytical skills, and ability to manage multiple projects in a fast-paced environment

Responsibilities

• Respond to nonclinical document control requests and help optimize processes and systems
• Monitor version control and ensure good documentation practices
• Manage document workflows and coordinate timely completion
• Provide basic training on processes to nonclinical teams
• Act as SME for document format QC and submission-ready prep of nonclinical documents
• Format MS Word submission components per Alnylam style and regulatory requirements
• Perform basic electronic publishing QC of hyperlinks and bookmarks
• Archive nonclinical records properly
• Publish nonclinical study reports in PDF with cross-functional teams
• Create and maintain Nonclinical Writing templates per regulatory and internal style guides
• Collaborate with cross-functional teams
• Assist with SOPs for PDF prep, QC, document mgmt, and regulatory compliance
• Contribute to development/maintenance of Early Development systems and software

Skills

Attention to detail

Analytical thinking

Multitasking

Communication

Regulatory awareness

Learning agility

Project management

Education

Bachelor's degree in a relevant technical or scientific field

Tools

Microsoft Office Suite

Adobe Acrobat

SharePoint

StartingPoint templates

DXC Toolbox

AI-enabled solutions

Job description

Overview

The Sr. Documentation Associate is an important member of our Nonclinical Writing and Documentation Team providing support to Nonclinical Writing and Scientific Staff in various capacities to ensure that high-quality documentation is produced. The position will include, but is not limited to, document quality review (including formatting and adherence to regulatory requirements), publishing, and archiving of nonclinical documentation according to departmental standards and defined timelines. Addtionally, this role will support organizational technology platforms and departmental initiatives.

Hybrid role based in Cambridge, MA, with onsite presence aligned to team and business needs.

Responsibilities

• Respond to requests for nonclinical document control assistance and seek input for continued optimization of process and systems
• Monitor the document control process to ensure version control is maintained and good documention practices and procedures are being followed
• Manage document workflows and coordinate with appropriate staff to ensure timely completion
• Provide technical training and process orientation to nonclinical stakeholder teams
• Serve as a subject matter expert for document format quality check (QC) review and submission-ready preparation of nonclinical documents (eg, protocols, reports, and associated amendments)
• Ensure MS Word submission components are formatted in accordance with Alnylam style and regulatory requirements. Provide troubleshooting of formatting issues as they arise.
• Perform basic electronic publishing QC of hyperlinks and bookmarks for nonclinical documents to ensure they meet Alnylam submission-ready guidelines
• Ensure nonclinical records are archived appropriately
• Work in partnership across expertise areas within Research and Early Development to assemble and publish nonclinical study reports in PDF format
• Assist with the creation and maintenance of Nonclinical Writing document templates and ensure adherence to global regulatory requirements and internal style guide(s)
• Collaborate effectively with Nonclinical Writing and cross-functional teams
• Assist with writing, reviewing, finalizing, and maintaining internal best practices and standard operating procedures (SOPs) pertaining to PDF preparation, QC, document management, and compliance with applicable regulatory and GxP expectations
• May participate in the development, implementation, and maintenance of Early Development systems and software (eg, electronic document management systems, reference databases, document review software, AI-enabled solutions)

Qualifications

• Bachelor's degree in a relevant technical or scientific field, or an equivalent combination of education and experience
• 4+ years of biotechnology/pharmaceutical or CRO experience with document QC, document management, and electronic publishing in a controlled or regulatory environment
• Experience with electronic document management systems
• Must be proficient with Microsoft Windows, MS Suite (Word, Excel, PowerPoint), and Adobe Acrobat; exposure to StartingPoint templates, Sharepoint and DXC Toolbox is a plus
• Familiarity/general understanding of global regulatory requirements, including but not limited to, 21CFR Parts 11, 58, 312, and 314, CDER/CBER, OECD, ICH guidelines, and eCTD submission requirements and submission processes, including Standard for Exchange of Nonclinical Data (SEND)
• Confidence and ability to learn new software tools, including AI-enabled solutions, is essential
• Must be flexible, detail-oriented, and possess good analytical and problem-solving skills
• Successful track record of managing multiple projects in a fast-paced and deadline-driven environment

About Alnylam

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.

Before applying, please review Alnylam's CandidatePrivacy Noticeregarding how Alnylam handles Personal Data you provide with your application for employment.

U.S. Pay Range

$87,000 — $117,800 USD

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).

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 your 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