Senior Nonclinical Docs Specialist | QC & Publishing

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

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.