Senior Nonclinical Documentation Associate

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 document ion 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 experience4+ 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 Starting Point templates, Sharepoint and DXC Toolbox is a plus Familiarity/general understanding of global regulatory requirements, including but not limited to, 21 CFR 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 revolutionary approach…