Job Description

Job Title: Manager, Medical Writing Operations

Location: Cambridge, MA 02142

Pay: $76 an hour or about 156,000 a year

Job Type: Long Term Contact

Overview:

The Manager, Medical Writing Operations supports Medical Writing functions to ensure the production of high-quality, submission-ready documents. This role oversees document quality, formatting, consistency, publishing, and archiving within central file systems. The position may also involve vendor oversight, staff training, and the development and maintenance of tools and training materials to enhance Medical Writing Operations.

Key Responsibilities:

• Collaborate cross-functionally to collect, compile, assemble, and publish Clinical Study Report (CSR) appendices.
• Perform electronic publishing QC, including checking hyperlinks and bookmarks, to ensure submission readiness.
• Format MS Word submission components according to style and regulatory requirements; troubleshoot formatting issues.
• Serve as a subject matter expert (SME) for format QC, submission readiness (protocols, IBs, CSRs), and document management systems.
• Ensure documents are properly stored and archived in EDMS and eTMF systems.
• Conduct content QC of medical writing documents (e.g., CSRs, IB clinical sections, NDA/MAA clinical sections, protocols).
• Support creation, maintenance, and updates of templates, style guides, and tools to meet global regulatory requirements.
• Perform administrative tasks to support projects and operational needs.
• Participate in the development and maintenance of internal best practices.
• Assist in the development, implementation, and maintenance of medical writing systems and software.
• Provide training to internal staff and external contractors/CROs.
• Support vendor oversight for medical writing operations activities.
• Update Medical Writing intranet pages as needed.
• Assist with CSR shells and preparation of in-text tables and figures under medical writer guidance.

Qualifications:

• Bachelor’s degree in a relevant scientific/technical field or equivalent experience.
• 4+ years of experience in biotech/pharma or CRO settings with expertise in document QC and electronic publishing in a regulatory environment.
• Strong understanding of health authority/ICH PDF and eCTD requirements.
• Experience with electronic document management systems.
• Proven ability to manage multiple projects in a fast-paced, deadline-driven environment.
• Detail-oriented with strong analytical, problem-solving, and flexible skills.
• Ability and confidence to learn new software tools.
• Proficient in MS Word, Excel, PowerPoint, Adobe Acrobat, and Windows.
• Experience with StartingPoint templates, SharePoint, EndNote, and Toolbox Pharma preferred.
• Alignment with Alnylam Core Values: Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, and Passion for Excellence.

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