Medical Writing Operations Manager-624628

Planet Pharma; Cambridge (MA); On-site; USD 89,544 - 99,876; Part time

Job summary

A leading pharmaceutical company is looking for a Medical Writing Operations Manager to ensure high-quality, submission-ready documents. The role includes reviewing and formatting documents, supporting vendor oversight, and maintaining documentation systems. Candidates should have a Bachelor's degree in a relevant field and at least 4 years of regulatory document experience in biotech or pharma. The position is contract-based and offers a fast-paced work environment that values innovation and excellence.

Qualifications

• 4+ years of experience in biotech/pharma or CRO document QC within a regulatory environment.
• Strong understanding of health authority/ICH PDF and eCTD requirements.
• Experience with electronic document management systems.

Responsibilities

• Collaborate across functions to publish CSR appendices.
• Perform electronic publishing quality control to meet guidelines.
• Support the development and maintenance of medical writing systems.

Skills

Document quality review

Electronic publishing QC

Formatting and consistency

Analytical skills

Problem-solving

Multiple project management

Proficient in MS Word

Education

Bachelor’s degree in a relevant scientific/technical field

Tools

MS Word

Adobe Acrobat

Excel

PowerPoint

SharePoint

Job description

Medical Writing Operations Manager

Salary range: $65.00/hr - $72.50/hr

Seasoned Recruiter and Candidate Advocate 708-286-1085 [e-mail]

The Manager, Medical Writing Operations provides support to Medical Writing functions to ensure high-quality, submission-ready documents. Responsibilities include document quality review, formatting and consistency, publishing, and archiving within central file systems. The role may also support vendor oversight, training, and the development and maintenance of tools and training materials for Medical Writing Operations.

Key Responsibilities

• Collaborate across functions to collect, compile, assemble, and publish CSR appendices
• Perform electronic publishing QC, including hyperlinks and bookmarks, to meet submission-ready guidelines
• Format MS Word submission components per style and regulatory requirements; troubleshoot formatting issues
• Serve as SME for format QC, submission readiness (protocols, IBs, CSRs), and document management systems
• Ensure documents are stored and archived appropriately in EDMS and eTMF systems
• Perform content QC of medical writing documents (eg, 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 development and maintenance of internal best practices
• Support development, implementation, and maintenance of medical writing systems and software
• Assist with training of internal staff and external contractors/CROs
• Support vendor oversight for medical writing operations activities
• Support updates to Medical Writing intranet pages as needed
• Assist with CSR shells and/or preparation of in-text tables and figures under medical writer oversight

Qualifications

• Bachelor’s degree in a relevant scientific/technical field or equivalent experience
• 4+ years of biotech/pharma or CRO experience in document QC and electronic publishing within 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 flexibility skills
• Ability and confidence to learn new software tools
• Proficient in MS Word, Excel, PowerPoint, Adobe Acrobat, and Windows • Exposure to StartingPoint templates, SharePoint, EndNote, and Toolbox Pharma preferred
• Alignment with company Core Values: Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, and Passion for Excellence

Seniority Level

• Mid-Senior level

Employment Type

• Contract

Job Function

• Writing/Editing