Medical Affairs - Medical Writing Operations Manager

TalentBurst; Cambridge; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading recruitment agency in the UK is seeking a Medical Writing Operations Manager with a strong background in therapeutic areas. You will manage document quality control, ensure regulatory compliance, and support the creation of submission-ready materials. The ideal candidate has over 4 years of experience in biotech or CRO, proficiency in document management systems, and strong skills in MS Word and electronic publishing. This role offers a collaborative environment focused on high-quality documentation.

Qualifications

• 4+ years of biotech/pharma or CRO experience in document QC and electronic publishing.
• Strong understanding of health authority/ICH PDF and eCTD requirements.
• Proficient in MS Word, Excel, and PowerPoint.

Responsibilities

• Collaborate across functions to publish CSR appendices.
• Perform content QC of medical writing documents.
• Support updates to Medical Writing intranet pages.

Skills

Document quality review

Electronic publishing QC

MS Word

Analytical skills

Problem-solving skills

Education

Bachelor's degree in a relevant scientific/technical field

Tools

SharePoint

EndNote

Toolbox Pharma

Adobe Acrobat

Job description

Medical Affairs – Medical Writing Operations Manager (11 months) – Cambridge, MA

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 Starting Point templates, SharePoint, EndNote, and Toolbox Pharma preferred.

Alignment with Core Values: Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, and Passion for Excellence.