Medical Writing Operations Manager

Manager, Medical Writing Operations

The Manager, Medical Writing Operations supports Medical Writing functions to ensure the delivery of high‑quality, submission‑ready documents. Core responsibilities include document quality review, formatting and consistency checks, electronic publishing, and archiving within centralized file systems. The role may also contribute to vendor oversight, training, and the development and maintenance of tools and training materials for Medical Writing Operations.

Key Responsibilities

Document Preparation & Quality Control

Collaborate cross‑functionally to collect, compile, assemble, and publish CSR appendices

Perform electronic publishing QC (e.g., hyperlinks, bookmarks) to ensure submission‑ready compliance

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

Conduct content QC of medical writing documents, including CSRs, IB clinical sections, NDA / MAA clinical sections, and protocols

Document Management & Systems

Ensure proper storage and archiving of documents in EDMS and eTMF systems

Support development, implementation, and maintenance of medical writing systems and software

Assist with updates to Medical Writing intranet pages

Support creation, maintenance, and updates of templates, style guides, and tools to meet global regulatory requirements

Operational & Cross‑Functional Support

Perform administrative tasks to support project and operational needs

Participate in the development and maintenance of internal best practices

Assist with training internal staff and external contractors / CROs

Support vendor oversight for medical writing operations activities

Assist with CSR shells and / or preparation of in‑text tables and figures under medical writer guidance

Qualifications

Education & Experience

Bachelor’s degree in a relevant scientific or technical field, or equivalent experience

4+ years of biotech / pharma or CRO experience in document QC and electronic publishing within a regulatory environment

Technical Skills

Strong understanding of health authority / ICH PDF and eCTD requirements

Experience with electronic document management systems

Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Windows

Ability and confidence to learn new software tools

Preferred : Experience with StartingPoint templates, SharePoint, EndNote, and Toolbox Pharma

Professional Skills

Proven ability to manage multiple projects in a fast‑paced, deadline‑driven environment

Exceptional attention to detail with strong analytical and problem‑solving skills

Flexible, adaptable, and able to work effectively across teams

Core Values Alignment

Commitment to People

Fiercely Innovative

Purposeful Urgency

Open Culture

Passion for Excellence

Seniority level

Mid‑Senior level

Employment type

Contract

Job function

Writing / Editing

Pharmaceutical Manufacturing

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