Medical Writing Operations Manager

Medical Writing Operations Manager - Contract - Cambridge MA

Be the backbone of innovation and join a leading pharmaceutical company to help keep life-changing science moving forward!

Proclinical is seeking a Medical Writing Operations Specialist to support the creation, quality review, and management of submission-ready documents.

Primary Responsibilities:

This role involves ensuring document consistency, formatting, and compliance with regulatory standards, as well as contributing to operational excellence within medical writing functions.

Skills & Requirements:

• Background in a relevant scientific or technical field, or equivalent experience.
• Experience in document QC and electronic publishing within a regulatory environment.
• Strong understanding of health authority, ICH, PDF, and eCTD requirements.
• Familiarity 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 adaptability skills.
• Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Windows.
• Exposure to tools like StartingPoint templates, SharePoint, EndNote, and Toolbox Pharma is preferred.

The Medical Writing Operations Manager's responsibilities will be:

• Collaborate across teams to collect, compile, and publish Clinical Study Report (CSR) appendices.
• Perform quality control (QC) checks on electronic publishing, including hyperlinks and bookmarks, to meet submission guidelines.
• Format MS Word documents according to style and regulatory requirements, troubleshooting formatting issues as needed.
• Act as a subject matter expert (SME) for format QC, submission readiness protocols, Investigator Brochures (IBs), CSRs, and document management systems.
• Ensure proper storage and archiving of documents in electronic document management systems (EDMS) and electronic trial master file (eTMF) systems.
• Conduct content QC for medical writing documents, such as CSRs, IBs, clinical sections of NDAs/MAAs, and protocols.
• Support the creation, maintenance, and updates of templates, style guides, and tools to align with global regulatory requirements.
• Perform administrative tasks to support projects and operational needs.
• Contribute to the development and maintenance of internal best practices.
• Assist in the implementation and upkeep 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.

Compensation:

• $70 to $77 per hour.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at [email protected]

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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