Medical Affairs - Medical Writing Operations Manager - Contract
TalentBurst, Inc.
Cambridge, MA
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
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
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About the Company
TalentBurst, Inc.
For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.
Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!