Integrated Resources, Inc.
Medical Writing Operations Manager
Integrated Resources, Inc., Cambridge, Massachusetts, us, 02140
Medical Writing Operations Manager
Location
Cambridge, MA 02142
Duration 12 Months+ (Possible Extension)
Pay Range $65 - $72.65/hr. on w2
Job Summary 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 Client Core Values: Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, and Passion for Excellence
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Duration 12 Months+ (Possible Extension)
Pay Range $65 - $72.65/hr. on w2
Job Summary 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 Client Core Values: Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, and Passion for Excellence
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