Advantage Technical
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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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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