Medical Writing Operations Manager

Enter Job Description...

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 Alnylam Core Values : Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, and Passion for Excellence

EEO Employer

LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.