Search Jobs
Medical Writing Operations Manager
675 Kendall St Cambridge, MA 2147 US
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
- 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 company Core Values: Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, and Passion for Excellence
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Share This Job:
Related Jobs:
About Cambridge, MA
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.