Medical Writing Coordinator – Publisher II
Posted 2026-05-05
Remote, USA
Full-time
Immediate Start
- Job Description:
- Responsible for the formatting, report publishing and coordination of the Clinical Study Reports (CSR) Appendices for clinical and regulatory documents.
- Collaborates with the document author and tracks activities and performs detailed quality reviews.
- Imports and routes documents in the regulatory information management systems (RIMS).
- Formats documents to the defined styles and confirms consistency with the clinical and regulatory templates.
- Ensures the RIMS document properties and naming conventions are followed.
- Maintains strong knowledge of RIMS styles and formatting standards.
- Publishes documents in RIMS and maintains strong knowledge of RIMS system and publishing tools/software.
- Coordinates the CSR Appendices and confirms completeness of documents (e.g. Casebooks, Literature References) by obtaining, compiling, and organizing in the RIMS.
- Maintains strong knowledge of CSR and CSR Appendices and CTD structure.
- Contributes to the development, implementation, and maintenance of medical writing operations business processes.
- Acts as subject matter expert (SME) for the master file system and formatting report publishing and CSR Appendices to the strategic medical writing stakeholders.
- Effectively communicates deliverables needed to stakeholders.
- Must demonstrate good interpersonal and organizational communication skills, including conflict management skills.
- Assists in the management of the centralize mailbox.
- Tracks and maintains metrics and assists in the preparation and maintenance of training documents.
- Mentors and provides guidance and training to less senior strategic medical writing operations staff members.
- Requirements:
- A minimum of 4 years of relevant industry experience within medical writing in a global pharma, biotech, life science, or federal agency organization delivering medicines/therapies to a broad market across various therapeutic areas
- High School diploma required
- Background of organization and content of clinical documents and eCTD structure
- Knowledge of drug development and experience with Common Technical Document (CTD) content templates
- Outstanding written and oral communication skills, with a comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas
- Detail-oriented with a commitment to delivering high-quality, accurate and compliant documentation
- Strong communication, collaboration, and organizational skills
- Ability to interpret statistical analyses of clinical data
- Ability to work independently and as part of a team
- Benefits:
- Medical/dental/vision insurance
- 401(k) to eligible employees
- Paid time off (vacation, holidays, sick)
- Short-term incentive programs