Job Description
- 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 perform detailed quality reviews
- Import and route 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
- Maintain strong knowledge of RIMS styles and formatting standards
- Publishes documents in RIMS and maintain strong knowledge of RIMS system and publishing tools/software
- Coordinates the CSR Appendices and confirm completeness of documents (e.g. Casebooks, Literature References) by obtaining, compiling, and organizing in the RIMS
- Maintain 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, 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
- Paid time off (vacation, holidays, sick)
- 401(k)
- Short-term incentive programs
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