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