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