Defines scope of formatting, report publishing and Clinical Study Reports (CSR) Appendices activities with the document author. Coordinate and track activities and perform detailed quality reviews. Import and route documents in the regulatory information management systems (RIMS).
Ensure document format and styles are consistent with the defined in RIMS and are consistent with the clinical and regulatory templates. Ensure document properties and naming conventions are used. Maintain strong knowledge of RIMS styes and formatting standards.
Ensures all documents are published in RIMS content management system meet required timelines. Maintain strong knowledge of RIMS and publishing tools/software.
Confirm completeness of documents (e.g. Casebooks, Literature References) by obtaining, compiling, and organizing in the regulatory information management system (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, or Clinical Study Reports (CSR) Appendices to the 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 centralized mailbox. Tracks and maintains metrics and assists in the preparation and maintenance of training documents.
Mentors and provides guidance and training to less senior medical writing operations staff members.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.
High School diploma required. Note: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.
A minimum of 2 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.
Background of organization and content of clinical documents and eCTD structure. Knowledge of drug development and experience with Common Technical Document (CTD) content templates.
