The Strategic Medical Writing Operations Team is dedicated to delivering high-quality, scientifically accurate, and strategically aligned clinical and regulatory documentation that supports AbbVie's mission to transform the standard of care. Our team serves as a critical link between research, development, and regulatory submissions, ensuring clarity and compliance in all clinical and regulatory documents. We strive to innovate and enhance the processes of medical writing through cross-functional collaboration, agile methodologies, and the integration of cutting-edge technology, driving forward AbbVie's commitment to improving patient outcomes worldwide.

Responsibilities:

• Defines scope of formatting, report publishing, or 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 and meet required timelines. 
• Ensure completeness of information in CSR Appendices.  Maintain strong knowledge of CSR/CSR appendices organization and content and knowledge of 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.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required