Medical Writing Coordinator/Publisher II (Remote) - Strategic Medical Writing Operations

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:

• 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 styes 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, or Clinical Study Reports (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 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 strategic 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