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

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

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 ope