Medical Writing Coordinator​/Publisher

Company Description

About Abb Vie

Abb Vie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on Linked In, Facebook, Instagram, Xand You Tube.

The Medical Writing Coordinator/Publisher I part of the Strategic Medical Writing Operations Team is dedicated to delivering high-quality, scientifically accurate, and strategically aligned clinical and regulatory documentation that supports Abb Vie'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 Abb Vie's commitment to improving patient outcomes worldwide.

Responsibilities:

• 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.
• Outstanding written and oral communication skills, with a comprehensive knowledge of medical and scientific…