Medical Writing Coordinator/Publisher I

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 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 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 terminology across multiple therapeutic areas.
Detail oriented with a commitment to delivering high quality, accurate and compliant documentation.
Strong communication, collaboration, and organizational skills.
Ability to work independently and as part of a team. Ability to work independently and as part of a team.
Proficient skills and knowledge in Microsoft Office Products (Excel, OneNote, Outlook, PowerPoint, Project, SharePoint, Visio, Word) and Adobe in Windows operating system environment required. Proficient skills and knowledge in Microsoft document file formats (DocX) or other style file format tools, publishing software, and content management archival system(s) for eTMF/eSubmissions (Veeva Vault, CARA). Proficient skills and knowledge in reference management software (e.g., EndNote).

Employment type
Full-time

Work arrangement
Yes