Medical Writing Coordinator – Publisher II
AbbVie
full-time
Posted on:
Location Type: Remote
Location: Illinois • United States
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Salary
💰 $64,000 - $122,000 per year
About the role
- 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 styles 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 and 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 centralize 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.
Requirements
- A minimum of 4 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
- High School diploma required
- 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 interpret statistical analyses of clinical data
- Ability to work independently and as part of a team.
Benefits
- Medical/dental/vision insurance
- Paid time off (vacation, holidays, sick)
- 401(k)
- Short-term incentive programs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingclinical study reportsregulatory information management systemsdocument formattingquality reviewCommon Technical DocumenteCTD structurestatistical analysis interpretationmetrics trackingtraining document preparation
Soft Skills
interpersonal communicationorganizational communicationconflict managementcollaborationdetail orientedindependent workteamworkmentoringguidancestakeholder communication
Certifications
High School diploma