Medical Writing Coordinator

Proclinical is currently recruiting for a Medical Writing Coordinator with a biopharmaceutical company located in North Chicago, IL.

Job Responsibilities:

• Implement selected activities (such as document workflows, tracking, and electronic QC) associated with electronic document-related activities for regulatory documents
• Communicate deliverables, electronic document process, and durations associated with these activities to the Medical Writing Manager, Clinical Project Management, and other functional areas such as Publishing, etc., as required
• Ensure all electronic document deliverables are processed and compiled in alignment with timelines
• Manage workflows for review/approval in the eSubmission system
• Coordinate, track completion, and manage acceptance of casebooks and appendix documents
• Manage eDoc tracking spreadsheet
• Prepare documents for submission to RIC, Data Management, and Regulatory Affairs
• Manage process and performs electronic QC of casebooks and appendices
• Confirm completeness of information in appendix documents (e.g., CSR)
• Act as interface to resolve issues associated with casebooks and appendices through ongoing communication with the clinical team. Maintain strong knowledge of casebook and appendices organization and content
• Comply and organizes literature references for regulatory documents. Perform literature searches.
• Act as eDocs Peer Advisor/Subject Matter Expert for assigned clinical teams. Must continually train/be compliant with all current industry requirements as they relate to regulatory submissions, including electronic submission/approval standards. Responsible for effective communication among team members.
• Hold team members accountable to agreed-upon deliverables and dates
• Coach and mentor more junior Medical Writing Coordinators
• Participate in process improvement activities
• Serve as an expert on the electronic document system in support of the clinical team
• Serve as subject matter expert on cross-functional teams supporting the implementation of new regulatory initiatives impacting the compilation of CSRs (i.e. eCTD)

Skills and Requirements:

• Bachelor of Arts or Bachelor of Science or Associates Degree preferred; equivalent experience considered
• 2-3+ years in clinical research or related field
• Strong knowledge of organization and content of clinical documents

If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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