Medical Writing Coordinator

Highly Competitive Salary
  1. Permanent
  2. Clinical Research Associate (CRA), Project/Study Manager (CSM/CPM)
  3. United States
North Chicago, USA
Posting date: 18 Jun 2020
CR.SR.30043

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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