Clinical Documentation Specialist
Proclinical is currently recruiting for a Clinical Documentation Specialist with a biopharmaceutical company located in North Chicago, IL.
- Implements selected activities (such as document workflows, tracking, and electronic QC) associated with electronic document-related activities for regulatory documents.
- Communicates 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.
- Ensures all electronic document deliverables are processed and compiled in alignment with timelines.
- Manages workflows for review/approval in the eSubmission system.
- Coordinates, tracks completion, and manages acceptance of casebooks and appendix documents.
- Manages eDoc tracking spreadsheet.
- Prepares documents for submission to RIC, Data Management, and Regulatory Affairs.
- Manages process and performs electronic QC of casebooks and appendices.
- Confirms completeness of information in appendix documents (e.g., CSR).
- Acts as interface to resolve issues associated with casebooks and appendices through ongoing communication with the clinical team. Maintains strong knowledge of casebook and appendices organization and content.
- Compiles and organizes literature references for regulatory documents. Performs literature searches.
- Acts 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.
- Holds team members accountable to agreed-upon deliverables and dates.
- Coaches and mentors more junior Medical Writing Coordinators.
- Participates in process improvement activities.
- Serves as an expert on the electronic document system in support of the clinical team.
- Serves 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 Zachary Hines at 215-531-6914.
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.