Medical Writing Coordinator II
Proclinical is currently recruiting for a level two Medical Writing Coordinator role with a leading pharmaceutical company in North Chicago, IL. Successful candidates will provide expertise in the management and coordination of casebooks, and other appendix 16 documents ensuring timely completion, completeness, and formatting accuracy.
- 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 manages 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. Maintains strong knowledge of casebook and appendices organization and content.
- Compile and organize literature references for regulatory documents. Performs 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 mentors 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nadine Rucci at (+1) 215-531-5281 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.