Clinical Documentation Reviewer
Proclinical is currently recruiting for a Clinical Documentation Reviewer with a biopharmaceutical company located in North Chicago, IL.
- Format, proof, and complete clinical protocols, clinical study reports, investigator brochures, summaries, and other related clinical documents.
- Provides regulatory document formatting support to the Medical Writing, Clinical, and Pharmacovigilance Teams, ensuring successful preparation of high-quality submission-ready documents.
- Ensures completion of work to meet multiple client deadlines.
- Ensures styles and formatting are consistent with defined eSubmission standards so that the documents created in MS Word correctly render to PDF.
- Proofreads documents for accuracy and consistency.
- Coordinates and communicates with other word processing team members for consistency for all documents.
- Imports and routes documents in the submission system ensuring proper naming conventions and document properties. Creates and updates clinical templates as directed by the Submission Templates & Tools Team (STaTT).
- Provide regulatory document support to the medical writing teams, ensuring successful preparation of high quality submission-ready documents.
- Provide expertise in the management and coordination of Clinical Study Report (CSR) casebooks and other appendix 16 documents ensuring timely completion, completeness, and formatting accuracy.
- Assist in the compilation and delivery of literature references into the eSubmission system.
- Perform electronic navigation quality control on these documents and managing workflows.
- Act as eSubmission system peer advisor/subject matter expert (SME) for assigned clinical team(s), including downloading documents from eSubmission system in support of audit/inspection requests. Acting as subject matter expert on master file content management system.
- Participate in process and operational improvement activities (e.g., bot).
- Ensures all electronic document deliverables are processed and completed in alignment with timelines.
- Accountable for meeting the main objectives of assigned word processing projects within established timelines and with an appropriate quality level.
- Ensures document styles and formatting are consistent with defined eSubmissions standards, so that documents created in MS Word are correctly rendered to PDFs.
- Confirms formats and styles are consistent with those in the clinical regulatory templates, when applicable.
- Accountable for providing services and results on time, accurately and consistent with expectations.
- Populates document properties and ensures correct naming conventions are used per the eSubmissions System file naming conventions.
- Accurately and timely maintains document tracking for all documents.
- Processes, proofreads, verifies and manages various clinical regulatory documents, ensuring they are submission-ready for publishing with an appropriate level of accuracy and consistency.
- Performs literature searches ansd ensures literature citations are correct.
Skills and Requirements:
- Bachelor of Science or Bachelor's degree in English or Communications will be considered.
- 5+ years relevant pharmaceutical industry experience in a related area such as medical writing, quality, regulatory, clinical research, or product support/Research & Development desired.
- Maintains knowledge of eSubmissions styles and formatting standards.
- Must continually train/be compliant with all current industry requirements as they relate to regulatory submissions, including electronic submission/approval standards.
- Participates in process improvement activities.
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.