Clinical Documentation Reviewer

Proclinical is currently recruiting for a Clinical Documentation Reviewer with a biopharmaceutical company located in North Chicago, IL.

Job Responsibilities:

• 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.

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