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location: North Chicago, Illinois
job type: Contract
salary: $30.00 - 33.95 per hour
work hours: 9 to 5
Additional responsibilities may include the following:
- The Senior Word Processing Coordinator II is responsible for formatting, proofing, and completion of 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).
- Providing regulatory document support to the medical writing teams, ensuring successful preparation of high quality submission-ready documents.
- Providing expertise in the management and coordination of Clinical Study Report (CSR) casebooks and other appendix 16 documents ensuring timely completion, completeness, and formatting accuracy.
- Assisting in the compilation and delivery of literature references into the eSubmission system. Performing electronic navigation quality control on these documents and managing workflows.
- Acting 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.
- 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.
- Processes, proofreads, verifies and manages various clinical regulatory documents, ensuring they are submission-ready for publishing with an appropriate level of accuracy and consistency.
- Communicates regularly with colleagues and management regarding timelines and conflict to timelines for word processing requests, eSubmissions issues, and document completion dates.
- Provides ongoing support for Medical Writing, Clinical, and, other functional areas; acts as a liaison between eDocs support and Medical Writing as needed.
- Responsible for effective communication among team members.
- 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.
- Ensures literature citations are correct. Performs literature searches.
- 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.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.