job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you!
location: North Chicago, Illinois
job type: Contract
salary: $29.00 - 33.95 per hour
work hours: 9 to 5
- 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).
Additional responsibilities may include the following:
- 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.
- Participating in process and operational improvement activities (e.g., bot).
- 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.
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.