Medical Writer Word Processing Coordinator III

  • location: North Chicago, IL
  • type: Contract
  • salary: $30 - $33.95 per hour
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job description

Medical Writer Word Processing Coordinator III

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: $30.00 - 33.95 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • 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.
 
qualifications:
  • 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.
 
skills: MS-WORD
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.

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