Medical Writer

  • location: North Chicago, IL
  • type: Contract
  • salary: $19.04 - $22.40 per hour
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job description

Medical Writer

job summary:
Medical Writing Word Processing Coordinator I

Job Summary

The Medical Writing Word Processing Coordinator is responsible for formatting, proofing, and completion of Clinical Protocols, Clinical Study Reports, Investigator's Brochures, and other related clinical regulatory documents. Provides document formatting support to Medical Writing, Clinical, and, other functional areas, 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 eSubmissions standards so that the documents created in MS Word correctly render to PDFs.

 
location: North Chicago, Illinois
job type: Contract
salary: $19.04 - 22.40 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
Job Responsibilities

  • 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.
 
qualifications:
Education & Qualifications

  • Bachelor of Science or Bachelor's degree in English or Communications
  • Strong MS Word experience required
Preferred Requirements

  • Outlook, Excel, PowerPoint is preferred
  • 1+ year relevant pharmaceutical industry experience in a related area such as medical writing, quality, regulatory, clinical research, or product support/Research & Development desired.
 
skills: Editing, MS-WORD, QC Review
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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