Medical Writer

Highly Competitive Salary
  1. Permanent
  2. Medical Communications, Medical Writing, Project Management
  3. United States
North Chicago, USA
Posting date: 12 Jan 2021
MA.JJ.34975

Proclinical is currently recruiting for a Medical Writer with a biopharmaceutical company located in North Chicago, IL.

Job Responsibilities:

  • Determines scope of QC review with the document author and the source documents and/or data required (in addition to utilizing any applicable checklist).
  • Conducts independent quality review of documents by checking against source (documents and/or data) to ensure that the results presented are accurate (emphasis on checking the numbers/data in the text and in-text tables against the final statistical tables, listings, and graphs).
  • Deliver documented quality review comments/checklist to document author through resolution.
  • Ensures QC review documentation from all applicable functional areas is completed and uploaded to the TMF per the established business processes and procedures.
  • Maintains strong knowledge of clinical regulatory documents requiring QC as well as business processes and procedures for these documents. Demonstrates strong attention to detail and a high level of quality, consistency, and accuracy in work effort.
  • Accountable for meeting the main objectives of the assigned projects/roles and responsibilities within established timelines and with an appropriate quality level.
  • Drives the QC of clinical regulatory documents to timely completion.
  • Accountable to Senior Manager, Medical Writing. Exhibits a moderate level of technical competency and requires a low level of counsel and guidance.
  • Mentors and provides guidance/training to less senior MW QC staff as applicable.
  • Expedient escalation of issues to management is essential and may have a direct impact on the ability to meet project timelines.
  • Daily interaction with Medical Writers and/or Medical Writing managers as well as interface/communication with applicable cross-functional areas. Communicates and provides deliverables to Medical Writers, Medical Writing managers, and others as applicable.

Skills and Requirements:

  • Bachelor's degree (BA/BS) required.
  • 2-4 years relevant pharmaceutical industry experience in medical writing, clinical research, quality, or related area such as regulatory or product support.
  • Experience in quality review of clinical regulatory documents.
  • Experience in being flexible with changing workload that requires prioritization and planning to support immediate/urgent business needs.
  • Proficient experience in use of MS Office (e.g., Word, Excel, Outlook, PowerPoint) and Must be familiar with ICH and GCP Guidelines.
  • Must demonstrate good interpersonal and organizational communication skills.
  • Adobe Acrobat

If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at 267-297-3257.

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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