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Medical Writer II
Ref No.: 17-06709
Location: Pearl River, New York
Start Date / End Date: 12/04/2017 to 06/03/2019
Job Description: Role Description
The Document Quality Reviewer will conduct document quality review (DQR) on the clinical components of documents authored by Vaccine Clinical Research & Development (VCRD). DQR includes clinical data checking, consistency checking, and editorial review according to Pharmaceutical and VCRD clinical guidelines.

Responsibilities
• Independently performs DQR of clinical components of assigned documents (e.g., protocols, clinical study reports, investigator brochures, manuscripts, summary documents, regulatory responses).
• Formally documents quality review findings for assigned documents. Identifies and immediately escalates significant findings.
• Participates in resolution of findings with the document authors, clinicians, and other team members, if necessary.
• Stores DQR documentation in the departmental electronic archive.
• Evaluates routine processes and procedures and makes recommendations on process improvements that could reduce recurring errors in documents.

Education
BS/BA degree (preferably in English/journalism/communications or biological science). Advanced degree with relevant medical editing or document quality review experience.

Experience
Minimum 7 years of experience in medical writing and/or DQR/QC of clinical documents in the pharmaceutical/healthcare industry. The candidate must have:
• Strong verbal, written, and interpersonal communication skills
• Understanding of scientific principles
• Knowledge of clinical research and medical terminology
• Ability to pay rigorous attention to detail while working rapidly and accurately
• Ability to edit documents for clarity
• Knowledge of Microsoft Office applications (MS Word, Excel, PowerPoint) and Adobe Acrobat

Technical Skills
• Analytical skills and understanding of statistics
• Project and process management skills
• Priority setting and problem solving

Work schedule

Work is assigned on an as-needed basis during standard work week (8 am – 5 pm, Monday – Friday). Project priorities occasionally necessitate work in the evening and over weekends.
Position Comments visible to MSP and Supplier: location can be Remote, Pearl River or Collegeville PA
old request number 8656-1