Document Specialist

Location: Summit, New Jersey Salary: competitive
Sector: Pharma & Biotech, Quality & Supply Chain, Clinical Research, Medical Affairs, R&D, Quality Assurance (QA), Operations, Pharmacovigilance, Regulatory Affairs Type: Contract

Position: Document Specialist

Duration: 5 Months, STRONG possibility of temp to perm

Location: Summit, New Jersey

Responsibilities of Document Specialist:

  • QC review, formatting, and publishing of trial documents during the authoring process, including text and tables
  • Conduct QA/QC review of bookmarks and hyperlinks
  • Instructs and guides vendors on expected formatting, templates and publishing
  • Supports Clinical pharmacology personnel for report management and electronic submission training and trouble shooting
  • Assists with compilation of monthly report

Requirements of Document Specialist:

  • Experience preforming content QC review & formatting of core clinical trial documents
  • Basic knowledge of document management, including strong familiarity with clinical documents
  • Must have a strong knowledge of SOP standards and be able to abide by Sops/WPs
  • Basic knowledge of computer systems including Documentum or eSubmission
  • Bachelors degree in life sciences or related, or industry equivalent
  • Minimum 2 years preforming a QC/document management function
  • Minimum 2 years in the pharmaceutical industry

Selected applicant for document specialist role must be able to work on site in Summit, New Jersey for the duration of the contract

As a temporary W2 employee of Real Staffing, you have the option of enrolling into the following offered benefits: medical, dental, vision, 401K, voluntary short term/long term disability and voluntary life insurance.

Sthree US is acting as an Employment Business in relation to this vacancy.