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Document Specialist / QC Specialist
Ref No.: 18-11916
Location: Summit, New Jersey
Position Type:Contract
Start Date / End Date: 09/04/2018 to 02/09/2019
Sunrise System Inc. is currently looking for Document Specialist / QC Specialist in Summit, NJ with one of our top client.
Job Title: Document Specialist / QC Specialist
Job Id: 18-11916
Location: Summit, NJ 07901
Duration: 5 months
Position Type: Hourly contract Position (W2 only)
 
Responsibilities will include, but are not limited to, the following
  • Support Clinical Pharmacology trial managers, pharmacologists, and pharmacokineticists by performing the Quality Control (QC) review (of content), formatting, and publishing/maintenance of key documents (for example, protocols, clinical study reports, manuscripts, investigator brochures).
  • Conducts QA/QC reviews of bookmarks and hyperlinks.
  • Reviews document content for accuracy, completeness and consistency against source documents/data.
  • Provides formatting of text and tables for documents authored by Clinical Pharmacology.
  •  Communicates changes in the documents described above to authors, including CRO personnel, in an effective manner.
  • Provides instruction and guidance on templates, formatting, and publishing to CROs in accordance with the Client style guide.
  • Interacts with various departments focusing on document quality (for example, Regulatory Operations and Clinical Quality Assurance).
  • Supports Clinical Pharmacology personnel, as needed, for report management and provides electronic submission training and troubleshooting when necessary.
  • Assists with compilation of monthly report and/or other key tasks for Clinical Pharmacology. 10. Able to demonstrate and promote Client Values and behaviors. 
Skills/Knowledge Required
  • Basic knowledge of document management/quality control, including strong familiarity with clinical documents (for example, protocols, clinical study reports, ICFs, manuscripts).
  • Basic knowledge of clinical development and ICH/GCP preferred.
  • Must have strong organization and interpersonal skills, be detail-oriented, be a team player and be willing to work in an environment where individual initiative and accountability to projects are required.
  • Must be able to work with limited day-to-day supervision.
  • Must have a general knowledge of SOP standards, and be able to follow SOPs/WPs.
  • Must have basic knowledge of computer applications including electronic document management systems such as Documentum or eSubmission.
  • Must have basic knowledge of document formatting/editing/publishing techniques/tools such as TRS Toolbox (formerly ISI Toolbox) and all if its features (for example, creating bookmarks and hyperlinks) 
Must have:
  • Bachelor’s Degree / Life Sciences or related field, or equivalent in industry experience.
  • Minimum 2 years’ document management/QC review (content QC) experience.
  • Minimum 2 years’ experience in the Pharmaceutical industry preferred.
  • Strong PC skills to include: Microsoft Office Suite (Word, Excel, Outlook, PowerPoint). 
Contact
Praful Prasanna
Email: Praful.P@sunrisesys.com | Direct: (732) 272 0326
Or
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: sourabh@sunrisesys.com