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Document Specialist - NJ
Ref No.: 18-05823
Location: Summit, New Jersey
Position Type:Full Time/Contract
Start Date / End Date: 09/04/2018 to 02/09/2019
Title is Document Specialist / QC Specialist.

Responsibilities will include, but are not limited to, the following:

1. 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).
2. Conducts QA/QC reviews of bookmarks and hyperlinks.
3. Reviews document content for accuracy, completeness and consistency against source documents/data.
4. Provides formatting of text and tables for documents authored by Clinical Pharmacology.
5. Communicates changes in the documents described above to authors, including CRO personnel, in an effective manner.
6. Provides instruction and guidance on templates, formatting, and publishing to CROs in accordance with the Client style guide.
7. Interacts with various departments focusing on document quality (for example, Regulatory Operations and Clinical Quality Assurance).
8. Supports Clinical Pharmacology personnel, as needed, for report management and provides electronic submission training and troubleshooting when necessary.
9. 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:
Bachelors 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).