Clinical Documentation Specialist Job

CLINICAL DOCUMENTATION SPECIALIST needed for a CONTRACT opportunity with Yoh's client located in BRIDGEWATER, NJ.

WHAT YOU'LL BE DOING:

- Coordinating and collecting supporting documents for clinical study reports from internal teams
- Make documents available to external vendors for purposes of submission readiness and publishing by the vendor or perform the publishing activities in house
- Manage document life cycle from initiation through electronic approval
- Create study dictionaries within the Documentum system, initiate/create documents in the Documentum system, perform submission readiness of the documents concentrating on styles, format, structure, navigation, adherence to processes, correct template usage, etc.
- Perform independent QC on published reports
- Complete appropriate checklists for the activities around quality of publishes and submission readiness of source documents
- Coordinate activities with external vendors on assignments, timelines, feedback using the required tracking tools and methods of communication that support the process
- Manage and track document hand-offs
- Review documents delivered by vendor for adherence to company standards and to evaluate and track the quality delivered
- Report findings as needed to allow for improved quality of deliverables
- Updates to documents to support submission readiness activities in Word source documents and PDF documents when vendor is not available to manage
- Order literature references to support clinical documents

WHAT YOU NEED TO BRING TO THE TABLE:

- BA, AA or technical degree with two to five (2-5) years in document management preferably in the pharmaceutical industry
- Experience in ISI toolbox for submission readiness activities such as bookmarks, navigation, global pagination, etc.
- Strong Word experience for managing styles, formats, TOC, references
- Understanding of regulatory requirements on document structure and navigation
- Understanding of eCSR structure and content
- Experienced in document management systems such as Documentum
- Strong written and verbal communication skills
- Ability to organize and prioritize and capable of working with external vendors, managing and prioritizing assignments
- Work collaboratively across different cultures, time zones and experience levels
- CoreDossier or Insight publishing preferred but not required.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER:Krista Leach

Yoh, a DayCLINICAL

TAX TERM: CON_W2

MONJOB J2WMIDATL

Ref:

SFSF: LS