Documentation Specialist Job

Documentation Specialist III needed for a contract opportunity with Yoh's client located in Swiftwater, PA

The Big Picture - Top Skills You Should Possess:

- Requires strong experience in formatting MS word documents
- Experience with Acrobat professional, ISI toolbox or Documentum is a plus
- Ability to edit and format clinical documents for consistency and compliance

What You'll Be Doing:

- Support Medical Writers in the preparation of CSR appendices, request and prepare bibliographic references
- Assemble, publish and QC Clinical Study Reports (CSR) and other documents as required using established tools, processes, standards and guidelines for submission readiness
- Provide support to Medical Writing Partnership coordinator in preparation of WOs, AEDs etc to outsource work to Medical Writing CRO
- File appropriate WOs, specifications to the TMF
- Manage training records for partnerships and other support documentation
- Track and renew system accesses for partnership; be point of contact with IS when necessary to trouble shoot technical and access issues
- Manage the Inspection Readiness e-room for MW&T and ensure that all documents and filed and up-to-date
- Assist with preparedness activities for Submission related inspection

What You Need to Bring to the Table:

- Previous experience in a documentation specialist role
- Organizational skills
- Strong Interpersonal and communication skills
- High-school diploma is required

What are you waiting for? Opportunity is Calling, Apply Now!

Recruiter: Lori Heckathorn

Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more !

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

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Ref: 1057921

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