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Documentation Specialist Job
Eingestellt von Yoh
Gesuchte Skills: Support, Client
Projektbeschreibung
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, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.
J2W: PROF
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Ref:
SFSF: PROF
Projektdetails
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Einsatzort:
Swiftwater, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges