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Regulatory Documentation Specialist Job
Eingestellt von Yoh
Gesuchte Skills: Adobe, Affiliate
Projektbeschreibung
THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:
- Regulatory submissions
- Publishing tools (ISI Toolbox, Documentum)
- Clinical Documentation
WHAT YOU'LL BE DOING:
- Perform the preparation of regulatory submissions in paper format. The ability to prepare submissions in electronic format is a plus.
- Provide assistance with preparation, format, update, and proofreading of various clinical and regulatory documents to ensure quality for FDA submissions as well as in house and affiliate/partner distribution
- Review and provide feedback on investigational site start up packages to allow the shipment of investigational drug to sites.
- Update department's lists and databases, transfer documents into or download documents from Documentum® File Systems
- Process Safety Letter correspondence and other routine submissions.
WHAT YOU NEED TO BRING TO THE TABLE:
- Full understanding and quality check of FDA submission documents for completeness and adherence to Regulatory and Company standards, and complete understanding of the FDA's extensive Document Management Standards and Guidelines
- High School Diploma or equivalent required; College experience is a plus
- Experience in preparation of FDA submissions within a Pharmaceutical environment, knowledge of both FDA and ICH guidelines and the drug development process is a big plus
- Must be self sufficient, able to prioritize, possess a sense of urgency, detail oriented, good interpersonal skills, have an ability to effectively communicate written and orally with peers and management.
- Strong knowledge of Microsoft Office® suite, Adobe Acrobat®, and scanning applications is required.
BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:
- Safety Data Reporting
GET HIRED, APPLY NOW!
RECRUITER: Tonya Allen
Yoh, a DayJ2W: CLINICAL
MONJOB J2WNECLIN
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
Edison, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Marketing/Vertrieb, Medien/Design