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Regulatory Documentation Specialist

Company: Eisai, Inc (Starpoint)
Location: Ridgewood
Posted on: September 17, 2020

Job Description:

Our Pharma client is looking for a Regulatory Documentation Specialist
for their NNJ offices.


The Regulatory Documentation Specialist will:



Perform daily Trial Master File management activities such as Review, Processing, Filing of Clinical Trial Master File documents, to ensure the TMF is Inspection Ready.
Conduct Quality Control reviews of TMF Documents. Coordinate with eTMF vendor for TMF set-up and processing of TMF documents and conduct eTMF query resolution.
Assist in the archiving of TMF documents; this may include shipping, retrieval, and tracking of documents approved for archiving to off-site storage; Maintain electronic logs which contain the location of study documents.
Development/Contribution toward user manuals / Best Practice guides
Have strong document management skills, including experience with review of Regulatory Documents, be detail oriented, organized, quality driven and able to work in a team environment under tight deadlines.
Have a knowledge/understanding of TMF requirements and technologies to support document collection and archiving; eTMF experience preferred.
Have a working knowledge of Microsoft Word, Microsoft Excel, Adobe Acrobat, and electronic document management systems, preferably Documentum. Agility with ClinOps databases preferred.
Basic knowledge of CFR, GCP & ICH Guidelines.
2+ plus years Pharma experience (includes CRO / Vendor experience)
Have knowledge and understanding of DIA TMF Reference model
Demonstrate excellent written, verbal, and interpersonal communication skills.
Bachelor's Degree preferred.


For more info on this & other exciting roles please contact me

MARC LEVINE



C: 914-262-5142


E: marc.levine@yoh.com


PandoLogic.Category: Technology, Keywords: Documentation Specialist

Keywords: Eisai, Inc (Starpoint), New York , Regulatory Documentation Specialist, Other , Ridgewood, New York

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