1 Year Contract – NJ
Global Regulatory Department
Perform daily document management activities such as Review, Processing, Filing of Clinical Trial Master File documents. Quality Control review of Regulatory Documents. Coordinate with eTMF vendor for TMF set-up and processing of TMF documents. Development of user manuals. Scanning and storage of Clinical Operation documentation such as CRFs and Trial Master files.
Must 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. Excellent written, verbal, and interpersonal communication skills.
Bachelor’s Degree preferred. 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
Company offers very competitive hourly rate.