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Job Title: Documentation Specialist Location: Rahway, NJ Duration: 12 Months

Qualifications:

• High School Diploma with 10 years' experience in a related field and/or industry (required)
• Bachelor's degree and/or Certifications with 7 years' experience in a related field and/or industry (preferred)
• In-depth knowledge of Regulatory, CMC, Clinical and/or Preclinical within Animal Health or Pharmaceutical Industry
• Expertise in Document Management Systems (Veeva Vault preferred) and/or other repositories
• Knowledge of Office-related software (Microsoft Excel, Microsoft Word, Adobe Acrobat, etc.)
• Familiarity with EPA, FDA GxP, FDA CFR 21 Part 11, OECD GLP, USDA, and VICH regulations and guidelines
• Strong organizational skills, attention to detail, and ability to work independently and as part of a team
• Strong communication, organization, and writing skills with the ability to multi-task
• Ability to apply strategic and analytical thinking to a project
• Previous archiving, data management and migration experience
• Must work onsite a minimum of 3 days a week (Tuesdays and Wednesdays are mandatory days, 3rd day can be Monday or Thursday)

Responsibilities:

• Migrate and reclassify documents both paper and electronic originals, including external Regulatory-related documents from SharePoint sites, network shares, and electronic media
• Upload (scan when needed) and classify documents to be made viewable in Alexx
• Reclassify existing metadata on documents in Alexx from temporary storage to the production environment
• Review and identify document attributes and input corresponding metadata into Alexx
• Request Study Numbers, Products, and/or CRO Names using Alexx, when necessary
• Assure close working relationship with R&D stakeholders
• Review documents and metadata for clarity and completeness prior to sending for approval
• Assist with other Veeva Vault migration activities and other duties as assigned.