Job Title: Documentation Specialist - III (Senior)
Location: Madison, NJ
Duration: 12 months
This role will require minimum 3 days onsite (Tuesdays and Wednesdays are mandatory days, 3rd day can be Monday or Thursday).
Qualifications: • Required: High School Diploma with 10 years’ experience in a related field and/or industry. • Preferred: Bachelor’s degree and/or Certifications with 7 years’ experience in a related field and/or industry. • Knowledge of scientific R&D documents within Animal Health or Pharmaceutical Industry is required. • Must have in-depth knowledge of Regulatory, CMC, Clinical and/or Preclinical to be able to read, categorize and comprehend study related documentation. • Expertise in Document Management Systems (Veeva Vault preferred) and/or other repositories. • Expertise in Office-related software (Microsoft Excel, Microsoft Word, Adobe Acrobat, etc.). • Knowledge and understanding of EPA, FDA GxP, FDA CFR 21 Part 11, OECD GLP, USDA, and VICH regulations and guidelines. • This position requires excellent organizational skills, the ability to work independently and as part of a team with strong attention to detail and accuracy. • Must learn quickly, have strong communication, organization, and writing skills with the ability to multi-task. • Ability to apply strategic and analytical thinking to a Project. • Demonstrated ability to focus and drive consistency in a fast-paced environment. • Pre-Clinical, Clinical, CMC, Regulatory or QA experience. • Veeva Vault a plus. •
Alexx is an Animal Health Global GxP Document Management System used to store Regulatory-relevant documents across R&D. This system is run within the Veeva Vault Platform (a cloud-based software). Alexx Migration Project: • Migrate and reclassify documents both paper and electronic originals (Protocols, Reports, Raw Data, Literature Articles, Quality (Formulation and Analytics), CMC Documents, Batch Release Documents, Regulatory Documents: Detailed and Critical Summaries, Sponsor Summary Reports, etc.). • Migration of documents can include external Regulatory-related documents from SharePoint sites, network shares (i.e., shared drives), 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. Responsibilities: • Must have in-depth knowledge of: Clinical, CMC, Drug Discovery, Preclinical, Quality (Formulation and Analytics), Regulatory, and/or Statistics documents to correctly identify and classify them. • Review and identify document attributes and input corresponding metadata into Alexx. • Request Study Numbers (Route of Administration, Pharmaceutical Form, Control, Test Species, GxP status, etc.), Products: (Product Family / Project Codes), and/or CRO Names using Alexx, when necessary. • Contact personnel from the appropriate Business Unit to obtain information to correctly identify documents, as needed. • 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. • This will satisfy the requirements according to EPA, FDA GxP, OECD GLP, USDA, and VICH regulations and guidelines to ensure document integrity.
Job Type: Contract
Pay: $45.00 - $50.00 per hour
Ability to commute/relocate:
- Madison, NJ 07940: Reliably commute or planning to relocate before starting work (Required)
- Documentation: 6 years (Preferred)
Work Location: One location