Position: Documentation Specialist - III (Senior)
Location: Rahway, NJ 07065 (Hybrid)
Duration: 12 Months
About Project:
· 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.
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. (should be reflected in the body of the resume)
· Veeva Vault a plus.
NOTES:
· Must be able to follow directions.
· Position requires extensive attention to detail - should be reflected on resume - no misspellings or formatting errors.
· Should have 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).
Job Types: Full-time, Contract
Salary: Up to $40.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Education:
Experience:
- Clinical documentation improvement: 7 years (Required)
- Document management systems: 1 year (Required)
- FDA: 1 year (Required)
- Veeva Vaut: 1 year (Preferred)
Work Location: One location
