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Documentation Specialist With Pharmaceutical

Madison, NJ

Posted: 01/23/2023 Job Number: 22920083

Job Description

Hybrid (3 days Onsite - Tuesdays and Wednesdays are mandatory days, 3rd day can be Monday or Thursday).

Project Description:
  • 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).
  • 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.
  • 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.

Required Skills:
  • High School Diploma with 10 years' experience in a related field and/or industry.
  • 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.

This 12+month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com


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Bridget Burns

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