DOCUMENTATION SPECIALIST WITH PHARMACEUTICAL MADISON, NJ Hybrid (3 days Onsite - Tuesdays and Wednesdays are mandatory days, 3rd day can be Monday or Thursday).
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.
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
ALPHA'S REQUIREMENT #23-00177
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE