Clinical Documentation Specialist
- Category: Science/biotech
- Deadline: 24th May 20232023-05-24T00:00:00-0700
- New Jersey
Vacancy expired!
Job Title: Clinical Documentation Specialist Duration: 12+ Months Location: Rahway, NJ- Onsite 3x a week minimum Required Pay Scale: $42.52-45.). 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. Must Haves 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. About Matlen Silver Experience Matters. Let your experience be driven by our experience. For more than 40 years, Matlen Silver has delivered solutions for complex talent and technology needs to Fortune 500 companies and industry leaders. Led by hard work, honesty, and a trusted team of experts, we can say that Matlen Silver technology has created a solutions experience and legacy of success that is the difference in the way the world works. Matlen Silver is an Equal Opportunity Employer and considers all applicants for all positions without regard to race, color, religion, gender, national origin, age, sexual orientation, veteran status, the presence of a non-job-related medical condition or disability, or any other legally protected status. If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at email and/or phone at: //