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  2. New Jersey
  3. Lawrenceville
  4. Science/biotech
  5. Regulatory and Medical Affairs Associate
  • ID
    #17795040
  • Job type
    Contract
  • Salary
    BASED ON EXPERIENCE
  • Source
    Alpha Consulting Corp.
  • Date
    2021-08-03
  • Deadline
    2021-10-02

Regulatory and Medical Affairs Associate

 New Jersey, Lawrenceville, 08648 Lawrenceville USA
 
Contract

Vacancy expired!

REGULATORY AND MEDICAL AFFAIRS ASSOCIATELAWRENCEVILLE, NJRequired Skills:

  • The successful candidate will hold a minimum of a BS/BA in a relevant scientific or technical field and will have 1-3-year experience in the pharmaceutical Industry, preferably working with validated systems.
Desired Skills:
  • Demonstrates strategic thinking skills and could drive projects based on group objectives.
  • Understanding of regulatory operations.
  • Knowledge and experience with computer systems in an R&D environment.
  • Understanding of system validation / testing, and electronic records regulations.
  • Experience in leading small projects, as well as collaborating with external customers and contractors.
  • Solid understanding of desktop application software suites, especially Excel.
  • Good command of the English language, and able to communicate in both written and oral forms.
Project Description: This position will support the business lead of GRS systems, assisting them with operational activities related to system releases, but focused on the business instead of IT. The successful candidate will possess specific regulatory business knowledge, such as general document management principles specifically as applied to regulatory document authoring, review and approval, regulatory operations activities particularly around regulatory information and regulatory submission management to help with understanding the business user viewpoint. In addition to the above, candidates should also have direct experience in the development and management of business requirements, standardization of requirements for testing, UAT script design input, lead UAT dry runs, approve test plans and summaries, execution of production releases, maintenance of existing training artifacts and development of new training deliverables, account provisioning verification and approvals, design and maintenance of system user reports, user access review follow up, develop and maintain business process knowledge, assess user feedback from surveys, provide input into user enhancement requests, manage third party organization access to systems, execute releases related to Data Integrity, GXP, CAPAs, etc., system to user business communications. Experience with Veeva Vault and/or Documentum is desired but not necessary.The Global Regulatory Business Capabilities group does the following:
  • In collaboration with the business, sets the strategic business direction for the development and maintenance of systems owned by GRS, including responding to any needs for regulatory data from other parts of the Client's enterprise.
  • Oversees strategic direction of the data quality programs necessary to achieve and maintain high data quality in GRS systems.
  • Oversees and leads the development, data readiness, process development and country onboarding of the Client's medical product data management program.
  • Establishes and maintains a set of regulatory standards for data and processes in scope.
  • Responsible for the leadership and oversight of operational activities for implemented systems and processes.
  • Evaluates internal and external requirements and guidance with impact to the Client's compliance and processes, especially where systems are impacted.
This 12+ month position starts ASAP.Please E-MAIL your resume (attachment to email) with rate and availability to Jim: ALPHA'S REQUIREMENT #21-02491W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE#ZR#LI-JP1

Vacancy expired!

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