-
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 USAContract
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.
- 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.
- 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.
Vacancy expired!
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