Job Details

ID #12195645
State New Jersey
City Lawrenceville
Job type Contract
Salary USD Negotiable Negotiable
Source TSR Consulting Services, Inc.
Showed 2021-04-13
Date 2021-04-12
Deadline 2021-06-11
Category Et cetera
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Business Analyst- Regulatory - W2 only

New Jersey, Lawrenceville, 08648 Lawrenceville USA

Vacancy expired!

TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence. Our client, a leading Pharmaceutical company is hiring a Business Analyst on a Contract basis. Please contact me directly if you are interested in learning more about this opportunity or to discuss our referral program if you know anyone that may be interested. Rate type: W2 only Job Title: Business Analyst, Global Regulatory Business CapabilitiesThe 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 Major Pharmaceutical Company enterpriseOversees strategic direction of the data quality programs necessary to achieve and maintain high data quality in GRS systemsOversees and leads the development, data readiness, process development and country onboarding of Major Pharmaceutical Company medical product data management programEstablishes and maintains a set of regulatory standards for data and processes in scopeResponsible for the leadership and oversight of operational activities for implemented systems and processesEvaluates internal and external requirements and guidance with impact to Major Pharmaceutical Company compliance and processes, especially where systems are impactedPosition 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. Activities can include 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.The successful candidate will have direct experience with the tasks above, but should also 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 in order to help with understanding the business user viewpoint. Experience with Veeva Vault and/or Documentum is desired but not necessary.Experience: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 has the ability to drive projects based on group objectivesUnderstanding of regulatory operationsKnowledge and experience with computer systems in an R&D environmentUnderstanding of system validation / testing, and electronic records regulationsExperience in leading small projects, as well as collaborating with external customers and contractorsSolid understanding of desktop application software suites, especially ExcelGood command of the English language, and able to communicate in both written and oral forms.Sincerely yours, Nitin Patel Senior Technical Recruiter TSR Consulting Services, Inc. 379 Thornall Street, 6th Floor, Edison, NJ 08837 Office: www.tsrconsulting.com

Vacancy expired!

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