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12 Apr 2021

Temporary Business Analyst, Global Regulatory (21-09825)

iris.chen@axelon.com – Posted by iris.chen@axelon.com Lawrence Township, New Jersey, United States

Job Description

“This role is currently work-from-home and will move to the office environment after the COVID-19 restrictions are lifted.”

Business Analyst, Global Regulatory Business Capabilities

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 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 Client’ 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 Client compliance and processes, especially where systems are impacted

Position 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 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.

How to Apply

Please send your updated resume to iris.chen@axelon.com

Job Types: Temporary.

Job expires in 13 days.

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