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3 Feb 2021

Temporary Regulatory Data Stewardship and Compliance Analyst (21-02291)

Axelon Services Corporation – Posted by 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.”

Job Description: Global Regulatory Business Capabilities
• In collaboration with the business, sets the strategic business direction for the development and maintenance of systems used in 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 guidances with impact to Client compliance and processes, especially where systems are impacted
The role of Business Analyst is to liaise among business stakeholders in order to elicit, analyze, communicate, and validate requirements for changes to business processes and information systems. The role is responsible for understanding and documenting specific business processes as part of Regulatory projects/programs including, but not limited to, the task of translating business requirements into functional and non-functional specifications for configurations/implementation using a commercially available (COTS) product.

This role also collaborates with other project Client and vendor team members to ensure that Client requirements are tailored for selected vendor COTS product(s).

• Understand, identify, assess, and document business requirements related to different functional areas
• Works with business stakeholders to assist in business process mapping/redesign (as needed) for realization of business benefits.
• Develop business requirements
• Translate business requirements into functional and non-functional specifications tailored for selected COTS product(s)
• Compile all elicitation results and analyze requirements
• Models business information and processes.
• Provide input into solution design, architecture, testing, and data architecture activities of the project to ensure that solution meets the requirements.
• Support the Data Architect in understanding and assessing the harmonized data requirements
• Create and update appropriate documentation following SDLC standards and templates
• Possible additional responsibilities:
o Provide input toward validating and testing, and updating project documentation.
o Validate that the solution design meets business and functional requirements. Review test plans and testing results while maintaining traceability of end user requirements.
o Assist end-users in preparation and execution of User Acceptance testing.

• Minimum 10 years’ experience in pharmaceutical R&D
• Experience working across Pharmaceutical R&D specifically regulatory information management (RIM)
• Understanding of information flow, submission process and content management approaches supporting pharmaceutical R&D.
• Demonstrated ability in liaising with stakeholders to elicit, analyze, communicate, and validate requirements for changes to business processes and information systems.
• Knowledge of pharmaceutical regulatory processes, such as end-to-end drug development process and knowledge of those functions.
• Knowledge of biopharmaceutical product development is a plus.
• Relevant information systems experience in a GxP environment.
• Domain Knowledge: Understands the Life Sciences regulatory processes and how technology solutions can improve or enhance existing processes and overall business results.
• Business Requirements Analysis/Documentation: Defining, documenting, and communicating business requirements.
• Requirements Testability and Traceability: Verifying that requirements used in test cases match those requirements used in the development process.
• Process Design / Re-Engineering: Analyzing design of business workflows, recommending changes to business processes under the framework of the ERBM mission, goals and critical business measures such as cost, quality, service and speed
• Quality Assurance Standards and Governance: Developing and establishing risk-based systems development life cycle documentation, policies, and procedures to support implementation and delivery of non-regulated and regulated solutions and systems

How to Apply

Please send your updated resume to

Job Types: Temporary.

Job expires in 58 days.

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