Data Stewardship and Compliance Business Analyst

Business Analyst, Architect, SDLC, Business Requirements, Analysis, Engineering, Quality, Consulting
Full Time

Job Description

Our client, a leading pharmaceutical company is hiring a Data Stewardship and Compliance Business Analyst on a contract basis.
Work Location:

Princeton, NJ
Summary

Sets the strategic business direction for the development and maintenance of systems, including responding to any needs for regulatory data

Oversees strategic direction of the data quality programs necessary to achieve and maintain high data quality

Oversees and leads the development, data readiness, process development and country onboarding of 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

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

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
Required skills:

Provide input toward validating and testing, and updating project documentation

Validate that the solution design meets business and functional requirements

Review test plans and testing results while maintaining traceability of end user requirements

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

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


The post Data Stewardship and Compliance Business Analyst appeared first on TSR Consulting Services.
Dice Id : tsrny
Position Id : 64021
Originally Posted : 1 month ago
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