Job Description

Data Stewardship and Compliance Business Analyst
Job Number: 21-12664
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Data Stewardship and Compliance Business Analyst for our client in Lawrenceville, NJ. 
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:
  • Division Research and Development / Global Regulatory, Safety and Biometrics / Global Submissions and Regulatory Policy - Global Regulatory Business Capabilities
  • Functional Area 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 guidance’s with impact to Client compliance and processes, especially where systems are impacted
  • Position Summary / Objective 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).
 
Responsibilities:
  • 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
  • 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.
 
Qualifications:
  • 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.
 
Required Skills:
  • 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
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
June Binuya
junethel.binuya@eclaro.com
2128047476
June Binuya | LinkedIn
 
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
 

Application Instructions

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