Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Data Stewardship and Compliance Business Analyst** at a prestigious Fortune 500 company working in **Lawrenceville** **, NJ.**


**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the Submit Resume button included within.


**Job Title: Data Stewardship and Compliance Business Analyst**


**Pay: $90 per hour**


**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


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 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 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 and vendor team members to ensure that 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.

N/A

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


**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com **.**


**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**


**Kelly Services is an Equal Opportunity Employer**


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)