ACS group has an immediate need for a 'Compliance Business Analyst' with experience in the Pharmaceutical Industry. This is a 6 - month contract opportunity and is located in Lawrenceville, NJ. Our client is a leading pharmaceutical company.
Please review the job description below:
- data quality programs
- process mapping/redesign
- pharmaceutical R&D
- pharmaceutical regulatory processes
Position: Data Stewardship and Compliance Business Analyst
Work Location: Lawrenceville, NJ 08648
Duration:6 Months Contract
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 XXX's 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 XXX's 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 XXX's 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 XXX's and vendor team members to ensure that XXX's 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.
Degree Requirements 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.
Key Competency Requirements
- 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
Travel Required N/A
Describe Exposure to Any Hazards/Disagreeable Conditions in the Work Environment N/A
Thanks and regards,
P: (+1) 303-481-5170
ABOUT ACS Solutions.
ACS Solutions is a global provider of information technology solutions, talent solutions and workforce management services. Our Industry vertical based domain expertise, passion for innovation, combined with the power of technologies in cognitive sciences, cloud computing, data sciences, product engineering, robotic process automation, machine learning, and block chain, helps clients envision, build and run their businesses more efficiently. Headquartered in the US, ACS Solutions has grown to over $1.2 BN.
ACS Solutions is a Certified MBE by the Georgia National Minority Supplier Development Council.
ACS solutions has multiple subsidiaries, each focused on the unique area of business:
- Analysts international Corporation (Staff Augmentation Services)
- The Ascent Services Group Inc. (Life Sciences Talent Solutions)
- HireGenics, (Payrolling, IC Compliance, & MSP Services)
- DATA Inc. (Information Technology- staffing)
Recent Awards and Recognitions:
- 6th largest IT staffing firm in the US. (Staffing Industry Analysts (SIA) 2019)
- Largest Minority IT Staffing Firm in the US. (SIA 2019)
- ClearlyRated® 2020 Best of Staffing award winner for providing remarkable service quality to our clients. This is our ninth consecutive win.
IT and Industry certifications:
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- AWS Managed Services Partner
- Google Cloud Partner
- ISO 27001:2013 Certified for Data Security
- ISTQB Gold Partner
- ISMS (ISO 27001:2017)
- SOC2 Type II Compliant