*** MUST BE ABLE TO WORK ON AN EMPLOYEE BASIS ***NO C2C*** REMOTE-Onsite BLEND ***
***NOTE*** If your experience is not in this area of specialty, please refrain from sending your resume.
Our Client is expanding and currently seeks a
BUSINESS SYSTEMS ANALYST
For a 12+ month assignment with possible extensions!!
LOCATION: Lawrenceville, New Jersey
Position is currently remote, but must report to the office once the COVID restrictions are lifted in Lawrenceville, New Jersey
Leverage your BUSINESS ANALYSIS and Pharmaceutical skills
to help take your career with our Client to the "Next Level" for 2021 and beyond!
Our Client is seeking a Business Systems Analyst for a remote-on-site blend position to become part of their Global Regulatory Business team supporting daily operations.
The successful Business Systems Analyst will have at least 1 year of experience in the pharmaceutical Industry, preferably working with validated systems.
The Global Regulatory Business Capabilities group does the following:
• In collaboration with the business, sets the strategic business direction for the development and maintenance of systems owned by GRS, including responding to any needs
for regulatory data from other parts of the BMS 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 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 the compliance and processes, especially where systems are impacted.
This position will support the business lead of GRS systems, assisting them with operational activities related to system releases, but focused on the business instead of IT. Activities can include the development and management of business requirements, standardization of requirements for testing, UAT script design input, lead UAT dry runs, approve test plans and summaries, execution of production releases, maintenance of existing training artifacts and development of new training deliverables, account provisioning verification and approvals, design and maintenance of system user reports, user access review follow up, develop and maintain business process knowledge, assess user feedback from surveys, provide input into user enhancement requests, manage third party organization access to systems, execute releases related to Data Integrity, GXP, CAPAs, etc., system to user business communications.
The successful candidate will have direct experience with the tasks above, but should also possess specific regulatory business knowledge, such as general document management principles specifically as applied to regulatory document authoring, review and approval, regulatory operations activities particularly around regulatory information and regulatory submission management in order to help with understanding the business user viewpoint. Experience with Veeva Vault and/or Documentum is desired but not necessary.
• Demonstrates strategic thinking skills, and has the ability to drive projects based on group objectives
• Understanding of regulatory operations.
• Knowledge and experience with computer systems in an R&D environment.
• Understanding of system validation / testing, and electronic records regulations.
• Experience in leading small projects, as well as collaborating with external customers and contractors.
• Solid understanding of desktop application software suites, especially Excel.
• Good command of the English language, and able to communicate in both written and oral forms.
- 4 year degree required.
- There is no per diem with this position
- There is no relocation budgeted for this position. If this position requires you to relocate you will be responsible for those costs.
- MUST be able to work without sponsorship or VISA transfer for this position
By partnering with Kelly® Technology, you'll have direct connections to top companies around the globe—giving you the chance to put your tech skills to work on some of today's most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. We're here to help you gain experience, keep learning, and move your career forward.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're 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 (plus, did we mention we provide a ton of benefits). 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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