System Implementation Lead & Project Manager, R&D - MedTech

Johnson & Johnson Innovative Medicine • Raritan, NJ

10d • $109,000 - $174,800 • Hybrid

About The Position

The R&D Data Science & Management team within Ethicon R&D Advanced Evaluation develops innovative laboratory solutions leveraging a variety of different data sources across testing areas. The System implementation Lead & Project Manager will lead the team(s) responsible for developing cutting-edge methodologies to drive critical global rapid regulatory approaches and development decisions by positively impacting the way Ethicon conducts data collection and analysis.

Requirements

• A bachelor’s degree in a quantitative field (e.g., engineering, artificial intelligence, computer science, statistics, biostatistics, biomedical informatics, applied mathematics, or similar) is required.
• 5+ years’ experience supporting GxP computerized systems within a regulated environment (e.g., pharma, medical device, biotech, diagnostics) is required.
• Working knowledge of 21 CFR Part 11 and data integrity principles (e.g., ALCOA+), including electronic records and electronic signatures is required.
• Experience with both Agile and waterfall style project management is required.
• Proven project leadership in complicated context, able to influence and engage the strategic and technical partners in a matrix organization is required.
• Proven track record of consistently delivering on high impact data science projects
• Demonstrated experience in leading cross-functional teams and managing external vendors is required.
• Ability to work in an agile matrix environment
• Excellent interpersonal, communication, and presentation skills
• Proficiency in Information Systems is required
• Ability to effectively communicate technical work to a wide audience

Nice To Haves

• Master’s degree preferred
• May be required to wear PPE when entering laboratories

Responsibilities

• Independently partner with the Ethicon R&D Portfolio Management and Analytical Evaluation teams to execute on the priorities, building a roadmap to deliver the data supporting projects from conceptualizing the research questions, data feasibility, study design and analysis to final presentation to senior cross-functional leaders and publication
• Be able to advise and contribute to projects outside of their responsibilities and collaborate with research scientists in diverse projects
• Deliver scalable automated solutions and insights to impact functions and testing areas within R&D and participate in cross-functional collaborations with internal scientific and data science teams, and external companies
• Lead and contribute to automated solutions and artificial intelligence solutions to accelerate and enable testing capacity
• Leverage emerging scientific and technological developments to generate new research ideas, solutions and initiatives using multiple data sources. (LIMS, ERP, others)
• Provide thought leadership for developing, adapting, and delivering data aggregation/reporting methodologies to identify trends from large data sets
• Be a hands-on technical leader among the Data Science team, helping institute best practices while crafting a data-driven culture, developing, and mentoring more junior members of the team while advocating for skill development, working alongside a robust team of data scientists, bringing fresh perspectives and scientific rigor across Data Science projects and product material areas
• Clearly articulate highly technical methods and results to diverse audiences and partners to drive decision-making
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed
• Plan and execute risk-based validation activities (e.g., validation plans, user requirements, traceability, testing, and summary reports) for GxP-relevant systems supporting laboratory and quality processes.
• Design, author, and manage test cases across SDLC phases (unit/sprint testing, integration, system, UAT, and SAT); maintain requirements-to-test traceability.
• Support test automation strategy: identify candidates for automation, author automation scripts (where applicable), and maintain automated test suites to support regression and release readiness.
• Lead/participate in deviation investigations, non-conformances and CAPA related to computerized systems, data integrity, and validation gaps.
• Assess and document Part 11 applicability and controls (e.g., electronic records/e-signatures), including data audit trails, system audit trails, system access, unique user IDs, and electronic signature meaning.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level