Delivery and Operations Product Lead – Global Patient Safety

About the role

The Associate Director, Product Lead for Global Patient Safety is a key member of the Delivery & Operations function within the Global Development IT organization. This role is based in either Armonk, NY or Warren, NJ and requires a minimum of four days onsite per week. This role is not open to fully remote or hybrid work arrangements.

Responsibilities

• Lead implementation, operational support and improvements for Global Patient Safety technology products while guiding Product Analysts and other Delivery & Operations team members.
• Intake, assess, prioritize, and validate domain specific needs/requirements including partnership with BSPs to ensure alignment between technology roadmaps and product priorities.
• Own end-to-end automating reporting solution, including driving quality and compliance by standardizing report templates, ensuring validated linkages to source data, and automating submission-readiness checks.
• Harmonize narratives, data structures, and formatting rules to improve report consistency across markets, minimizing regional variability and instilling scientific and regulatory compliance in every output.
• Build relationships with key leaders, partners, and stakeholders to clarify and negotiate (when needed) on demands and solutions.
• Identify resourcing needs and oversee internal and vendor delivery, managing service vendor associates.
• Lead steering committee meetings, working groups, system change requests, issue management, and release management for upgrades to existing product.
• Partner with Enterprise IT to help customize service offerings to meet Global Development needs where necessary.
• Track quantifiable value delivered versus plan and prepare consolidated operational reports summarizing savings.
• Serve as oversight, quality assurance and escalation point for products within team scope.

Requirements

• Bachelor's degree in a related field.
• At least 10+ years of relevant experience, including product owner experience of Global Patient Safety technology solutions (e.g., Argus).
• Experience working on end-to-end GxP implementations from requirements gathering to IQ and PQ execution.
• Knowledge of the Information Technology Service Management Framework and ITIL v3x.
• Knowledge of Software Development Life Cycle, and agile methodologies and tools (e.g., Jira, Confluence).
• Strong record of accomplishment in technology project management, stakeholder management, budget management, and collaboration skills.
• Experience motivating and building skills within a team of direct reports, instilling a process improvement culture in junior level colleagues.
• Experience participating in an end-to-end product launch or shut down across multiple teams.
• Experience hiring, supervising, managing, and mentoring a team in service of complex issues.
• Excellent communication skills and the ability to indirectly influence key partners and stakeholders with clear, concise, and well-formed messages tailored to the audience.
• Knowledge of pharmaceutical Global Development (e.g., Global Patient Safety, Regulatory Affairs, Clinical Quality) business capabilities, processes, systems, and key trends in the industry.

Qualifications

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Skills

• Project management
• Stakeholder management
• Collaboration
• Communication
• Technology project management
• Product management
• Agile methodologies
• Software development lifecycle
• ITIL v3x
• GxP implementations
• Reporting automation
• Quality assurance
• System customization
• Team leadership
• Product launch/shutdown coordination
• Product customization

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit here.

Pay

$157,200.00 - $256,600.00 annually

Schedule

Full-time, with a minimum of four days onsite per week required.