Regeneron

Director

• Drive the development, coordination, and implementation of all Patient Support Services (PSS) initiatives for myRARE, ensuring alignment to the brand team’s key objectives
• Lead, inspire, and structure the team around you to deliver consistently for our patients, providers, and other key stakeholders
• Achieve performance goals by owning all aspects of your business, including being the subject matter expert on your service mix, market access landscape, patient and prescriber trends, and integration with field teams
• Create and manage the myRARE budget across multiple brand budgets, drive operational and financial efficiencies, and hold internal team and suppliers accountable for delivering consistent operations within allotted funding
• Advance the product portfolio by optimizing program offerings and continually assessing the program’s overall performance in the marketplace
• Analyze and effectively present program insights to senior leaders across the Commercial department
• Compile business plans to develop and implement innovative service offerings that continually enhance the customer experience to accessing and maintaining therapy
• Drive the development and management all myRARE correspondences and content through review committee
• Partner with other market access roles to develop materials and messaging that highlight the impact of our support
• Collaborate with PSS peers and external suppliers to extend best practices across programs, optimize strategic relationships, and take on big ideas that challenge the status quo
• Cultivate talent and capability of employees inside and outside of PSS
• Act with integrity and urgency while complying with all Regeneron operating principles

Director, Patient Support Services – Rare Disease

Product Manager

• guide the vision, roadmap, and delivery of sales technology solutions
• partner with commercial teams to align technology with business priorities
• shape product roadmaps for CRM and related sales platforms
• translate business needs into functional designs, testing, and deployment plans
• guide solutions across Veeva Vault CRM and Salesforce Life Sciences Cloud
• build cases, estimates, and benefit analysis for key initiatives
• identify process gaps and recommend improvements for efficiency and compliance
• support training and communications to strengthen adoption and end-user effectiveness
• explore AI capabilities to enhance commercial technology and actionable insights

Senior Manager, Product Management – Commercial IT

• guide the vision, roadmap, and delivery of sales technology solutions
• work closely with commercial and IT partners
• shape product roadmaps for CRM and related sales platforms
• translate business needs into functional designs, testing, and deployment plans
• build cases, estimates, and benefit analysis for key initiatives
• identify process gaps and recommend improvements for efficiency and compliance
• support training and communications to strengthen adoption and end-user effectiveness
• explore AI capabilities to enhance commercial technology and actionable insights

Senior Manager, Product Management

Program Manager

• Provide operational leadership, direction and support of a program throughout its lifecycle
• Independently lead multiple or complex development programs
• Partner with the Strategic Program Lead to provide operational leadership
• Independently assess and proactively address program needs from pre-IND through commercialization
• Strengthen and lead high performance teams
• Drive team alignment in creation of integrated project/program plans, timelines and budgets
• Direct annual program goal setting and monitor progress against these goals
• Champion potential program risks and ensure contingency plans are in place
• Prepare and manage the process for major presentations affecting business decisions
• Ensure effective, accurate, and timely scientific/technical communication

Director, Drug Development Program Management

Risk

• Own and maintain service governance, including decision rights ensuring clear purpose and defined business rules.
• Lead SLA/OLA design and strategy, ensuring alignment with business expectations, risk controls, and operational capacity.
• Maintain governance standards including catalog/routing/task design, risk controls, and the enterprise escalation matrix.
• Establish and enforce frameworks that support scalable, predictable, and high‑quality service performance.
• Partner with HR Tech and external vendors to ensure tools, workflows, and platforms enable governance and future scalability.
• Lead the enterprise VOC and KPI governance framework, including dashboard standards and performance measurement.
• Translate insights into service improvements that strengthen the HR4U service model.
• Own the SLA/KPI reporting strategy, ensuring clear, accurate, and actionable performance storytelling.
• Conduct root‑cause analysis and govern performance remediation plans to address systemic issues.
• Oversee operational controls, compliance, and Tier 2 quality frameworks, including QA programs, scorecards, and training.
• Lead the change and readiness strategy for HR4U service lifecycle enhancements.
• Ensure enterprise-wide adoption of new standards, capabilities, and governance updates across HR and COEs.
• Govern training and readiness programs, including Tier 2 COE training and role‑based enablement.
• Manage the rollout and decommissioning of processes to maintain operational consistency and service integrity.
• Oversee alignment to service standards, quality expectations, and compliance requirements across the HR ecosystem.

HR Service Governance Leader

Operations

• Support GMI and Operations Director by streamlining processes and enhancing strategic execution
• Ensure the contact center is equipped with resources, training, and guidance support
• Coordinate global operational activities and support process improvements
• Collaborate with GMI and partners to implement new MI platforms and technologies
• Maintain inspection-ready operational records
• Lead development of advanced analytics dashboards and reporting templates
• Monitor and analyze MICC medical inquiry volume, trends, response quality, and performance metrics
• Support fulfillment of unsolicited medical information requests

Associate Director, Global Medical Information Operations

• Lead efforts of the Biostatistics department with cross-functional teams to articulate drug development questions
• Assess the feasibility of endpoints and frame statistical approaches to address those questions
• Design clinical experiments and interventional studies to generate and analyze the resulting data
• Work with teams to appropriately interpret the results and make decisions
• Represent statistical issues in regulatory agency meetings
• Lead the development and delivery of training to non-statistical colleagues
• Lead the development of new infrastructure and processes
• Represent the company in professional associations, conferences, and publications
• Mentor and oversee less experienced statisticians, with the potential to manage full-time staff

Associate Director, Biostatistics – Genetic Medicine

• The Director, Field Reimbursement is a strategic and operational leader responsible for building, leading, and optimizing a team of Field Reimbursement Managers (FRMs)
• Support the launch and growth of a rare disease therapy
• Drive patient access across a complex reimbursement landscape
• Serve as a critical cross-functional partner to Market Access, Patient Services, Sales, Medical Affairs, and Trade
• Establish clear performance expectations aligned to launch objectives and patient access goals
• Provide ongoing field coaching, including joint field engagements and strategic account planning
• Translate brand and market access strategy into actionable field reimbursement tactics
• Support successful launch of a provider-administered subcutaneous therapy in a competitive market
• Monitor payer trends, policy changes and channel shifts impacting access

Regional Director – Field Reimbursement, Neuro

• Lead efforts of the Biostatistics department with cross-functional teams
• Represent statistical issues in regulatory agency meetings
• Design clinical experiments and interventional studies
• Lead development and delivery of training to non-statistical colleagues
• Mentor and oversee less experienced statisticians

Associate Director, Biostatistics – Thrombosis

• lead scientific communication and medical information strategy for assigned therapeutic areas
• manage the tactical execution of Global and US Medical Affairs medical information plans
• develop and deliver high-quality, balanced, and scientifically accurate responses to medical inquiries
• lead the creation and maintenance of deliverables, including literature reviews, Standard Response Documents (SRDs), verbal FAQs, Q&As, AMCP dossiers, and compendium
• medical reviewer on Promotional and Medical Review Committees, ensuring medical accuracy, clarity, and compliance
• own department reporting processes and dashboards
• evaluate, pilot, and implement AI-enabled tools and technologies to streamline medical information processes
• collaborate with global and regional Medical Affairs partners
• provide scientific support for congress planning and booth activities
• mentor and train new hires and less experienced colleagues

Associate Director, Medical Information

Compliance

• Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development
• Assist in coordination and preparation for Agency meetings and associated briefing document preparation
• Leads and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries
• Provide periodic status updates regarding conditions/commitments
• Provide representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings

Manager, Regulatory Affairs Strategy – Immunology, Inflammation

Medical writer

• Works with team members and with MW lead oversight to create the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas
• The MW may serve as lead for a compound and is expected to manage and facilitate completion of documents
• Ensures adherence to internal standards and procedures
• Maintains document standardization via model documents/templates and appropriate peer review
• Remains current with writing guidelines and industry standards, participates in educational opportunities, reads professional publications

Medical Writer

Manager

• Support the analysis of PRO data ensuring methodological rigor, and regulatory adherence.
• Create and refine statistical analysis plans, conduct complex statistical analyses and convey findings to internal and external stakeholders.
• Apply fit for purpose statistical methods tailored to specific study objectives, ensuring robust data interpretation and insight generation.
• Develop working knowledge of Regeneron asset(s) and support efforts to apply appropriate tools within therapeutic areas.
• Strong understanding of data sources and leverage hands on data review to guide the selection of appropriate techniques and methods.
• Authoring of technical documents including statistical analyses plans, programming specifications and TFL mock shells.
• Support statistical efforts for assigned projects, manage timelines, resources, and coordinate across departments and external stakeholders.
• Stay informed on industry trends, incorporate emerging biostatistical methods to enhance analysis and participate in methodological research for the development of analytical techniques.
• Assist preparation for biostatistical support on PRO analysis during regulatory interactions, and provide statistical efforts to address queries to ensure alignment with regulatory standards for organizational decision-making processes.
• Stay informed with guidance documents from regulators to industry on use of PROs for regulatory decision making.

Manager, Biostatistics – Patient Reported Outcomes (PRO)

• Provide support for the management of the regulatory submission form process, reviewing clinical regulatory documentation submitted to global health authorities to enable lot release for clinical trials and commercial markets.
• Lead and coordinate the pre-submission review process to ensure CMC regulatory documentation aligns with global requirements and country-specific expectations.
• Participate in cross-functional meetings to identify CMC regulatory issues related to submission documentation; ensure clear communication between IOPS and global development on submission-related risks.
• Develop and improve procedures and systems for review and feedback on the CMC global clinical regulatory submission packages, approvals, and status updates to improve visibility and efficiency.
• Lead meetings and presentations on complex regulatory issues; contribute to and build regulatory justifications to support filings.
• Provide CMC regulatory submission oversight of CRO activities, ensuring deliverables meet compliance standards and timelines.
• Keep management and collaborators advised of assessments, overall strategy, and project status through structured reporting and updates.
• Implement comprehensive training, tools, and reporting metrics for senior management to strengthen submission compliance and operational readiness.
• Act as a submission compliance liaison with Regulatory Affairs, Regulatory Submission Management, Clinical Drug Supply and Logistics, and Quality to ensure submissions appropriately support the release of investigational product.
• Support activities by ensuring documentation completeness and compliance.
• Mentor, coach, and, where applicable, manage direct reports to develop regulatory capabilities and consistent practices.

Senior Manager – Regulatory Submission Compliance

Business Operations

• drive process improvement and operational excellence
• identify process bottlenecks through data-driven techniques
• partner with SMEs in the development of process improvement plans
• engage with senior leaders to drive action
• lead Business Process Design Activities
• drive business process alignment and integration across programs and functional areas
• establish key performance metrics and reports to evaluate process effectiveness
• conduct process impact assessments and integrate processes into documentation
• define stakeholder impact and provide process guidance
• collaborate with IT for technology solutions
• organize and maintain comprehensive process documentation
• provide guidance and mentorship to junior team members