Syneos Health Commercial Solutions
Global Risk Management, Strategy & Operations Lead
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Description
The GRM Strategy & Operations Lead is responsible for building, leading, and scaling the Global Risk Management portion of the GRMR business. This role has accountability for global, non-US Risk Management Plan strategy and authorship, additional risk minimization measure strategy and implementation, effectiveness evaluation, country-level execution, operational governance, business development support, client relationship management, and delivery excellence.
This leader serves as Syneos Health’s primary business and subject matter lead for Global Risk Management capabilities outside the United States, initially focused on the EU and expanding to broader non-US markets. The role oversees strategy and operations resources, including direct reports and matrixed project teams, and partners with clients and internal stakeholders to translate regulatory, safety, medical, and operational requirements into practical, compliant, scalable, and inspection-ready solutions.
The role operates as a senior leader within GRMR, contributing to business direction, service offering development, client engagement, talent development, thought leadership, and continued growth of Syneos Health’s global risk management capabilities.
Responsibilities
Global Risk Management Strategy and Delivery
- Lead GRM strategy and delivery across non-US markets, initially focused on the EU and expanding to broader global markets outside the United States.
- Oversee RMP strategy, structure, authorship, review, implementation, and lifecycle management, serving as principal author, senior reviewer, or strategic advisor as needed.
- Develop strategy for aRMMs, including educational materials, HCP and patient guides, patient cards, checklists, controlled access elements, pregnancy prevention program components, DHPCs, and other locally required tools.
- Advise clients on global and regional HA expectations related to RMPs, aRMMs, implementation, effectiveness evaluation, and postauthorization commitments.
- Support HA response strategy related to RMP content, aRMM scope, local implementation, effectiveness findings, and GRM commitments.
- Partner with Safety, PV, Regulatory, Medical Affairs, Epidemiology, Quality, Technology, vendors, and local country stakeholders to ensure strategies are scientifically sound, operationally feasible, and compliant.
Country Implementation and Effectiveness
- Translate approved risk management strategies into executable global and country-level implementation plans.
- Oversee rollout planning, localization, translation, local review, HA submission or notification tracking, approval status, distribution, training, implementation evidence, and lifecycle maintenance.
- Establish and maintain country trackers, dashboards, timelines, responsibility matrices, issue/risk logs, escalation pathways, and leadership reporting.
- Lead planning and oversight of aRMM effectiveness evaluation activities, including process metrics, outcome measures, KAB surveys, utilization measures, distribution metrics, training metrics, and other fit-for-purpose approaches.
- Oversee collection, interpretation, and reporting of implementation and effectiveness data to support assessment reports, HA responses, and program improvement recommendations.
- Ensure local implementation evidence and program files are complete, current, audit-ready, and inspection-ready.
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Business Development and Client Leadership
- Own and manage the GRM portion of the GRMR business, including service offering development, book of business oversight, financial performance, delivery quality, and client satisfaction.
- Support capabilities presentations, client outreach, RFIs/RFPs, proposals, pricing assumptions, contracting support, bid defenses, and account growth.
- Serve as a senior client relationship owner and trusted advisor for assigned GRM accounts and opportunities.
- Develop and refine proposal language, pricing models, scope assumptions, delivery models, and client solution designs.
- Identify opportunities to expand client relationships through GRM strategy, authorship, implementation, effectiveness evaluation, operational support, and lifecycle management services.
Governance, Quality, and Capability Development
- Establish governance structures for GRM programs, including decision-making forums, action tracking, issue/risk management, escalation, and leadership reporting.
- Partner with Quality and Compliance to ensure GRM activities are supported by appropriate SOPs, work instructions, templates, tools, training, and controlled documentation.
- Support sponsor audits, regulatory inspections, inspection preparation, CAPAs, quality events, and inspection response activities related to RMPs, aRMMs, and GRM commitments.
- Maintain oversight of vendor performance, deliverables, timelines, documentation quality, and compliance expectations.
- Develop and improve GRM templates, playbooks, trackers, dashboards, training materials, proposal content, pricing assumptions, and standard delivery approaches.
People Leadership and Thought Leadership
- Build, lead, and evolve a high-performing GRM team inclusive of strategy and operations resources.
- Manage direct reports and matrixed team members responsible for strategy, authorship, implementation, effectiveness evaluation, and operational delivery.
- Provide coaching, mentoring, performance feedback, resource planning, workload management, onboarding, training, and succession planning.
- Represent Syneos Health as a senior GRM subject matter expert in client, industry, and internal settings.
- Contribute to thought leadership, including white papers, case studies, conference presentations, webinars, client education, and internal training.
Education Requirements
- Minimum - Bachelor’s degree or equivalent experience in Science, healthcare, pharmacy, public health, epidemiology, regulatory, or related field
- Preferred - Advanced degree (PharmD, PhD, MPH, MS, or related advanced degree)
Additional Qualifications (if Applicable)
- 12+ years of experience in pharmacovigilance, risk management, regulatory affairs, medical affairs, epidemiology, safety operations, consulting, or related life sciences functions; 15+ years preferred for Executive Director level.
- Significant experience leading global or regional RMP strategy, authorship, implementation, lifecycle management, aRMM development, and effectiveness evaluation.
- Deep working knowledge of EU risk management requirements and guidance, including RMPs, aRMMs, and effectiveness evaluation expectations; experience extending risk management approaches to broader non-US markets preferred.
- Demonstrated experience leading complex, multi-country programs involving global, regional, local affiliate, vendor, and sponsor stakeholders.
- Experience managing people, including direct reports, matrixed teams, and/or functional capability teams.
- Experience supporting client relationships, business development, proposals, pricing assumptions, bid defenses, contracting, and service offering growth.
- Experience supporting audits, inspections, CAPAs, controlled documents, quality events, or GxP quality systems.
- Strong business acumen and ability to balance quality, compliance, client needs, delivery feasibility, profitability, and growth.
- Excellent scientific writing, strategic thinking, communication, facilitation, problem-solving, and stakeholder management skills.
- REMS experience or exposure preferred as transferable experience, but not required; additional language skills preferred.
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Critical Skills
- Global Risk Management / RMP Strategy
- Additional Risk Minimization Measures
- Scientific and Regulatory Writing
- Effectiveness Evaluation and Metrics
- Global / Country-Level Implementation Oversight
- Pharmacovigilance and Benefit-Risk Management
- Regulatory Strategy and Health Authority Response Support
- GxP Quality, Compliance, Audit, and Inspection Readiness
- Business Development, Pricing, Proposals, and Bid Defense
- Client Relationship Management and Consultative Leadership
- People Leadership and Matrix Team Management
- Operational Governance, Process Improvement, and Scalable Delivery
At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.
Why Syneos Health?
We partner with industry experts to solve and execute against today's toughest commercialization challenges facing the world's leading healthcare companies. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities on our Commercial Operations and Leadership teams. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients' lives around the world.
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Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)
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