Description

The Strategy Lead is an experienced project leader and principal author within Syneos Health’s Global Risk Management & REMS (GRMR) business. You will define the strategy and authoring approach for EU Risk Management Plans (RMPs) and additional Risk Minimisation Measures (aRMMs), guide effectiveness evaluation planning, and partner cross‑functionally to ensure compliant, scalable implementation across countries. You will build relationships with sponsors and internal teams, translate regulatory requirements into practical plans, oversee deliverables, and keep programs on time, on budget, and in scope—consistent with Syneos GRMR role expectations and format.

What You’ll Do (Job Responsibilities)

Strategy & Authorship

• Lead end‑to‑end RMP strategy and authorship (Core & Local), including risk characterization, safety specifications, PV activities, and aRMM design (education materials, DHPCs, checklists, PPCs, KAB surveys) aligned to GVP Module V/XVI and Addendum II.
• Own aRMM effectiveness frameworks (outcomes/KAB, process metrics), define evaluation designs, and align with sponsor and local affiliate needs.
• Serve as principal writer/reviewer for core RMP sections and country adaptations; coordinate translations and localization plans with affiliates and vendors.

Cross‑Functional Delivery & Governance

• Partner with Operations/Account Management to orchestrate multi‑country rollout scenarios and ensure readiness of training, distribution, and documentation.
• Collaborate with Technology on specifications for digital aRMM enablement (GRM Central), reporting needs, and integrations (e.g., Veeva/Orbit) to enable tracking of commitments and implementation metrics.
• Align with Quality & Compliance on controlled document suites (SOPs/WIs/templates) and inspection‑readiness for GRM programs (audit‑ready files, deviation/CAPA pathways).

Submissions & Health‑Authority Interactions

• Define submission strategy/timelines (central and national), support responses to HA information requests, and facilitate negotiations on aRMM scope/implementation.

Outcome Reporting & Continuous Improvement

• Specify metrics/monitoring plans; lead synthesis of outcomes into effectiveness/assessment reports and change recommendations.
• Feed learnings into templates, playbooks, and controlled documents to scale future programs.

Client Leadership & Financials

• Act as primary strategy point of contact for assigned programs; facilitate client workshops; maintain scope, budget, and timelines; and contribute to account growth.

Minimum Qualifications

• Advanced degree in life sciences or public health (PharmD/PhD/MPH) or equivalent experience.
• Experienced in EU risk management/pharmacovigilance with hands‑on RMP authorship and aRMM design across multiple EU markets.
• Deep working knowledge of EMA/GVP guidance: Module V (Risk management systems), Module XVI (Risk minimisation measures), and Addendum II (effectiveness).
• Proven ability to lead matrixed teams and manage complex, multi‑country deliverables.
• Excellent scientific writing, editorial rigor, and stakeholder facilitation.

Preferred Qualifications

• Experience with effectiveness evaluation (e.g., KAB survey design, process/outcome KPIs).
• Familiarity with RMP/aRMM tracking and content systems (e.g., Veeva SafetyDocs, Orbit RMP Tracker) and regulatory intelligence tools (e.g., Clarivate Cortellis, Insuvia/iViReg).
• REMS/ETASU exposure (translatable to EU RMC).
• Additional EU language(s) a plus.

Key Success Measures (first 6–12 months)

• Delivery of ≥ 2 core RMPs and country adaptations meeting agreed timelines/quality bars.
• Implementation of a standard aRMM effectiveness toolkit (templates, metrics, reporting) across at least one multi‑country program.
• Contribution to controlled document readiness (SOPs/WIs/templates) for GRM prior to launch windows.

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? Here, you’re a part of the big picture. You will collaborate with colleagues across clinical and commercial disciplines to guide premarket development through post-market commercial strategy. Every project is a chance to solve a new challenge, learn from your colleagues, and advance your career. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities. 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)

Syneos Health has a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements.