Senior Manager, Full-Service REMS Strategy

7 days ago

Brockton, Massachusetts, United States Syneos Health Careers Full time
Job Summary

A Senior Manager in Strategy is an experienced project leader in the Global Risk Management and Full-Service REMS (GRMR) Business focused on Strategy, Submissions and Assessments.

Key Responsibilities
  • Productivity
    • Builds positive working relationships with clients, staff, managers, leadership, and internal support teams.
    • Achieves billable utilization and managed book of business targets in service to client engagements.
    • Proactively seeks opportunities to build skills, experiences, and relationships by contributing to program engagements and internal initiatives.
    • Manages heavy workloads and competing responsibilities.
  • Delivery
    • Responsible for creation, maintenance and evolution of customer strategy, submission and assessment activities/workstream.
    • Lead projects with cross functional involvement and supervise all functional areas that participate in strategy, submission and assessment activities.
    • Ability to support multiple programs/projects simultaneously.
    • Ability to understand and manage complex REMS program ETASU deliverables.
    • Works with project teams on responses to FDA information requests.
    • Provide subject matter expertise to project teams as they conduct activities.
    • Maintain, prioritize and execute schedule of contracted submission and assessment projects.
    • Collaborates with core team and oversight roles to design, manage, and execute all aspects of a client engagement according to the customers business goals and expectations.
    • Coordinates with additional support teams as needed through program lifecycle.
    • Optimizes work processes to maintain program scope, budget, timelines, and resource allocations.
    • Accountable for project activities and leverages internal tools and tracking systems to ensure program objectives, milestones, and timelines are met.
    • Attends client meetings and supports presentations as applicable.
    • Focal point for resolving project team member questions around strategy, submission and assessment activities.
    • Serves as the liaison with customer(s) for strategy, submission and assessment related questions and escalations.
    • Proactively escalates problems as they emerge to project leaders.
    • Ensure project is conducted according to Syneos Health and customer SOPs, as applicable.
    • Maintain project documentation to be "audit ready".
    • Participate in sponsor/regulatory audits as required.
    • Leverages critical thinking and problem-solving skills to recommend creative ideas based on data analysis, personal experience, team guidance and industry best practices.
    • Works with program management/leadership to challenge and pressure test client recommendations, when appropriate.
    • Anticipates and supports client needs, concerns, and challenges through the design of alternatives and contingency plans.
    • Demonstrates resourcefulness.
    • Navigates and resolves project ambiguity, client changes, delays/expedites, and/or unexpected findings with maturity and professionalism.
    • Maintains regular communication with program leadership.
    • Communicate with clients, team members, and program leadership on a regular basis.
    • Proactively communicates when timing is at risk.
    • "Manages up" to keep program leadership informed of activities, team dynamics, project status, scope changes, potential risks, and business development opportunities.
    • Exhibits professional, positive, respectful, and mature interactions internally & externally.
  • Community
    • Actively participates in company-sponsored events, training and professional development opportunities, meetings, and office and Advisory Group initiatives.
    • Drives a positive, collaborative, and professional team culture through words, attitude, and actions.
    • Understands personal strengths and development needs.
    • Seeks feedback and coaching.
    • Sets annual professional development goals and engages in appropriate developmental stretch opportunities.
    • Proactively seeks opportunities to expand knowledge of the biopharmaceutical industry, Consulting service offerings, and client products and markets.
    • Deepens expertise in REMS requirements, service offerings, and/or functional areas.
    • Demonstrates Syneos Health core values in action and word.

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