Associate Submission and Assessment Specialist, Full-Service REMS

Description

The Manager supports execution of strategy, submissions, and assessments within the Global Risk Management and Full-Service REMS (GRMR) business, contributing across both U.S. REMS and global Risk Management Plans (RMPs). This role coordinates day-to-day project activities, drafts deliverables, tracks milestones/budgets, and drives high-quality, audit-ready documentation in partnership with senior team members.

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
• Drafts and maintains submission packages (REMS, REMS Modifications/Assessments; RMPs and variations) and responses to information requests under SME guidance.
• Tracks requirements across regions (FDA/EMA/HC/other NRAs), aligning REMS deliverables with global risk minimization materials and evaluation plans.
• 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
• Maintains trackers, dashboards, and document repositories to ensure inspection readiness and version control.
• Prepares meeting materials and contributes to client presentations and health authority rehearsal sessions.
• Exhibits professional, positive, respectful, and mature interactions internally & externally
• Other duties as assigned

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.
• Demonstrates Syneos Health core values in action and word

QUALIFICATION REQUIREMENTS

• Bachelor's degree in life sciences, pharmacy, public health, or related field; advanced degree or certification (e.g., CAPM/PMP) a plus.
• Hands-on experience supporting REMS and/or Risk Management Plans (EU/ROW) or adjacent regulatory/safety deliverables.
• Strong organization, attention to detail, and documentation control skills; comfort with templates and SOPs.
• Proficient in Microsoft Office and collaboration platforms; experience with MS Project and SharePoint preferred.
• Strong meeting facilitation skills
• Excellent time-management skills

The annual base salary for this position ranges from $110,490 to $149,486. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. In addition, some positions may include eligibility to earn commissions/bonus based on company and / or individual performance.

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.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position will include a competitive compensation package, Health benefits to include Medical, Dental and Vision, Company match 401k, flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos Health complies with all applicable federal, state, and municipal paid sick time requirements.