Submission and Assessment Specialist, Full-Service REMS

Syneos Health; United States; Remote; USD 85,000 - 110,000; Full time

Job summary

A biopharmaceutical consulting company is seeking a Submission and Assessment Specialist responsible for managing client deliverables and project activities. This role involves building relationships, overseeing project strategy, and ensuring timely execution of assessments. Candidates should have a strong background in project management and be fluent in English. Competitive benefits and a remote work environment are offered.

Qualifications

• 5+ years of experience in project management or relevant field.
• Fluent in English, both written and spoken.
• Experience with regulatory and FDA interactions preferred.

Responsibilities

• Builds relationships with clients and internal teams.
• Leads project strategy for assessment activities.
• Supports multiple client programs simultaneously.

Skills

Client relationship management

Critical thinking

Project management

Communication

Problem-solving

Education

Bachelor's degree or higher

Tools

Microsoft Office

MS Project

SharePoint

Job description

Submission and Assessment Specialist, Full-Service REMS

Updated: October 3, 2025
Location: Remote, Remote, United States
Job ID:11451

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. Expectations include the ability to build relationships (internally and externally), identify client needs, design strategic and innovative solutions, manage client deliverables, coordinate with other internal program representatives, and deliver to clients on time, on budget and within scope. This practiced professional exhibits decision quality, action orientation, communication savvy, and resourcefulness as the primary steward of client(s) GRMR Strategy, Submission and Assessment projects.

JOB 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
• 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.
• 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

QUALIFICATION REQUIREMENTS

• Bachelor’s or higher degree (e.g. MBA, PhD, PharmD) in business or life sciences, or PMI Certified Associate in Project Management (CAPM) / Project Management Professional (PMP) or equivalent with significant experience (5+ years)
• Background in regulatory, medical writing or FDA interactions preferred
• Ability to assess client needs and deliver high-quality, effective communications
• Must be fluent in English (written and spoken) with excellent PC skills including Microsoft Office, Internet fluency and other related tools
• Excellent interpersonal, communication, presentation and influencing skills
• Familiarity with Project Management tools (e.g. MS Project, SharePoint)
• Demonstrated project management experience required
• Experience managing successful working relationships in a cross-functional, matrix environment
• Ability to multi-task, think critically and prioritize competing high focus priorities
• Skilled in directing the work of others and driving results
• Aptitude for translating ambiguity and uncertainty into actionable next steps through resourcefulness, resiliency, and adaptability
• Strong meeting facilitation skills

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against.