Submission and Assessment Specialist, Full-Service REMS

Syneos Health; United States; Remote; USD 132,000 - 180,000; Full time

Job summary

A leading biopharmaceutical organization is seeking a Submission and Assessment Specialist. The role focuses on managing client strategies related to REMS program deliverables and requires strong project management skills, including experience in medical writing. Successful candidates will exhibit excellent communication and problem-solving abilities while delivering on client expectations.

Benefits

Competitive salary

Health benefits including Medical, Dental and Vision

Company match 401k

Flexible paid time off (PTO)

Qualifications

• 5+ years of project management experience required.
• Experience in medical writing preferred.
• Fluent in English with excellent PC skills.

Responsibilities

• Build relationships with clients and internal teams.
• Lead projects with cross-functional involvement.
• Manage project timelines and client engagements.

Skills

Project Management

Medical Writing

Communication

Critical Thinking

Problem Solving

Education

Bachelor’s or higher degree in business or life sciences

PMI Certified Associate in Project Management (CAPM) or Project Management Professional (PMP)

Tools

MS Project

SharePoint

Job description

Submission and Assessment Specialist, Full-Service REMS

Updated: May 30, 2025
Location: Remote, Remote, United States
Job ID:7935

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)
• Experience in medical writing
• Experience in project management
• 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

The annual base salary for this position ranges from $132,685 to $179,515. 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.

W o r k H e r e M a t t e r s E v e r y w h e r e | How are you inspired to change lives?

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.

Discover what our more than 29,000 employees already know: work here matterseverywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday workimprovespatients’ lives around the world. Selecting us as an employer secures acareer inwhich you’re guaranteed to:

Syneos Health is a leading fully integrated biopharmaceutical solutions organization builtto accelerate customer success. We translate unique clinical, medical affairs and commercialinsights into outcomes to address modern market realities. To learn more about how we areShortening the distance from lab to life, visit syneoshealth.com .

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receiveconsideration for employment without regard to race, color, age, religion, marital status,ethnicity, national origin, sex, gender, gender identity, sexual orientation, protectedveteran status, disability or any other legally protected status and will not bediscriminated against. If you are an individual with a disability who requires reasonableaccommodation to complete any part of our application process, including the use of thiswebsite, please contact us at: Email: [emailprotected] One of our staff members willwork with you to provide alternate means to submit your application.