Senior Manager, Risk & Program Management Operations

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Updated: November 1, 2021
Location: Morrisville, NC, United States
Job ID: 135437

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You’re driven, resourceful, and above all else - remarkably smart.

You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn’t cut it – you’ve got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you’re known for your good nature. You’ll fit right in at Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.


You’ll join The Risk And Program Management Group within Syneos Health Consulting. You will assist pharma consortiums in facilitating the myriad legal, financial, and operational risks and nuances of program management. 

More specifically: 

An individual contributor within the Risk and Program Management Advisory Group and is primarily responsible for leading the implementation of assigned REMS Integrated Solution activities.  As a key member of the REMS Operations Office they will help advance the REMS mission and culture, and leverage their subject matter expertise and business relationships to identify industry trends and incorporate them into client work, thought leadership, and new service offerings.

REMS Operations Office
  • Operating chair of the cross-functional REMS Operations Office (ROO) meeting, and supports the chair implement the ROO charter
  • Maintains close relationships with REMS Program Leads and REMS Project Leads to maintain effective cross-functional operations
  • Provides timely insights to the RPM Quality and Operations Lead regarding ROO activities
  • Supports internal activities to drive broad organizational understanding regarding ROO and REMS Integrated Solution (RIS) capabilities

 REMS Integrated Solution

  • Implements the REMS Process Optimization project outcomes, maintains relevant project artifacts
  • Evaluate REMS Programs performance, and provide recommendations to drive REMS operational excellence
  • Support the implementation of the RIS quality program
  • Provide recommendations to expand RIS service features and maximize client satisfaction

 REMS Awareness

  • Maintains internal training materials that describe the RIS solution
  • Monitors all relevant legislation, regulations, guidance, and best practices affecting RIS services, and evaluate impact to RIS operations
  • Maintains a broad awareness of relevant Health IT topics, and participates in external REMS communities, industry groups etc.


  • Represents the RIS business team on the development of relevant company policies, procedures, and process improvement initiatives
  • Maintains highly effective working relationships with internal stakeholders
  • Supports the development and growth of the RIS
  • Exhibits professional, positive, and respectful interactions internally & externally, and displays passion and drive while advocating for superior client experiences
  • Advances the REMS quality culture through words, attitude, and actions
  • Proactively seeks opportunities to expand knowledge of the biopharmaceutical industry, Consulting service offerings, and client products and markets
  • Other duties as assigned

Job Requirements

Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:

  • Bachelor’s degree in a science/health care field, or equivalent with significant experience (5+ years)
  • Strong knowledge regarding post-marketing pharmacovigilance regulatory requirements
  • Significant experience on the design, implementation, and operations of multiple REMS programs is essential
  • Core understanding of EU Risk Management Programs preferred
  • Computer literacy commensurate with job requirements (Microsoft Office suite; basic Sharepoint proficiency)
  • Possesses cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds
  • Significant experience operating in a cross-functional environment
  • Ability to act independently and proactively
  • Strong organizational, presentation and interpersonal skills

As a healthcare company we have an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious belief. Submission & Approval of an Exemption does not guarantee that an exemption can be accommodated.

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.

Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Here, you’re a part of the big picture. We work hand in hand to guide pre-market development through post-market commercial strategy. Knowledge sharing across advisory groups unlocks the innovation and unique strategies our end-to-end commercialization projects require. Our collaborative mindset means every project is a chance to solve a new challenge, learn from your teammates, become better-rounded, and evolve your career.

WORK HERE MATTERS EVERYWHERE | How will you accelerate biopharmaceutical commercialization?

Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)


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