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Risk and Program Management Advisory Group

Building a strong foundation for product approval and commercial success

The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) so it can approve or continue to approve a prescription drug to ensure the benefits outweigh the risks. In some cases, the FDA may require brand and generic sponsors to jointly develop and implement a REMS (called a shared system REMS).

When this happens, it raises an always-complex challenge: How to enable successful collaboration among marketplace competitors in the design, development and implementation of single shared programs that cover multiple assets?

In these cases, it is crucial to have the support of an experienced Program Management Office (PMO).

Our Risk & Program Management team can be your PMO, or we can support individual service needs for many postmarketing requirements/commitments.

Project management processes and methods to help you manage complexity for all of your post-market regulatory needs

Our Risk & Program Management Advisory Group supports pharma clients through the development, implementation, and ongoing management of single and shared Risk Evaluation & Mitigation Strategies (REMS) and other post-marketing risk minimization projects (e.g., postmarketing requirements/commitments, global risk management plans). Services include:

  • Supplemental staff for clients needing associates with REMS and/or post-marketing risk minimization knowledge
  • Project management support and expertise
  • REMS and post-marketing risk minimization strategy and regulatory consulting
  • Submission and assessment support
  • Grant management system and support (e.g., continuing education, educational grants, investigator-sponsored research)
  • Type V drug master file (DMF) holder and agent
  • Knowledge, attitude, and behavior (KAB) surveys
  • Usability testing, focus groups, and market research
  • Food & Drug Administration (FDA) advisory committee meeting support
  • PMO support for multi-sponsor and/or multi-stakeholder programs (e.g., shared REMS, post-marketing requirements/commitments, global risk management plans)
  • Vendor procurement and management

The services provided in our PMO offering include but are not limited to:

Making decision-making easier and more efficient for sponsor representatives

We are committed to providing excellence in program management beyond shared REMS as well. Our dedicated and experienced team combine classical strategic consulting skills with core program management capabilities to help our customers navigate any challenges that require program/project management.

Our experience

  • Over a decade of providing PMO services
  • 100% client retention rate driven by customer satisfaction
  • Over 84 customers across 15 programs
  • Highly experienced leadership team with an average of 12 years of pharmaceutical industry experience each
  • PMO for 8 of the 17 currently approved shared REMS

How can we help you?

Leadership Team

Lindsay Crampton
Executive Managing Director, Risk & Program Management (RPM) Lead

20 years of patient safety experience focused on safety surveillance, real world evidence, data analytics, risk minimization action plans, REMS, and observational patient and pregnancy registries

John West
Managing Director, Risk & Program Management (RPM)

20+ years of experience in clinical and commercial roles in the pharmaceutical industry, currently focusing on project management and multi-sponsor and single sponsor Program Management Office (PMO) engagements.

Mary Orosco
Managing Director, Risk & Program Management (RPM), Global Risk Management &REMS Account Management Lead

Over a decade of REMS experience focusing on program management, regulatory and REMS strategy. Member of RPM team who support 15 REMS Programs for 80+ REMS Sponsors.

Nyssa Hoch
Managing Director, Risk & Program Management (RPM)

16+ years combined experience with REMS, medical writing, survey design and analysis, and people management, focusing on program, client, and vendor management operations for large multi-sponsor programs.

Adam Martin
Director, Risk and Program Management (RPM)

Over a decade of pharmaceutical management consulting experience with a focus on complex shared REMS programs, regulatory compliance, and closed pharmacy system distribution design and implementation.

Brynn Barker
Director, Risk & Program Management (RPM)

15+ years of combined experience focused on FDA-required REMS and post-marketing requirements, survey design and analysis, Grant Management System development and operations, regulatory affairs, clinical trial and nutrition-related field research, and people management.

Interested in Syneos Health?