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Risk Evaluation Mitigation Strategy Rems Jobs (NOW HIRING)

UCB

Global Quality Auditing Lead REMS/GCP

Raleigh, NC · Hybrid

... REMS (Risk Evaluation & Mitigation Strategies) and Clinical Trials programs. They are responsible for providing input to processes and areas impacted by REMS, Good Pharmacovigilance Practice (GVP ...

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Risk Evaluation Mitigation Strategy Rems information

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How much do risk evaluation mitigation strategy rems jobs pay per hour?

As of Jun 14, 2026, the average hourly pay for risk evaluation mitigation strategy rems in the United States is $30.34, according to ZipRecruiter salary data. Most workers in this role earn between $19.47 and $38.70 per hour, depending on experience, location, and employer.

What are Risk Evaluation and Mitigation Strategies (REMS)?

Risk Evaluation and Mitigation Strategies (REMS) are drug safety programs required by the U.S. Food and Drug Administration (FDA) for certain medications with serious safety concerns. The goal of REMS is to ensure that the benefits of a drug outweigh its risks by implementing specific requirements such as medication guides, healthcare provider training, patient monitoring, or restricted distribution. REMS programs are tailored to the specific risks associated with each medication and may involve collaboration among manufacturers, healthcare providers, and patients. Compliance with REMS is mandatory for continued approval and use of the drug in the United States.

How does a Risk Evaluation and Mitigation Strategy (REMS) professional typically collaborate with cross-functional teams to implement and monitor REMS programs?

REMS professionals frequently work alongside regulatory affairs, clinical, pharmacovigilance, and commercial teams to design, implement, and maintain REMS programs. Their role involves coordinating with both internal stakeholders and external partners—such as healthcare providers and pharmacies—to ensure compliance with FDA requirements. Effective communication and project management skills are essential, as REMS professionals must facilitate training, develop educational materials, and monitor the ongoing effectiveness of the program. The collaborative nature of this position offers broad exposure to various functions within the pharmaceutical or biotech company, supporting both compliance and patient safety.

What are the key skills and qualifications needed to thrive as a Risk Evaluation and Mitigation Strategy (REMS) Specialist, and why are they important?

To thrive as a REMS Specialist, you need a solid background in regulatory affairs, pharmacovigilance, and clinical compliance, often supported by a degree in pharmacy, life sciences, or a related field. Familiarity with FDA regulations, REMS program design, and database management systems is essential, along with certifications such as RAC (Regulatory Affairs Certification) being advantageous. Exceptional attention to detail, strong communication, and problem-solving skills help ensure effective collaboration with stakeholders and adherence to regulatory requirements. These skills are critical for minimizing drug-related risks, maintaining regulatory compliance, and safeguarding patient safety.

What is the difference between Risk Evaluation Mitigation Strategy Rems vs Safety Analyst?

AspectRisk Evaluation Mitigation Strategy RemsSafety Analyst
CredentialsOften requires certifications like OSHA, risk management, or safety-specific credentialsTypically requires safety certifications, OSHA training, or related degrees
Work EnvironmentPrimarily in industrial, manufacturing, or construction sites focusing on risk mitigationIn office, field, or industrial settings focusing on safety compliance and analysis
Industry UsageUsed in industries with regulatory risk management needs, such as manufacturing or constructionCommon in healthcare, manufacturing, and corporate safety programs

Risk Evaluation Mitigation Strategy Rems focus on developing and implementing strategies to reduce risks and ensure compliance with safety regulations. Safety Analysts assess safety protocols, analyze hazards, and recommend improvements. While both roles involve safety and risk management, Rems are more strategy-oriented, whereas Safety Analysts focus on analysis and compliance.

Infographic showing various Risk Evaluation Mitigation Strategy Rems job openings in the United States as of June 2026, with employment types broken down into 10% As Needed, 60% Full Time, 10% Temporary, and 20% Contract. Highlights an 90% In-person, and 10% Hybrid job distribution, with an average salary of $63,100 per year, or $30.3 per hour.
Director, US Commercial Risk Evaluation and Mitigation Strategies (REMS) Lead

Director, US Commercial Risk Evaluation and Mitigation Strategies (REMS) Lead

Agios Pharmaceuticals, Inc.

Cambridge, MA • On-site

Full-time

Posted 22 days ago

Job description

Director, US Commercial Risk Evaluation and Mitigation Strategies (REMS) Lead
Who we are:
At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture - one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion - because our differences shape how we hire, collaborate, and innovate. Our team's proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities. Our commitment is more than scientific - it's deeply personal, grounded in the meaningful connections we have built. To learn more, visit www.agios.com and follow Agios on LinkedIn and X.
The impact you will make:
The Director, US Commercial REMS Lead drives US Commercial strategies, activities, and insight gathering related to REMS (Risk Evaluation and Mitigation Strategies). The Director leads the development, implementation, and ongoing management of commercial related REMS activities to support compliance, patient safety, and effective execution across sales, field marketing, patient support, specialty distribution and other customer-facing teams. This role requires partnership with Commercial, Safety, Regulatory, Patient Services, and external vendors to translate REMS requirements into clear strategies, aligned tactics, and measurable outcomes.
What you will do:
  • Serve as the primary Commercial liaison on REMS topics across internal stakeholders and external partners. Attend select Governance and REMS core team meetings.
  • Lead US Commercial strategy, operations, and insight generation across Agios products/indications with a REMS.
  • Partner with Sales, Marketing, Commercial Training, Patient Services, Safety, Quality Assurance and Regulatory teams to align strategy, communications, and execution.
  • Lead the Commercial implementation of new REMS programs/modifications and ongoing compliance activities.
  • Participate in cross-functional workstreams to implement initiatives that improve REMS effectiveness and ensure ongoing success of the program.
  • Support the development of Commercial REMS training, communication, and materials that enable effective REMS understanding and pull-through.
  • Use multiple data sources to generate Commercial insights, refine strategy, and strengthen operational performance.
  • Partner with Commercial Operations and Analytics to design, track, and present key commercial REMS related metrics and KPIs to leadership.
  • Foster strong collaboration and accountability across internal teams and external partners.

What you bring:
  • Bachelor's degree in a scientific or business discipline.
  • 10+ years of experience in biotechnology or a related industry.
  • Demonstrated REMS experience within a Commercial environment.
  • Strong record of high performance in operational and cross-functional roles.
  • Experience leading large, complex, cross-functional initiatives.
  • Excellent communication skills and the ability to build strong partnerships.
  • Strong understanding of compliance requirements and guidance governing REMS programs.
  • High learning agility, sound judgment, and strong people skills.
  • Experience leading people, projects, or both.
  • MBA or other advanced degree preferred.
  • Experience in rare disease preferred.

Concerned that you don't check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other's differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you're excited about this role but your previous experience doesn't align perfectly with the job description, we still encourage you to apply. You may be just the right candidate for this role or another opening!
Work Location:
Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.
What we will give you:
  • Deliberate Development. Your professional growth as one of our top priorities.
  • We're all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you're at your best, we're at our best.
  • Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.
  • Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
  • The current base salary range for this position is expected to be between $183,549 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
  • Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
  • Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We're continuously looking to improve the inclusivity of our workforce.
  • Commitment to community. We're an active participant in the communities that surround us - the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.

Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.

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