The Program Manager for the REMS (Risk Evaluation and Mitigation Strategies) program will be responsible for the oversight and management of multiple REMS components, including REMS CAR-T, REMS MAVA ...
Quick apply
The Program Manager for the REMS (Risk Evaluation and Mitigation Strategies) program will be responsible for the oversight and management of multiple REMS components, including REMS CAR-T, REMS MAVA ...
Quick apply
The Program Manager for the REMS (Risk Evaluation and Mitigation Strategies) program will be responsible for the oversight and management of multiple REMS components, including REMS CAR-T, REMS MAVA ...
This role will support stakeholder needs for ongoing REMS topics, continuing education, audit support, and new certifications. They will work closely with all Alexion field roles as well as with the ...
This role will support stakeholder needs for ongoing REMS topics, continuing education, audit support, and new certifications. They will work closely with all Alexion field roles as well as with the ...
Somerville, NJ ยท On-site
$30/hr
Serve as SME for REMS Evaluation products, providing analytics and guidance to improve service and compliance * Build collaborative relationships across teams and business partners * Identify ...
Quick apply
Somerville, NJ ยท On-site
$30/hr
Serve as SME for REMS Evaluation products, providing analytics and guidance to improve service and compliance * Build collaborative relationships across teams and business partners * Identify ...
Cary, NC ยท On-site
$40 - $54.50/hr
Risk Evaluation and Mitigation Strategy (REMS) Clinical Nurse Educator The Risk Evaluation and Mitigation Strategy (REMS) Clinical Nurse Educator provides high-quality patient care and counseling to ...
Cary, NC ยท On-site
$40 - $54.50/hr
Risk Evaluation and Mitigation Strategy (REMS) Clinical Nurse Educator The Risk Evaluation and Mitigation Strategy (REMS) Clinical Nurse Educator provides high-quality patient care and counseling to ...
$38.50 - $52.50/hr
Risk Evaluation and Mitigation Strategy (REMS) Clinical Nurse Educator The Risk Evaluation and Mitigation Strategy (REMS) Clinical Nurse Educator provides high-quality patient care and counseling to ...
Quick apply
$38.50 - $52.50/hr
Risk Evaluation and Mitigation Strategy (REMS) Clinical Nurse Educator The Risk Evaluation and Mitigation Strategy (REMS) Clinical Nurse Educator provides high-quality patient care and counseling to ...
Understand specifics and support questions associated with PSF submission, REMS enrollment, payer policies (e.g., PAs process and denial, and appeals), patient reimbursement (e.g., Co-pay, PAP ...
Understand specifics and support questions associated with PSF submission, REMS enrollment, payer policies (e.g., PAs process and denial, and appeals), patient reimbursement (e.g., Co-pay, PAP ...
Understand specifics and support questions associated with PSF submission, REMS enrollment, payer policies (e.g., PAs process and denial, and appeals), patient reimbursement (e.g., Co-pay, PAP ...
Understand specifics and support questions associated with PSF submission, REMS enrollment, payer policies (e.g., PAs process and denial, and appeals), patient reimbursement (e.g., Co-pay, PAP ...
Knowledge on Risk Evaluation and Mitigation Strategies (REMS), Structured Query Language (SQL), eXtensible Markup Language (XML), and the FDA Structured Product Labeling (SPL). Ability to understand ...
Knowledge on Risk Evaluation and Mitigation Strategies (REMS), Structured Query Language (SQL), eXtensible Markup Language (XML), and the FDA Structured Product Labeling (SPL). Ability to understand ...
Las Vegas, NV ยท Hybrid
Partner with REMS administrators to ensure REMS compliance and conduct routine internal audits * Support quality requirements associated with REMS programs, limited distribution drug (LDD) networks ...
Las Vegas, NV ยท Hybrid
Partner with REMS administrators to ensure REMS compliance and conduct routine internal audits * Support quality requirements associated with REMS programs, limited distribution drug (LDD) networks ...
Las Vegas, NV ยท On-site
Partner with REMS administrators to ensure REMS compliance and conduct routine internal audits * Support quality requirements associated with REMS programs, limited distribution drug (LDD) networks ...
Las Vegas, NV ยท On-site
Partner with REMS administrators to ensure REMS compliance and conduct routine internal audits * Support quality requirements associated with REMS programs, limited distribution drug (LDD) networks ...
Knowledge on Risk Evaluation and Mitigation Strategies (REMS), Structured Query Language (SQL), eXtensible Markup Language (XML), and the FDA Structured Product Labeling (SPL). Ability to understand ...
Knowledge on Risk Evaluation and Mitigation Strategies (REMS), Structured Query Language (SQL), eXtensible Markup Language (XML), and the FDA Structured Product Labeling (SPL). Ability to understand ...
Oversee and administer Spravato (esketamine) treatments, ensuring adherence to REMS (Risk Evaluation and Mitigation Strategy) program guidelines. * Monitoring and Follow-Up: Closely monitor patients ...
New
Oversee and administer Spravato (esketamine) treatments, ensuring adherence to REMS (Risk Evaluation and Mitigation Strategy) program guidelines. * Monitoring and Follow-Up: Closely monitor patients ...
New
Oversee and administer Spravato (esketamine) treatments, ensuring adherence to REMS (Risk Evaluation and Mitigation Strategy) program guidelines. * Monitoring and Follow-Up: Closely monitor patients ...
New
Oversee and administer Spravato (esketamine) treatments, ensuring adherence to REMS (Risk Evaluation and Mitigation Strategy) program guidelines. * Monitoring and Follow-Up: Closely monitor patients ...
New
Oversee and administer Spravato (esketamine) treatments, ensuring adherence to REMS (Risk Evaluation and Mitigation Strategy) program guidelines. * Monitoring and Follow-Up: Closely monitor patients ...
New
Oversee and administer Spravato (esketamine) treatments, ensuring adherence to REMS (Risk Evaluation and Mitigation Strategy) program guidelines. * Monitoring and Follow-Up: Closely monitor patients ...
New
Oversee and administer Spravato (esketamine) treatments, ensuring adherence to REMS (Risk Evaluation and Mitigation Strategy) program guidelines. * Monitoring and Follow-Up: Closely monitor patients ...
New
Oversee and administer Spravato (esketamine) treatments, ensuring adherence to REMS (Risk Evaluation and Mitigation Strategy) program guidelines. * Monitoring and Follow-Up: Closely monitor patients ...
New
Oversee and administer Spravato (esketamine) treatments, ensuring adherence to REMS (Risk Evaluation and Mitigation Strategy) program guidelines. * Monitoring and Follow-Up: Closely monitor patients ...
New
Oversee and administer Spravato (esketamine) treatments, ensuring adherence to REMS (Risk Evaluation and Mitigation Strategy) program guidelines. * Monitoring and Follow-Up: Closely monitor patients ...
New
Oversee and administer Spravato (esketamine) treatments, ensuring adherence to REMS (Risk Evaluation and Mitigation Strategy) program guidelines. * Monitoring and Follow-Up: Closely monitor patients ...
New
Oversee and administer Spravato (esketamine) treatments, ensuring adherence to REMS (Risk Evaluation and Mitigation Strategy) program guidelines. * Monitoring and Follow-Up: Closely monitor patients ...
New
Basking Ridge, NJ ยท On-site
Provide end-to-end safety consultation impacting REMS products from a quality perspective. Provide regular updates to management on the PV QA strategy and recommend refinements to objectives as ...
Basking Ridge, NJ ยท On-site
Provide end-to-end safety consultation impacting REMS products from a quality perspective. Provide regular updates to management on the PV QA strategy and recommend refinements to objectives as ...
Basking Ridge, NJ ยท On-site
Provide end-to-end safety consultation impacting REMS products from a quality perspective. Provide regular updates to management on the PV QA strategy and recommend refinements to objectives as ...
Basking Ridge, NJ ยท On-site
Provide end-to-end safety consultation impacting REMS products from a quality perspective. Provide regular updates to management on the PV QA strategy and recommend refinements to objectives as ...
Basking Ridge, NJ ยท On-site
Provide end-to-end safety consultation impacting REMS products from a quality perspective. Provide regular updates to management on the PV QA strategy and recommend refinements to objectives as ...
Basking Ridge, NJ ยท On-site
Provide end-to-end safety consultation impacting REMS products from a quality perspective. Provide regular updates to management on the PV QA strategy and recommend refinements to objectives as ...
$16.11 - $18.51
3% of jobs
$18.51 - $20.91
5% of jobs
$20.91 - $23.32
6% of jobs
$23.32 - $25.72
9% of jobs
$26.02 is the 25th percentile. Wages below this are outliers.
$25.72 - $28.13
11% of jobs
$28.13 - $30.53
15% of jobs
The median wage is $30.62 / hr.
$30.53 - $32.93
14% of jobs
$35.09 is the 75th percentile. Wages above this are outliers.
$32.93 - $35.34
13% of jobs
$35.34 - $37.74
11% of jobs
$37.74 - $40.14
10% of jobs
$40.14 - $42.55
3% of jobs
$16
$31
$42
A REMS Coordinator or Specialist is responsible for managing and implementing Risk Evaluation and Mitigation Strategies to comply with FDA regulations and ensure patient safety. Their daily tasks often include coordinating data collection, preparing compliance reports, training healthcare providers or internal staff on REMS requirements, and monitoring adherence to risk management protocols. They frequently collaborate with cross-functional teams such as regulatory affairs, safety, clinical operations, and external partners. This role requires staying up-to-date with evolving regulations and communicating any required process updates to stakeholders, making organization and flexibility key to success.
To thrive as a REMS (Risk Evaluation and Mitigation Strategies) Coordinator or Specialist, you need experience in pharmaceutical compliance, clinical research, and regulatory affairs, often backed by a bachelor's degree in a life science field. Familiarity with FDA regulations, REMS program management software, and documentation systems is essential. Strong attention to detail, communication skills, and the ability to collaborate across multidisciplinary teams are vital for the role. These competencies ensure that REMS programs are implemented effectively to protect patient safety and maintain regulatory compliance.
A REMS (Risk Evaluation and Mitigation Strategy) job typically involves managing drug safety programs required by the FDA to ensure that the benefits of certain medications outweigh their risks. Professionals in this role work on designing, implementing, and monitoring strategies like patient education, provider training, and restricted distribution programs. They often collaborate with regulatory agencies, healthcare providers, and pharmaceutical companies to ensure compliance with REMS requirements.

Other
Re-posted 13 days ago
Job Description
Title: Senior Risk and Compliance PM
Location: Lawrenceville, New Jersey (Hybrid)
Duration: 12+ Months
Top skill is Regulatory Expertise in Pharma environment: Previous experience with regulatory compliance programs, particularly in REMS or similar risk management initiatives.
Overview:
The Program Manager for the REMS (Risk Evaluation and Mitigation Strategies) program will be responsible for the oversight and management of multiple REMS components, including REMS CAR-T, REMS MAVA, and REMS IMiDs. This role requires a strategic leader with strong project management skills to ensure compliance, efficiency, and continuous improvement within the REMS program.
Key Responsibilities:
Program Oversight:
Manage and oversee the REMS CAR-T, REMS MAVA, REMS IMiDs, and REMS CELMoDs programs, ensuring alignment with regulatory requirements and business objectives.
Drive program outcomes by ensuring each program meets its intended deliverables within expected timelines.
Provide regular, detailed reporting on program status, progress, and key milestones to stakeholders.
CAPA Management: Oversee resolution of Corrective and Preventive Actions (CAPAs) resulting from the Global REMS IMiDs investigation triggered by a P1 incident in January 2025.
Management of Post Go-Live Issues for CAMUNDA: Oversee post-production activities for the Global IMiDs REMS platform that transitioned to a cloud-based system on January 27, 2025. This includes:
- Monitoring system performance and stability in the cloud environment
- Managing ongoing optimization efforts and address any technical issues
- Coordinating with IT teams on maintenance, updates, and enhancements
- Ensure business continuity and user adoption of the cloud-based solution
SWAT Team Coordination: Collaborate with the SWAT team, including members from Ernst & Young, to analyze program and business processes, identifying opportunities for efficiency and process improvements.
Stakeholder Engagement & Communication:
Engage with internal and external stakeholders to align program objectives, priorities, and deliverables.
Facilitate clear communication channels between internal teams and external partners.
Deliver integrated program-level reporting tailored to stakeholder needs by:
o Providing timely status updates with appropriate level of detail for each audience.
o Balancing sufficient context with clear high-level messaging to ensure key takeaways are clear
o Highlighting critical information without overwhelming recipients with unnecessary details
o Adapting communication style and content to effectively inform decision-makers at all organizational levels
Coordinate and manage regular governance sessions with key stakeholders (such as Steering Committee meetings) by:
o Developing structured agendas
o Capturing and documenting decisions, action items, and accountabilities
o Following up on commitments to ensure momentum is maintained between meetings
o Serving as the primary escalation point for critical program updates or concerns
Risk Governance:
Implement proactive risk identification and mitigation strategies
Lead root cause analysis for any program issues
Develop contingency plans for high-risk areas within the REMS ecosystem
Qualifications:
Educational Background: Bachelor's degree in a relevant field (e.g., Business Administration, Project Management, Healthcare Management). Advanced degree preferred.
Professional Experience:
Industry Experience: Minimum of 10 years of experience in program management, preferably within the healthcare or pharmaceutical industry
System Management: Demonstrated experience in post-implementation system management
Regulatory Expertise: Previous experience with regulatory compliance programs, particularly in REMS or similar risk management initiatives
Thanks & Regards
Deepak Panday
Sr. Technical Recruiter
Email- Deepak@stellentit.com
Sourced by ZipRecruiter
Stellent IT, based in St Augustine, Florida, USA, is a renowned company in the IT sector whose primary focus is providing top-tier IT consulting and staffing services. Stellent IT's expertise lies not just in fulfilling IT staffing needs but in offering comprehensive technological solutions that enhance and drive business performance. Despite the limited information about their founding history, the company has earned a name for itself in the IT industry due to its commitment to quality and consistent delivery. With a mission centered around helping businesses efficiently navigate the IT landscape by providing strategic technology-inspired solutions, Stellent IT prides itself as a leader in its field.
Recruiting and staffing services
11 - 50 Employees
St Augustine, FL, US