Average salary: $152,991 /yearly
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- You are the first to roll up your sleeves and work with endless energy until you solve the unsolvable, beat the unbeatable and come out on top. In this role, you will manage the overall solution development process and ensure there is integration both within and across...SuggestedWork experience placementFlexible hours
- Role Description The REMS Business Analyst serves as the critical liaison between business stakeholders, sponsors, and IT teams to ensure the successful delivery of Risk Evaluation and Mitigation Strategy (REMS) programs and supporting REMS solutions. This role is responsible...SuggestedFull time
MMS
Remote6 days ago - Role Description ~Support the day-to-day operations of the U.S. FDA–mandated REMS programs, ensuring compliance with regulatory requirements and internal governance standards. ~Provide strategic oversight of REMS initiatives, ensuring timely execution of program objectives...SuggestedFull timeRemote workFlexible hours
Jazz Pharmaceuticals
Remotea month ago - ...Mastery of disease state and product information communicated in a compliant manner consistent with the FDA-approved product labeling and REMS program Customer Engagement – Engage with account personnel to prepare for sales call, uncover needs and opportunities,...SuggestedFull timeWork at officeLocal areaNight shift
Braeburn Inc
Remote12 hours ago - ...Monitor therapy effectiveness and safety, identify optimization and intervene as appropriate. Support quality‑improvement and REMS initiatives. Provide recommendations to operations by supporting teammates as needed with complex prior authorizations, improving...SuggestedFull timeWork at officeRemote work
Shields Health Solutions
Remote2 days ago - ...Mastery of disease state and product information communicated in a compliant manner consistent with the FDA-approved product labeling and REMS program Customer Engagement – Engage with account personnel to prepare for sales call, uncover needs and opportunities,...SuggestedFull timeWork at officeLocal areaNight shift
Braeburn
Remote9 days ago - ...safety reports (e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR) We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical...SuggestedRemote jobFull timeContract workWork at office
- ...initiatives when applicable. Participate in quality improvement initiatives by actively participating in clinical outcome studies, REMs compliance/reporting , and ACP-related process improvement projects. Optimize resources and workflows with supporting roles...SuggestedFull timeWork at officeRemote work
Shields Health Solutions
Remote13 days ago $120k - $150k
...preferred Experience in CNS / psychiatry, specialty pharmaceutical, or complex treatment categories preferred Experience with REMS products or novel treatment delivery models preferred Ability to synthesize complex clinical and market data into actionable...SuggestedFull timeFlexible hoursDefinium Therapeutics
Remote15 days ago- ...Mastery of disease state and product information communicated in a compliant manner consistent with the FDA-approved product labeling and REMS program Customer Engagement – Engage with account personnel to prepare for sales call, uncover needs and opportunities,...SuggestedFull timeWork at officeLocal area
Braeburn
Remote29 days ago - ...Partnerships Own relationships with specialty pharmacy and distribution partners (wholesalers, GPO contacts) Support navigation of REMS requirements, limited-distribution drug (LDD) access, and specialty pharmacy accreditation-adjacent partnerships Specialty...SuggestedFull time
Leap Health
Remote29 days ago - ...specialty drug pipeline planning and manufacturer engagement strategies. Ensure compliance with manufacturer, regulatory, FDA , and REMS requirements. Partner with Contract and Network Management teams to support implementation of manufacturer programs. Lead...SuggestedFull timeContract workWork at officeLocal area
Shields Health Solutions
Remote29 days ago - ...malignancies. Track conference activity ( ASH , ASCO , EHA , EBMT , TCT ), clinical trial registries, FDA/EMA label and REMS changes, pricing and coverage signals, and competitor activity. Develop monthly CI briefings and ad-hoc competitive alerts;...SuggestedFull timeLocal areaRemote work
Orca Bio
Remote29 days ago - ...specialty drug pipeline planning and manufacturer engagement strategies. Ensure compliance with manufacturer, regulatory, FDA , and REMS requirements. Partner with Contract and Network Management teams to support implementation of manufacturer programs. Lead...SuggestedFull timeContract workWork at officeLocal area
Shields Health Solutions
Remotea month ago - ...malignancies. Track conference activity ( ASH , ASCO , EHA , EBMT , TCT ), clinical trial registries, FDA/EMA label and REMS changes, pricing and coverage signals, and competitor activity. Develop monthly CI briefings and ad-hoc competitive alerts;...SuggestedFull timeLocal areaRemote work
Orca Bio
Remotea month ago - ...Partnerships Own relationships with specialty pharmacy and distribution partners (wholesalers, GPO contacts) Support navigation of REMS requirements, limited-distribution drug (LDD) access, and specialty pharmacy accreditation-adjacent partnerships Specialty...Full time
Leap Health
Remotea month ago $59k
...00 KPI variable bonus opportunity) ~ Medical, Dental, Vision ~ Life Insurance ~401k ~ Paid Time Off ~ Company Car * #LI-Rem *#LI-Remote In the event that COVID-19 vaccine mandates issued by the federal government, or by state or local government become...Full timeWork at officeLocal areaRemote workFlexible hours$60.47k - $79.86k
...~$60,471.00 - $79,861.00 + 8% Bonus opportunity ~ Medical, Dental, Vision ~ Life Insurance ~401k ~ Paid Time Off * #LI-Rem #LI-Remote In the event that COVID-19 vaccine mandates issued by the federal government, or by state or local government become...Full timeWork at officeLocal areaRemote workFlexible hours$180k - $235k
...through treatment preparation and ongoing follow-up. You will help design compliant, scalable patient journeys while supporting potential REMS requirements and launch readiness. Working across Regulatory, Legal, Medical Affairs, Marketing, Sales, Market Access, and other...Full timeFlexible hours$181k - $235k
...responses to Health Authority safety queries. Contribute to risk management activities, including Risk Management Plans (RMPs), REMS development, and risk minimization measure effectiveness assessments. Participate in safety governance bodies, including...Full timeLocal areaRemote workFlexible hoursNight shift$180k - $235k
...goals. This role will drive how Definium Patient Services supports patients across onboarding, treatment preparation, all aspects of REMS, and ongoing support, while ensuring all initiatives meet stringent regulatory standards (e.g., FDA). This role is responsible for...Full timeFlexible hours- ...in project delivery across all PMs and Sr. PMs. ~Develop and execute overall program strategy aligned with client objectives and REMS’ operational standards. ~Establish, maintain, and continually refine program goals, success criteria, and performance methodologies...Full timeWork experience placementWork from homeFlexible hours
RE Management Solutions
Remote8 days ago $250k - $295k
...in market access, field reimbursement, or site-of-care/account management within specialty pharmaceuticals, cell & gene therapy, or REMS-required products Minimum 8 years of people leadership experience, including leading leaders (managing managers/directors)...Full timeFlexible hours$190k - $230k
...interactions are coordinated, purposeful, and aligned with account priorities and patient needs and broader commercial strategy Understand REMS program requirements and restricted distribution models associated with Sabril® In the future, potential to be responsible for...Full timeWork at officeLocal areaFlexible hours- ...review of sub-custodian arrangements, concentration thresholds, and contingency arrangements Regulatory Engagement & Remediation ("REM"): Support the preparation and submission of regulatory reports to FSRA, including periodic risk-related disclosures, ad-hoc RFI...Full timeWork from homeOverseas
Binance
Remote16 days ago - .../distributor, infusion provider network, PBM, or integrated care company (preferred) ~Familiarity with prior authorization (PA), REMS programs, limited-distribution drugs, and specialty drug distribution (preferred) ~Track record leading provider or partner network...Full timeImmediate start
Leap
Remotea month ago
