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20 jobs similar to Senior Manager, REMS and Specialty Pharmacy Operations

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US

  • Serve as the designated Pharmacist in Charge and fulfill all related responsibilities.
  • Review and approve licensing submissions, renewals, and regulatory documentation.
  • Collaborate with the operations and compliance team to support ongoing compliance.

MD Exam is a healthcare organization specializing in sterile compounding operations. They are a growing company with an experienced team dedicated to compliance and patient safety.

US

  • Serve as the designated Pharmacist-in-Charge, reviewing licensing submissions and regulatory documentation.
  • Work with pharmacy operations and compliance team to support ongoing compliance and Board-related discussions.
  • Provide professional guidance and identify issues requiring follow-up or corrective action.

MD Exam is a growing healthcare organization with established sterile compounding operations. It offers an experienced team support and a collaborative culture focused on patient safety and compliance.

$190,989–$231,434/yr
United States 4w PTO

  • Own clinical supply chain order fulfillment, including labeling, packaging, and distribution of trial products.
  • Build and lead Clinical Supply Chain, Planning, and Warehousing teams with full regulatory compliance.
  • Develop sourcing strategies and manage vendors to ensure cost-effective, uninterrupted supply.

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, develops transformative radiopharmaceutical therapies for cancer patients. The company blends the pioneering spirit of an emergent biotech with global oncology expertise, fostering a collaborative multidisciplinary team where every member makes an immediate impact.

US

  • Manage integrated CMC timelines and drive alignment across technical, clinical, and regulatory teams.
  • Coordinate CDMO/CMO deliverables, budgets, and regulatory submission milestones.
  • Facilitate cross-functional meetings, track risks and action items, and provide clear program visibility.

Pulmovant is a clinical-stage biotechnology company focused on developing treatments for pulmonary diseases, with a lead candidate for pulmonary hypertension associated with interstitial lung disease. As part of the Roivant family, it fosters a collaborative and innovative culture, leveraging resources to advance its pipeline.

US

  • Ensure marketing, educational, and communications materials comply with FDA, FTC, USP, and state pharmacy regulations.
  • Lead cross-functional content reviews and provide practical, risk-based compliance guidance to teams.
  • Develop compliance SOPs, training resources, and auditable documentation to support scalable content operations.

Strive Pharmacy is a personalized compounding pharmacy that creates custom medications tailored to individual patient needs. The company is a growing team focused on disrupting the pharmaceutical industry with a human-centered approach and a collaborative culture.

France

  • Oversee GCP compliance, manage deviations and CAPAs, and conduct quality and TMF reviews.
  • Maintain inspection readiness and support CRO oversight per ICH E6(R3).
  • Collaborate with Data and Clinical teams to embed compliance into workflows and train teams.

Resilience Care is a French medtech founded in 2021, offering AI remote monitoring for oncology, gastroenterology, and psychiatry. It serves 35,000 patients across 200+ facilities with an agile, collaborative culture.

US

  • Execute and quality-check cross-channel campaigns across email, direct mail, and SMS.
  • Support new client launches, campaign configurations, and operational readiness checks.
  • Maintain client content, process Do Not Contact requests, and improve QA controls.

Virta Health is on a mission to reverse metabolic disease in one billion people through technology, personalized nutrition, and virtual care delivery. The company has raised over $350 million from top-tier investors and partners with health plans, employers, and government organizations, fostering a values-driven, remote-first culture.

US

  • Provide integrated support to patients and physicians to improve medication adherence and quality of care.
  • Review patient assessments and EMRs to develop care plans and optimize drug therapies.
  • Monitor adherence, oversee technicians, and ensure compliance with pharmacy regulations.

Shields Health Solutions provides integrated specialty pharmacy support to patients and physicians. The company emphasizes high-integrity, quality-focused teamwork and confidentiality in a remote work environment.

$154,128–$204,214/yr
US

  • Perform patient-specific medication reviews and develop recommendations for medical drug utilization management and Medication Therapy Management.
  • Resolve medication and pharmacy issues for members triaged from Member Services or other departments.
  • Act as subject matter expert for audits, quality improvement, and LEAN projects.

IEHP is a not-for-profit health plan dedicated to healing and inspiring the human spirit by providing quality healthcare services to members. They emphasize a supportive culture with career growth and wellness programs for their team.

$122,400–$172,800/yr
US Unlimited PTO

  • Provide clinical expertise and strategic recommendations to clients and internal teams on drug spend, formulary compliance, and clinical programs.
  • Act as a clinical liaison between Plan Operations and other departments, communicating formulary changes and program updates.
  • Analyze drug benefit designs, prepare clinical marketing materials, and support go-live activities for new client groups.

SmithRx is a venture-backed health-tech company disrupting the PBM sector with a next-generation drug acquisition platform. It has hundreds of thousands of members and a mission-driven, collaborative culture guided by integrity, courage, and togetherness.

$70,000–$95,000/yr
US

  • Lead end-to-end congress, webinar, and medical education event projects both onsite and remote.
  • Manage customer relationships and coordinate with stakeholders for seamless event execution.
  • Handle post-event analysis and deliver detailed reports with recommendations.

Onomi provides a platform for pharma teams to manage in-person and virtual engagements while capturing interactions in their CRM. Over 100 pharma companies use their solutions worldwide, and they aim to improve HCP experiences at lower cost.

$120,000–$140,000/yr
US

  • Lead complex client implementations, from customer use cases to success metrics and clinical workflows.
  • Train and educate customers on BioIntelliSense product offerings and value proposition.
  • Provide ongoing clinical support and post-implementation optimization while coordinating across teams.

BioIntelliSense is a healthcare technology company providing FDA-cleared wearable monitors, like the BioButton, and AI-driven analytics for early detection of patient decline. The company has a remote-first culture with a global team and offices in Colorado and California.

US

  • Manage end-to-end supply chain for specialty medications and clinical supplies across infusion clinics.
  • Develop and maintain inventory processes, including ordering controls, par-level optimization, and waste reduction.
  • Partner with finance, pharmacy, and manufacturer relations to evaluate purchasing opportunities and contract performance.

Nira Medical is a national partnership of physician-led, patient-centered independent practices dedicated to advancing neurological care. They support practices with cutting-edge technology, clinical research, and a collaborative network, scaling their teams and services as they grow.

US

  • Develop and maintain integrated project plans for global regulatory submissions, ensuring adherence to scope, timelines, budgets, and quality standards.
  • Act as the primary regulatory timeline contact across Clinical, Nonclinical, CMC, Quality, and Commercial functions, fostering collaboration and alignment.
  • Identify and mitigate project risks, prepare teams for agency meetings, and lead responses to regulatory queries from global health authorities.

Centessa Pharmaceuticals is a clinical-stage company developing orexin receptor 2 agonists for narcolepsy and other sleep-wake disorders. As a wholly owned subsidiary of Eli Lilly and Company, it shares a culture of caring and impact with over 50,000 employees.

US

  • Triage clinical program calls, schedule consultations, and conduct outreach to members, prescribers, and pharmacies.
  • Monitor outreach queues, document case activities, and escalate issues to ensure timely completion of clinical programs.
  • Maintain compliance with HIPAA and internal SOPs while providing compassionate, professional support to members and providers.

Judi Health is a health technology company providing benefit administration solutions to employers, unions, health plans, and government entities. They consolidate pharmacy and medical benefits on a unified platform, leveraging AI-powered care delivery to enhance efficiency and service. The company is a growing startup focused on transforming healthcare infrastructure.

$75,400–$165,954/yr
US

  • Develops, manages, and monitors corporate compliance programs that promote ethical behavior and mitigate risk.
  • Leads risk assessments, audits, and regulatory interactions, including preparing reports and responding to inquiries.
  • Builds relationships with internal and external stakeholders to drive compliant outcomes and manages operational compliance activities.

Omnicare is a leading provider of pharmacy services to long-term care facilities nationwide, supporting skilled nursing, assisted living, and other institutional care settings. The organization fosters a culture of care, innovation, and accountability, with a focus on quality and safety in everything it does.

US Unlimited PTO

  • Collaborate with the Clinical Operations team to support timely conduct of clinical studies according to protocols, GCP, SOPs, and regulations.
  • Lead operational management for assigned regions and sites, including vendor management and oversight of CRO monitors.
  • Contribute to the development and maintenance of study documents and ensure the Trial Master File is complete and inspection-ready.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines for patients with genetic diseases and cancers with clear genetic drivers. Founded in 2015, the company has built a portfolio of 20+ drug development programs spanning preclinical to late-stage development across multiple therapeutic areas.

US

  • Lead product safety surveillance strategies and risk management for investigational products.
  • Oversee medical review of safety data and ensure compliance with global pharmacovigilance regulations.
  • Build pharmacovigilance infrastructure and manage vendor partnerships as the company grows.

Oruka Therapeutics develops novel biologics for chronic skin diseases like plaque psoriasis. It is a growing biotechnology company with a startup culture focused on making a difference.

$80,000–$93,000/yr
US Unlimited PTO

  • Partner with Customer Success to deliver measurable 340B outcomes for a portfolio of clients.
  • Lead implementations, manage timelines, and ensure consistent execution across client workflows.
  • Analyze data to surface trends, optimize referral capture, and drive client performance.

NuvemRx helps community health providers simplify pharmacy operations with software, intelligence, and expert support. It is a fast-growing, mission-driven company that values ownership, collaboration, integrity, and service.

Global

  • Lead safety evaluations and benefit-risk assessments for assigned products.
  • Provide medical leadership for pharmacovigilance activities across development and marketed products.
  • Support regulatory submissions and health authority interactions, including preparing responses to RFIs.

Alphanumeric is a staffing and recruiting company that places professionals in contract roles with top organizations. This role is a 1-year contract with a major pharmaceutical company, supporting its global Safety Evaluation & Risk Management function.