Lead external customer audits and utilization management oversight activities as a subject matter expert.
Analyze complex UM data, investigate findings, and prepare evidence-based responses for regulators and accreditation organizations.
Collaborate with operational, technical, and client-facing teams to drive compliance and process improvements.
This company is a healthcare organization specializing in utilization management and regulatory compliance. It operates with a remote team across the United States, fostering a collaborative and improvement-driven culture.
Lead U.S. and global regulatory strategies for oncology biologic development programs.
Prepare and manage Clinical Trial Applications, Marketing Applications, and regulatory amendments.
Collaborate with cross-functional teams to align regulatory plans and manage program risks.
A partner company is seeking a strategic regulatory affairs leader to support innovative oncology biologic and cell/gene therapy development programs. The company offers a fully remote environment with global regulatory exposure and cross-functional collaboration.
Lead the in-house pharmacovigilance function across clinical development and commercial products, owning the safety database, quality system, and compliance.
Serve as the senior safety physician, making benefit-risk determinations, adjudicating signals, and holding final safety decision authority.
Build and lead the PV team, set standards for AI-enabled safety processes, and ensure inspection readiness and health authority interactions.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. The company fosters a culture of trust, ownership, curiosity, and results, aiming to achieve the impossible together.
Lead clinical study strategy and execution for regulatory approvals and evidence initiatives.
Partner with stakeholders, investigators, and KOLs to design protocols and manage study progress.
Oversee monitoring, compliance, and data analysis while mentoring junior staff.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, known for da Vinci and Ion systems. Its team of engineers, clinicians, and innovators works to make surgery smarter, safer, and more human.
Lead end-to-end labeling activities across the product lifecycle for pre- and post-market products.
Guide global labeling strategy, document development, and cross-functional regulatory teams.
Provide strategic labeling expertise to support safe and effective product use and regulatory compliance.
A global regulatory affairs organization focused on pharmaceutical product labeling. It provides a collaborative, science-driven environment with cross-functional and international exposure.
Conduct internal and external quality audits for ICD-10 code abstraction and identify clinical documentation improvement opportunities.
Mitigate risk by validating Encounter Data Gathering Environment Server (EDGE) data and reviewing Risk Adjustment coding performance.
Maintain compliance with national coding standards and support CMS and Risk Adjustment Data Validation audits.
Oscar is a health insurance company built around a full-stack technology platform and a relentless focus on serving its members. Founded in 2012, it cultivates an inclusive environment where employees can be their authentic selves.
Execute the clinical audit program, including scheduling, planning, reporting, and resolution of audits.
Ensure compliance with worldwide regulations, ICH-GCP, AbbVie policies, and sponsor requirements.
Provide advice and support on GCP and quality topics to business partners and support inspections.
AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and aesthetics. It is a large biopharmaceutical company committed to integrity, innovation, and community service.
Review appeals of adverse benefit determinations within federal and state regulatory timeframes.
Apply medical policy, coding guidelines, and contractual requirements to assess coverage decisions.
Collaborate with medical divisions and respond to state insurance department inquiries regarding benefit complaints.
Arkansas Blue Cross and Blue Shield is a health insurance provider serving Arkansas. It is consistently ranked as one of the best places to work in Central Arkansas, with an inclusive culture and an average employee tenure of 10 years.
Serve as primary author and lead reviewer for CMC sections of late-stage and commercial regulatory submissions.
Provide hands-on CMC regulatory expertise across global filings, health authority interactions, and post-approval activities.
Collaborate with cross-functional teams to align regulatory strategy with scientific and compliance requirements.
The company is a biotechnology organization developing innovative cell therapies for late-stage and commercial stages. It offers a collaborative, entrepreneurial, and innovative work environment with a fast-paced, senior-level team.