Lead medical information activities for healthcare programs, ensuring high-quality handling of inquiries.
Ensure accurate documentation and triage of medical requests, adverse events, and product complaints.
Manage multiple projects and maintain empathetic customer communication across channels.
The hiring company focuses on delivering medical information and healthcare support programs. It operates with a remote team culture, emphasizing collaboration and professional development.
Develops and drives regulatory strategy for FDA Pharma and IVDR initiatives.
Represents the regulatory function on cross-functional teams and interacts with regulatory authorities.
Coordinates regulatory submissions and ensures compliance with global requirements.
Natera is a clinical genetic testing company specializing in non-invasive cell-free DNA and liquid biopsy testing. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.
Lead Loyal's overall regulatory strategy across CMC and clinical activities, from early development through post-approval lifecycle management.
Act as the primary liaison with global regulatory agencies and own approval submission strategy and execution.
Build and scale a high-performing regulatory organization, establishing governance frameworks and eCTD publishing capabilities.
Loyal is a clinical stage veterinary medicine company developing longevity drugs for dogs. It is a well-funded startup led by a first gen female CEO, with a culture focused on innovation, transparency, and empathy for all life.
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.
Establish and maintain a system to collect all suspected adverse reaction reports for company products.
Ensure requests from competent authorities for benefit-risk information are answered fully and promptly.
Oversee safety profiles, emerging safety concerns, and post-authorisation safety study commitments.
PrimeVigilance is a mid-size pharmacovigilance service provider and part of Ergomed PLC, supporting pharma and biotech partners with drug safety, regulatory affairs, and quality assurance. With staff across Europe, North America and Asia, it values well-being.
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.