Conducts baseline, routine, and focused audits comparing medical record documentation to reported CPT/HCPCS and ICD-10-CM codes.
Researches, interprets, and communicates federal and state laws and guidelines pertaining to CMS and Medicare.
Acts as an internal expert on coding issues to ensure compliance with state and federal regulations.
Privia Health is a technology-driven national physician enablement company that collaborates with medical groups, health plans, and health systems to optimize physician practices and improve patient experiences. The company is led by top industry talent and focuses on scalable operations and cloud-based technology to reduce healthcare costs.
Provide strategic quality oversight for global clinical operations, including decentralized clinical trials and patient-focused healthcare services.
Ensure compliance with global regulations, sponsor expectations, and established quality systems through risk management and continuous improvement.
Lead investigations, audits, and CAPA activities to support safe, efficient, and reliable clinical trial delivery.
The partner company is a mission-driven organization focused on improving access to healthcare solutions. They foster a supportive, inclusive, and collaborative work environment with a remote-first culture.
Oversee GCP quality systems and provide QA leadership for global clinical operations including decentralized trials.
Lead investigations, CAPAs, risk assessments, and audits to ensure regulatory compliance.
Review clinical documentation, support vendor qualification, and mentor QA staff.
WEP Clinical partners with biopharmaceutical sponsors to deliver clinical trial services, home health, and market access solutions. With over 15 years of global experience across 150+ countries, the company fosters a collaborative and mission-driven culture.
Supervise daily operations of clinical compliance auditors and specialists.
Assist in developing coordinated team processes and managing UM and PHM plan adherence.
Serve as clinical services liaison to senior management and ensure timely documentation.
Guidehealth is a data-powered healthcare company focused on operational excellence and value-based care. They emphasize empathy, AI, and collaboration, with a remote-first culture.
Responsible for submission planning and management of IND-related activities, including annual reports, DSURs, and CTA activities.
Manages the compilation, QC, and submission of INDs, BLAs, and amendments, and prepares routine regulatory documents.
Represents Regulatory Affairs on cross-functional teams, providing expertise and managing submission trackers.
Iovance Biotherapeutics is a biotechnology company pioneering tumor infiltrating lymphocyte (TIL) therapy for cancer. It is a small, fast-paced company with a collaborative and innovative culture.
Provide quality oversight of sterile drug product and finished drug product manufacturing, labeling, packaging, and distribution operations.
Review and approve batch production records, process validation documents, and quality system records such as deviations and change controls.
Support regulatory agency inspections and author NDA CMC sections to ensure compliance with GMP and GDP standards.
Amylyx Pharmaceuticals is a clinical-stage company focused on treating diseases with high unmet needs, such as post-bariatric hypoglycemia, Wolfram syndrome, and ALS. The company has an experienced team driven by core values of audacity, curiosity, authenticity, engagement, and accountability, fostering a culture of caring.
Lead one or more client policy initiatives with a team, including policy analysis, client communications, and project tracking.
Drive your development through an annual growth process in partnership with your supervisor and the learning and development team.
Participate in new business development through research, proposal content, and marketing materials.
BerryDunn is a professional services firm that has helped businesses, nonprofits, and government agencies since 1974. The firm is client-centered and people-first, with a focus on learning, development, and well-being, and has been recognized for its diverse and inclusive workplace culture.
Lead the execution and continuous improvement of quality management systems to ensure compliance with FDA, ICH, GCP, and ISO 9001 standards.
Manage electronic Quality Management System (eQMS) including document control, CAPA, risk management, and audit processes.
Provide quality oversight for clinical trial activities and software development lifecycle, collaborating with cross-functional teams.
The partner company is a fast-growing healthcare and life sciences organization focused on improving clinical research. It values collaboration, curiosity, and continuous improvement, and supports teams through scalable systems and risk management.
Collaborate with headquarters and internal teams to communicate US reprocessing and infection control needs.
Develop and support validation programs for endoscope reprocessing, working with independent labs and Fujifilm Tokyo.
Serve as the primary subject matter expert and educator on reprocessing and infection control for the Endoscopy Division.
FUJIFILM Healthcare Americas Corporation provides cutting-edge healthcare solutions including diagnostic imaging, endoscopic and surgical imaging, and in-vitro diagnostics. Fujifilm globally employs over 70,000 people and is guided by a purpose of giving the world more smiles.
Lead all operational and lifecycle management aspects of Regulatory CMC submissions supporting cell therapy development programs.
Develop and execute global regulatory CMC strategies aligned with program objectives and regulatory requirements.
Serve as Regulatory CMC lead on cross-functional program teams, providing strategic regulatory guidance for cell therapy development.
BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases. We are a small, mission-driven company with a rapidly growing, dynamic environment.