Remote Regulatory affairs Jobs

As a Manager, Clinical Quality Compliance, you will perform and lead audits of clinical investigator sites, internal GCP systems/processes, external vendors, and clinical trial documents. Identify and report systematic issues and areas for improvement. Ensure appropriate corrective and preventative actions have been committed to by auditees. Approximately 50% travel is required.

Support the execution of reimbursement strategy to create a favorable reimbursement climate for Calyxo products by regularly interacting with sales management personnel. Be an expert on coding, coverage, and payment as they relate to Calyxo and competitive products. Assist in the implementation of reimbursement strategy and tactics to support the Calyxo sales force.

Ensures corporate and regulatory compliance for the company's quality assurance and food safety initiatives by proactively providing technical expertise, training, and operational support across business segments. Leads incident response efforts and supports third-party food safety audit programs. Supports successful onboarding of new units and operational leaders, requiring 50%-80% travel.

Assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Global Study Team to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives. Your responsibilities include supporting Global Study Director (GSD) / Global Study Associate Director (GSAD) and Global Study Managers (GSMs) by completing delegated study work, initiating and leading the set-up of the electronic Trial Master File (eTMF).

Provide just-in-time guidance to study teams on key operating model processes and required documentation, prioritizing real-time inspection readiness. Manage and guide teams on inspection readiness planning, including developing and maintaining inspection readiness plans and tools in collaboration with cQA and GCP Excellence in Clinical Trials leadership.

The Compliance Specialist is part of the Bluesight Professional Services team and focuses on providing compliance consultative services using the Bluesight Health Compliance Analytics platform. Responsibilities include providing ongoing case triage and review services, initial investigations of new cases, documentation, and internal support.

Play a key role in improving the lives of patients by accelerating the development of our customers drugs and devices through innovative solutions. You will be dedicated resource to one of our clients, be embedded in their working environment, systems and processes. Collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation.

The Senior Market Access & Reimbursement will drive reimbursement strategy for Advanced Wound Care (AWC) products ensuring alignment with the Center of Excellence's goals to secure sustainable reimbursement, proactively address policy risks, and integrate reimbursement requirements into clinical trial designs. This role requires close collaboration with clinical development, regulatory affairs, and commercial teams to embed market access considerations across the product life cycle.

The Clinical Trial Management Associate (CTMA) is a key member of Clinical Operations and will closely partner with the Senior Clinical Trial Manager. Accountable for study level tracking as assigned by the Clinical Project Manager; e.g. monitor visit tracking and sample tracking. Ensures patient enrollment activities are conducted in a timely manner and is comfortable communicating with site personnel. Provides study level information to enable accurate and efficient supply of clinical product to the sites.

Oversee the development, implementation, and maintenance of the healthcare compliance program at GeneDx, a commercial genomic testing laboratory. Ensure that laboratory operations, billing practices, and regulatory reporting align with applicable healthcare laws, regulations, and accreditation standards. Serve as a subject matter expert and key advisor to internal stakeholders on regulatory risk, operational compliance, and ethical business conduct.