Remote Regulatory affairs Jobs

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Manager, Clinical Quality Compliance

ICON โš•๏ธ๐Ÿ”ฌ๐Ÿงช

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.

New Manager, Market Access (Central)

Calyxo, Inc. โš•๏ธ๐Ÿ”ฌ๐Ÿงฌ
$110,000โ€“$125,000
USD/year

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.

Manager, Food Safety

Sodexo ๐Ÿฝ๏ธ๐Ÿข๐ŸŒ
$62,300โ€“$94,270
USD/year

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.

Global Studies Associate

ICON โž•๐ŸŒ๐Ÿ’ก

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).

Clinical Quality Compliance Lead

ICON โš•๏ธ๐Ÿงช๐Ÿ”ฌ

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.

Patient Privacy Compliance Specialist

PrivacyPro ๐Ÿฅโš•๏ธ๐Ÿ›ก๏ธ
$60,000โ€“$75,000
USD/year
US Unlimited PTO

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.

Site Activation Partner

ICON ๐ŸŒ๐Ÿงช๐Ÿ”ฌ

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.

Senior Market Access & Reimbursement

Convatec โš•๏ธ๐Ÿ”—๐ŸŒ

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.

Clinical Trial Management Associate

Akero Therapeutics ๐Ÿงช๐Ÿ”ฌ๐Ÿ’Š
$103,000โ€“$114,000
USD/year

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.

Senior Manager, Healthcare Compliance

GeneDx ๐Ÿงฌ๐Ÿงช๐Ÿ”ฌ
$155,000โ€“$175,000
USD/year

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.