Provide expert knowledge on day-to-day clinical pharmacology workflows for regulatory submissions.
Identify common tasks and problems where AI can add value in pharmacology workflows.
Generate and review ground-truth artifacts to evaluate AI platform outputs for regulatory-grade quality.
Edison Scientific builds and commercializes AI agents for science to accelerate scientific discovery. They are assembling a team of top researchers and engineers across AI and biology to build an AI scientist, fostering a fast-moving, mission-driven culture.
Serve as subject matter expert defining gold standard for regulatory content on an AI platform.
Ensure outputs reflect current agency expectations and are ready for global submission.
Work flexibly 5–20 hours per week in a remote, US-based role.
Edison Scientific builds and commercializes AI agents for science. They are assembling a team of top researchers and engineers across AI and biology with a fast-moving, mission-driven culture.
Act as a domain authority establishing benchmarks for AI-driven statistical results.
Provide knowledge sharing about day-to-day workflows and regulatory submissions.
Identify and correct discrepancies in data quality and generate reference artifacts.
Edison Scientific builds and commercializes AI agents for science. We are assembling a team of top researchers and engineers across AI and biology to build an AI scientist.
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
Collaborating with investigators and site staff to facilitate smooth study conduct.
ICON is a global healthcare intelligence and clinical research organization dedicated to accelerating the development of new medicines and treatments. As a values-driven company, ICON fosters a culture of integrity, collaboration, agility, and inclusion, employing a diverse workforce.
Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting for clinical trials.
Serve as the internal project manager for assigned oncology disease groups, providing timely updates and regulatory guidance.
Manage study activation processes and act as liaison between sponsors, investigators, and internal departments.
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. Winship Cancer Institute is Georgia's only NCI-designated Comprehensive Cancer Center, dedicated to discovering cures for cancer and providing innovative therapies.
Provide study oversight as primary liaison between CRAs, internal staff, site staff, client personnel, and external vendors.
Ensure clinical monitoring activities comply with SOPs, regulations, GCP, KPIs, and study-specific requirements.
Develop and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996, supporting research behind innovative treatments in pharmaceutical, biotech, and medical device industries. They foster a collaborative community where team members feel valued, supported, and empowered to make a meaningful impact on global health.
Provide advisory on clinical development analytics, leveraging 10+ years of pharma experience.
Lead adoption of data tools and dashboards across clinical development teams.
Translate between data engineering and clinical stakeholders to optimize drug development data.
Edison Scientific is a biotech and pharma analytics firm focused on clinical development data. They offer a mission-driven culture with regular team offsites and a fast-moving environment.
Independently negotiate and manage complex clinical trial agreements, site budgets, and amendments with minimal training.
Partner cross-functionally with Clinical Operations, Finance, and Legal to ensure compliant and timely study startup.
Serve as subject matter expert and escalation point for contract and budget issues across global studies.
CareDx is a leading precision medicine solutions company focused on improving outcomes for transplant patients through innovative diagnostics, services, and digital health solutions. As a leader in genomics-based transplant information, the company offers a competitive Total Rewards package and fosters a mission-driven culture where employees directly impact patient lives.
Help build your dream AI-enabled authoring platform by guiding product and engineering teams on source data mapping, document logic, and summary execution.
Define document generation frameworks for regulatory-grade documents, starting with clinical trial results and scaling to broader submissions.
Establish objective quality criteria, review protocols, and verification frameworks to ensure outputs meet global regulatory expectations.
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, surpassing $3 billion in revenue, we are a public benefit corporation with a flexible work environment and a commitment to employee success.
Leads writing and preparing clinical and regulatory documents for drug and device development.
Coordinates review, approval, and quality control across functions to ensure compliance and timelines.
Develops knowledge of US and international regulations and participates in process improvements.
AbbVie discovers and delivers innovative medicines and solutions addressing serious health issues in immunology, oncology, neuroscience, and aesthetics. They are a large global biopharmaceutical company committed to having a remarkable impact on people's lives.
Provide leadership and high-level technical support for research compliance, including reviewing human subjects research submissions and non-research determinations.
Support project teams with data management plans and ensure compliant closeout of learning activities.
Collaborate with the IRBhelp team to ensure timely review and feedback on submissions.
Jhpiego is a nonprofit global health organization affiliated with Johns Hopkins University, focused on improving the health of women and families. With a global presence, it operates in challenging environments across Africa, Asia, and Latin America, emphasizing research compliance and program learning.