Support operational execution of cell therapy clinical trials with a focus on vendor management and central laboratory oversight.
Ensure vendors deliver high-quality, timely services aligned with study timelines, budgets, and regulatory requirements.
Oversee site feasibility, selection, contracting, start-up, and close-out activities to support study milestones and program objectives.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by core values of collaboration, clarity, innovation, and ownership, the team is committed to transforming the future of treatment for autoimmune disease.
Identify and manage changes to medical rules by reviewing policies, transmittals, and bulletins for revision, retirement, or addition.
Build and maintain Clinical Transaction Engine tables, assign CPT/HCPCS codes, and review national policies for integration into medical edits.
Independently prepare data editorials for production release, analyze coding trends, and resolve client issues forwarded by Compliance Support.
Experian is a global data and technology company that powers opportunities for people and businesses by redefining lending, preventing fraud, simplifying healthcare, and creating digital marketing solutions. With over 23,300 employees across 32 countries, it's a FTSE 100 company known for its innovative, people-first culture focused on inclusion and development.
Support maintenance and execution of global publication plans and manage end-to-end activities for manuscripts, abstracts, and posters.
Support planning and execution of key scientific congresses and medical meetings, including logistics coordination and vendor management.
Ensure compliance with internal policies and external publication guidelines while proactively communicating with publication leads and external authors.
Kyverna Therapeutics is a biotech company developing therapies for autoimmune diseases. The company operates in a fast-paced clinical environment with a focus on cross-functional collaboration in medical affairs.
Develop and translate economic evidence into value-based messaging for payer and formulary decision makers.
Build and drive the US value proposition story for approved and pipeline cancer therapies, incorporating health economic impact.
Direct strategy for formulary submission packages, economic models, and provide pharmacoeconomic expertise to cross-functional teams.
Iovance Biotherapeutics is a biotechnology company pioneering tumor infiltrating lymphocyte (TIL) therapy for treating cancer. The company operates in a dynamic, innovative environment focused on cell therapy development and commercialization.
Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting for over 35 trials per year.
Serve as the internal project manager for assigned oncology disease groups, providing timely updates on submission status and regulatory guidance on study development.
Act as the liaison between sponsors, investigators, Winship, Emory IRBs, external IRBs, and internal departments, ensuring all facets of each protocol are compliant.
Emory University is a leading research university that fosters excellence and attracts world-class talent. Winship Cancer Institute of Emory University is Georgia's only National Cancer Institute-designated Comprehensive Cancer Center dedicated to discovering cures for cancer and providing innovative therapies and clinical trials.
Lead and execute internal audits across GMP, GCP, and GPV systems.
Conduct GxP audits in accordance with applicable regulatory requirements.
Oversee the GxP vendor and supplier management program.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, we are committed to transforming the future of treatment for autoimmune disease.
Support regulatory operations for SaMD products across development, submission, launch, and post-market phases
Coordinate preparation, compilation, publishing, and archival of regulatory submissions and related correspondence
Maintain regulatory documentation, including: submission trackers, product registrations/listings, regulatory commitments, approvals and clearance records, and change assessment logs
Oura's mission is to empower every person to own their inner potential. Their award-winning products help their global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. As a quickly growing company focused on helping people live healthier and happier lives, they ensure that their team members have what they need to do their best work — both in and out of the office.
Develop an efficient and effective Usability program consistent with international regulatory requirements and FDA guidance.
Lead the construction and execution of both formative and summative usability activities for SaMD applications
Generate Regulatory Submission content for Usability Engineering, including Plans, Reports, Use Error Analysis and Traceability
Radformation is transforming the way cancer clinics deliver care. Their innovative software automates and standardizes radiation oncology workflows. They are a fully remote, mission-driven team united by a shared goal to reduce cancer’s global impact and help save lives.
Support regulatory strategy and submission timelines for US market
Own quality oversight of supplier relationships for US market
Lead CAPA investigations and effectiveness verification
Optain is a healthcare company using software and hardware to rethink care. They aim to improve the way we detect and manage eye and systemic conditions and have a close-knit and highly talented team.
Participate in Ro’s cross-functional advertising review process, evaluating creative assets for FDA advertising and promotion compliance.
Serve as an internal subject matter expert on FDA advertising and promotion requirements.
Stay abreast of changes in FDA regulations and industry trends in health product advertising.
Ro is a direct-to-patient healthcare company with a mission of helping patients achieve their health goals by delivering the easiest, most effective care possible. Ro is the only company to offer nationwide telehealth, labs, and pharmacy services and is consistently recognized as a top workplace.