Manage regulatory submissions and site activation readiness across the UK.
Negotiate budgets and contracts with sites and vendors.
Coordinate with ethics committees and competent authorities for approvals.
Precision for Medicine is a global Clinical Research Organization that combines novel clinical trial designs, operational and medical experts, advanced biomarker and data analytics, and a passion for rare diseases and oncology. The company values growth and innovation, fostering a collaborative and inclusive environment.
Oversee operational preparation and execution of regulatory submissions, ensuring technical compliance and timely delivery.
Manage routine submissions like INDs, CTAs, and health authority responses, while supporting complex filings and maintaining submission plans.
Compile, publish, and validate eCTD packages, coordinate submission delivery, and maintain accurate records in Veeva RIM.
A partner company of Jobgether, a pharmaceutical and biotechnology organization focused on developing innovative oncology therapies. The company values regulatory precision and operational efficiency across global programs, with a remote-first culture.
Provide medical oversight for clinical trials, safeguarding participant safety and ensuring protocol compliance.
Review adverse events and safety data, contributing to regulatory reporting and clinical documentation.
Collaborate with investigators and clinical teams to support study design, execution, and risk management.
This position is listed on behalf of a partner company that manages all applications and next steps. The role supports global clinical research in a remote working environment with cross-functional collaboration.
Perform scientific document quality control and source verification for clinical, nonclinical, CMC, and regulatory documents.
Organize and maintain documentation in SharePoint, Veeva, and other systems while reconciling records and supporting migrations.
Coordinate document review cycles, prepare packages for submissions and inspections, and support cross-functional documentation needs.
Alterity Therapeutics is a late-stage clinical biotechnology company focused on developing disease-modifying treatments for rare and debilitating neurodegenerative disorders. They operate with a cross-functional team that prioritizes regulatory and quality excellence to support clinical development.
Collaborate with project teams to support study startup and serve as primary point of contact for clinical sites.
Provide training on Beacon's devices and protocols, monitor progress, and maintain GCP/ICH compliance.
Address operational issues via Zendesk and Asana and deliver actionable site feedback for workflow improvements.
Beacon Biosignals is transforming precision medicine for the brain with at-home EEG and cardiopulmonary monitoring platforms for clinical development and diagnostics. They foster a remote-first culture with hubs in Boston, New York, and Paris, emphasizing curiosity, simplicity, and empathy.
Prepare and submit clinical trial applications to Competent Authorities and Ethics Committees, ensuring compliance with local and international regulations.
Manage essential documents, informed consent forms, and site activation readiness, mitigating risks to timelines.
Act as subject matter expert and mentor for site start-up activities, maintaining regulatory intelligence and audit readiness.
Precision Medicine Group provides clinical trial services, including regulatory and site start-up support. The company is expanding across Latin America and values expertise, collaboration, and compliance.
Partner with cross-functional teams and study sites to support clinical operations across all trial phases.
Perform remote monitoring of clinical trials and serve as secondary contact for sites supporting CRAs.
Ensure proper reporting and follow-up of SAEs, address non-compliance issues, and assist with audit/inspection readiness.
Premier Research is a global clinical research, product development, and consulting company helping biotech, specialty pharma, and MedTech innovators turn breakthroughs into new treatments. The company fosters a collaborative culture focused on agility, continuous learning, and making an impact.
Coordinate clinical trial site activities and support successful site start-up and activation.
Serve as a primary point of contact for investigative sites, facilitating communication among clinical teams, sponsors, CROs, and regulatory stakeholders.
Ensure compliance with ICH/GCP guidelines, manage essential documentation, regulatory submissions, and site activation milestones.
This role is listed on behalf of a partner company in the clinical research sector, focused on coordinating site start-up and activation for clinical trials. The culture emphasizes operational excellence, collaboration, and patient safety, with a remote working environment.
Prepare and publish regulatory submissions including eCTD packages for IND, CTA, and Health Authority responses.
Maintain submission plans, follow up on document readiness, and perform document- and submission-level technical QC.
Support Veeva RIM records, promotional submissions (Form FDA 2253), and submission-related projects.
Summit Therapeutics is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs. Its global team is driven by core values of integrity, collaboration, and purposeful urgency, with multiple Phase 3 clinical studies in oncology.
Lead regulatory operations across the portfolio and build/manage the Regulatory Information Management System.
Drive submission planning and execution for regulatory submissions, including DSURs, IBs, and marketing applications.
Establish efficient processes for regulatory records, document management, publishing, and health authority correspondence.
Erasca is a clinical-stage precision oncology company focused on discovering, developing, and commercializing medicines for patients with cancer. The company fosters a casual, collaborative, and entrepreneurial culture in a small or mid-sized biotech environment.
Provide compliance documentation and knowledge management support to the Contracts Management and Compliance Division.
Maintain the organization-wide risk register, track mitigation actions, and support sub-recipient due diligence workflows.
Coordinate compliance training, monitor U.S. government regulatory updates, and prepare compliance reports for leadership.
Jhpiego is a global health nonprofit affiliated with Johns Hopkins University, dedicated to improving the health of women and families in developing countries. The organization values diversity, equity, and inclusion, and offers a supportive, mission-driven work culture.
Lead clinical research project planning, execution, and delivery, ensuring regulatory compliance and quality.
Coordinate cross-functional teams and manage timelines, budgets, and study documentation.
Serve as the primary sponsor and client contact, providing regular project updates and resolving issues.
Alimentiv is a global CRO advancing therapies for gastrointestinal diseases, with deep expertise in IBD drug development. With about 700 employees across multiple countries, it is a private, profit-with-purpose company focused on scientific research and its people.
Lead preparation of state authorization applications, renewals, annual reports, and related filings.
Research and monitor state regulatory requirements affecting academic programs and distance education.
Develop and maintain compliance calendars, tracking systems, and documentation repositories.
Saybrook University is a non-profit, regionally accredited university known for humanistic studies and rigorous research. It offers advanced degrees in psychology, counseling, and organizational systems, and fosters a diverse and inclusive community.
Monitor clinical investigative sites to ensure protocol execution and regulatory compliance.
Conduct site qualification, initiation, interim monitoring, and closeout visits for Phase 1-4 studies.
Train site personnel, manage investigator payments, and identify new investigators and sites.
AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, and neuroscience. It is a global biopharmaceutical company committed to integrity, innovation, and transforming lives.
Independently manage assigned clinical trial activities in compliance with GCP and regulations.
Oversee essential study documentation, TMF completeness, and study trackers.
Manage vendors, CTMS activities, and cross-functional coordination to ensure compliant study execution.
Cognito Therapeutics is a neurotechnology company developing a new therapeutic approach to cognitive and neurological health, including an investigational therapy for Alzheimer's disease. The company is an interdisciplinary team united by a shared purpose of protecting and progressing the human ability to think, learn and remember.
Lead the planning, authoring, and delivery of regulatory documents for global development programs, health authority interactions, and marketing applications.
Develop strategic document plans and author complex submissions such as INDs, CTAs, IBs, CSRs, and briefing packages while ensuring ICH/GCP compliance.
Coordinate cross-functional teams, manage external vendors, mentor junior writers, and drive process improvements to maintain submission readiness.
The company is a biopharmaceutical organization focused on developing innovative therapies for patients with significant unmet medical needs. It operates as a remote, cross-functional team with a culture emphasizing regulatory excellence, collaboration, and career development.
Contribute to regulatory strategies and coordinate interactions with health authorities.
Manage preparation and submission of INDs/CTAs, BLAs, annual reports, and safety reports.
Collaborate with cross-functional teams to ensure GXP compliance and support regulatory inspections.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases. It leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells, with a culture driven by scientists and industry veterans.
Oversee delegated audits related to UM, Credentialing, Claims, Enrollment, and Appeals processes to ensure compliance with payer contracts.
Educate staff, update policies and workflows, and act as a liaison between payers and local market leadership during audits.
Operationalize regulatory communications from governing bodies and document process changes for upstream and downstream teams.
Dignity Health Management Services offers integrated management and business services to healthcare providers, focusing on managed care administrative and clinical services to contain costs and improve quality. It is part of CommonSpirit Health, a large health system with a mission-driven culture centered on community and patient care.
Monitor clinical studies at investigative sites to ensure compliance with protocols, SOPs, and ICH-GCP.
Coordinate study setup and initiation activities, including investigator identification and regulatory submissions.
Identify study risks and propose mitigation strategies while maintaining high quality and detail.
Precision for Medicine is a CRO integrating clinical trial execution with scientific expertise and data sciences, focusing on Oncology and Rare Disease. It offers a supportive, small-CRO culture with high CRA retention and emphasis on work-life balance.
Lead Loyal's overall regulatory strategy across CMC and clinical activities, from early development through post-approval lifecycle management.
Act as the primary liaison with global regulatory agencies and own approval submission strategy and execution.
Build and scale a high-performing regulatory organization, establishing governance frameworks and eCTD publishing capabilities.
Loyal is a clinical stage veterinary medicine company developing longevity drugs for dogs. It is a well-funded startup led by a first gen female CEO, with a culture focused on innovation, transparency, and empathy for all life.