Provide medical direction and oversight for clinical trials, including safety monitoring and medical data review.
Partner with GCO to build client relationships and support proposals, feasibility, and business development.
Serve as drug development SME, contributing to protocols, training, and medical strategy across studies.
Fortrea is a global contract research organization providing clinical development and trial management services to pharma/biotech. It fosters a collaborative, family-like culture focused on advancing life-saving therapies.
Support Clinical Trial Managers with study start-up, protocol development, and Trial Master File preparation.
Coordinate with clinical sites on documentation, training, and compliance with FDA and GCP requirements.
Assist with tracking study payments and providing operational support across the full study lifecycle.
The company is a partner organization specializing in clinical research and development, operating through Jobgether. It offers a structured clinical operations environment with cross-functional teams and professional growth opportunities.
Serve as scientific lead for clinical programs, supporting trial design, execution, data interpretation, and regulatory activities.
Collaborate with cross-functional teams including Clinical Operations, Biostatistics, Regulatory Affairs, and external partners.
Contribute to scientific publications, regulatory submissions, and relationships with investigators and key opinion leaders.
The company is a clinical-stage organization advancing innovative regenerative therapies for significant unmet needs in ophthalmology. It fosters a collaborative, high-performance culture with mentorship and professional growth opportunities.
Lead safety evaluations and benefit-risk assessments for assigned products.
Provide medical leadership for pharmacovigilance activities across development and marketed products.
Support regulatory submissions and health authority interactions, including preparing responses to RFIs.
Alphanumeric is a staffing and recruiting company that places professionals in contract roles with top organizations. This role is a 1-year contract with a major pharmaceutical company, supporting its global Safety Evaluation & Risk Management function.
Lead clinical trial strategies and evidence-generation plans supporting global regulatory submissions.
Design and oversee clinical protocols, claims, and evidence strategies in collaboration with internal and external stakeholders.
Serve as a scientific liaison with regulatory authorities and mentor junior scientists to drive clinical excellence.
The company develops diagnostic products for the US and EU markets, focusing on generating robust clinical evidence for regulatory submissions. It maintains a remote-first culture with a collaborative, cross-functional environment and opportunities for scientific leadership.
Provide direct patient care in telemedicine focusing on obesity and diabetes management, including insulin titration and use of CGMs and insulin pumps.
Collaborate with APPs and dietitians, supervise as needed, and ensure quality care for complex comorbidities like CKD/ESRD and cardiovascular conditions.
Prescribe non-controlled medications, assist in professional development of colleagues, and contribute to team-based care initiatives.
Form Health is a virtual obesity medicine clinic delivering multi-disciplinary evidence-based obesity treatment through telemedicine. Founded in 2019, it is a venture-backed startup with a culture of putting patients first and valuing every employee.
Lead U.S. and global regulatory strategies for oncology biologic development programs.
Prepare and manage Clinical Trial Applications, Marketing Applications, and regulatory amendments.
Collaborate with cross-functional teams to align regulatory plans and manage program risks.
A partner company is seeking a strategic regulatory affairs leader to support innovative oncology biologic and cell/gene therapy development programs. The company offers a fully remote environment with global regulatory exposure and cross-functional collaboration.
Establish and maintain relationships with investigators, sites, and key opinion leaders to support trial execution.
Gather site feedback and translate it into actionable improvements for study teams.
Contribute to protocol development, site selection, and business development activities.
This role is with a partner company that focuses on clinical research and trial execution. The company operates remotely and values collaboration, inclusion, and professional autonomy.
Supports clinical trial design, protocol development, and data interpretation to ensure high-quality data generation.
Provides medical expertise in therapeutic areas, reviews safety data, and contributes to regulatory documents.
Collaborates cross-functionally with clinical operations, regulatory affairs, and other teams to align clinical activities with development plans.
Oruka Therapeutics is developing novel biologics for chronic skin diseases. As a publicly traded biotechnology company with a startup culture, it focuses on offering patients greater freedom from conditions like plaque psoriasis.
Edit and ensure regulatory compliance for pharmaceutical marketing materials across digital and print channels.
Fact-check and proofread copy to adapt for new channels and audiences, providing medical expertise within FDA guidelines.
Collaborate with cross-functional teams and manage multiple projects in a fast-paced environment.
P10 is a creative agency focused on delivering exceptional value for clients. It is a remote-only team of diverse, seasoned professionals driven by passion and purpose.
Lead author on complex regulatory and clinical documents including protocols, CSRs, IBs, and IND/NDA/BLA submissions.
Provide strategic input on document planning, messaging, and quality control while mentoring other writers.
Manage multiple projects independently, balancing timelines and client expectations in a fully remote environment.
Eldridge Writing provides top-tier medical writing services to pharmaceutical and biotechnology clients. We are a small, collaborative team that values quality and serves as a true extension of our clients’ teams.
Conduct clinical audits and risk assessments to identify compliance gaps.
Manage multiple client engagements and deliver accurate project results.
Build strong client relationships and present findings to leadership.
Kodiak Solutions transforms healthcare through technology-driven solutions, specializing in finance, unclaimed property, and risk management. Their innovative platform streamlines operations, allowing providers to focus on patient care.
Provide clinical, scientific, and strategic expertise to drug development programs from lead compound identification to launch.
Lead execution of clinical development plans, including trial documents, regulatory interactions, and cross-functional alignment.
Establish and maintain relationships with external medical experts and represent Ipsen at investigator meetings and scientific conferences.
Ipsen is a mid-sized global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With teams in more than 40 countries, it champions human-centric leadership and fosters a culture of collaboration, excellence and impact.
Provide virtual consultations in menopause and early fertility care, including assessment, diagnosis, and treatment planning using evidence-based guidelines.
Manage metabolic health as a routine part of visits, including prescribing anti-obesity medications such as GLP-1 receptor agonists within clinical protocols.
Maintain multi-state licensure, document visits accurately, and coordinate referrals to ensure comprehensive, timely care.
Carrot is a leading global fertility and family care platform that provides intelligent clinical guidance for fertility, menopause, and family health. The company supports millions of members across 195 countries, has been recognized as a top innovative company by Fast Company and CNBC, and is regularly cited by leading global outlets.
Manage end-to-end IRB meeting workflows, including submissions, reviewer assignments, and meeting preparation.
Facilitate communication among client services, IRB Chairs, Board members, and clients to ensure timely review processes.
Prepare and review informed consent forms for regulatory compliance and quality.
The company coordinates Institutional Review Board (IRB) meetings within a highly regulated clinical research environment. They offer a collaborative and inclusive culture focused on ethical, patient-centered outcomes, though company size is not specified.
Edit and review informed consent forms to ensure regulatory compliance and clarity.
Collaborate with IRB members, sponsors, and sites to incorporate required language.
Mentor junior editors and contribute to process improvements for quality control.
The partner company provides specialized services for clinical research and regulatory compliance. It fosters a collaborative environment and emphasizes ethical research practices, though team size is not specified.
Monitor clinical trial sites to ensure compliance with protocols, SOPs, and regulatory requirements.
Review electronic medical records and source documentation for accuracy and data integrity.
Support site staff and contribute to development of trial materials, SOPs, and training guides.
Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to improve transplant outcomes for blood cancer patients. The company maintains a start-up culture with an entrepreneurial spirit and emphasis on camaraderie.
Develop Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) per EU MDR to support CE Mark submissions.
Interact with cross-functional teams to define strategies for clinical documentation and regulatory submissions.
Conduct literature searches, critically appraise scientific data, and write clinical summaries for products and surgical procedures.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, developing technologies like the da Vinci surgical system and Ion to transform surgery. The company is a team of engineers, clinicians, and innovators united by a purpose to make surgery smarter, safer, and more human, with challenging but deeply meaningful work.
Engage with patients to recruit, educate, and pre-screen them for clinical studies.
Maintain data accuracy across multiple study portals and manage data entry and queries.
Collaborate with site teams and PIs to ensure protocol compliance and resolve issues.
Care Access brings world-class research and health services directly to communities, working to make the future of health better for all. With hundreds of research locations and a global team, we are dedicated to ensuring every person can contribute to medical breakthroughs.
Serve as primary author and lead reviewer for CMC sections of late-stage and commercial regulatory submissions.
Provide hands-on CMC regulatory expertise across global filings, health authority interactions, and post-approval activities.
Collaborate with cross-functional teams to align regulatory strategy with scientific and compliance requirements.
The company is a biotechnology organization developing innovative cell therapies for late-stage and commercial stages. It offers a collaborative, entrepreneurial, and innovative work environment with a fast-paced, senior-level team.