Lead risk management and safety data review for assigned products, ensuring regulatory compliance.
Provide safety-related content for clinical and regulatory documents, and prepare for inspections.
Mentor a small pharmacovigilance team while driving end-to-end operational oversight.
Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies for blood cancer patients. We maintain a start-up culture of camaraderie and leadership by example, with a small dedicated team.
Provide regulatory strategy and guidance across the clinical development lifecycle, including submissions to Regulatory Authorities and Ethics Committees.
Coordinate and prepare regulatory documents such as CTA/IND, annual reports, amendments, orphan designations, and marketing applications.
Represent Global Regulatory Affairs at project team meetings, lead submission projects, and mentor Regulatory Affairs Specialists.
Precision for Medicine is a CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences, focusing on Oncology and Rare Disease. They are a growing global team that values employee contributions and fosters an environment where ideas are valued and nurtured.
Develop and lead integrated global regulatory strategies for I&I pipeline programs.
Serve as primary regulatory strategist and Health Authority relationship lead.
Provide expert guidance on development plan design and filing strategies.
Beeline Medicines is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases. It is a small company backed by world-class investors, with a culture of scientific rigor and operational excellence.
Lead product safety surveillance strategies and risk management for investigational products.
Oversee medical review of safety data and ensure compliance with global pharmacovigilance regulations.
Build pharmacovigilance infrastructure and manage vendor partnerships as the company grows.
Oruka Therapeutics develops novel biologics for chronic skin diseases like plaque psoriasis. It is a growing biotechnology company with a startup culture focused on making a difference.
Lead medium- to high-complexity clinical trials with full accountability for timelines, budgets, resources, and quality.
Oversee financial performance, risk mitigation, and quality standards while ensuring regulatory compliance.
Mentor Project Leaders and represent project leadership in client meetings, bid activities, and conferences.
A clinical research organization managing complex clinical trials and therapies. It fosters a fast-paced, collaborative environment focused on innovation, accountability, and professional development.
Oversee regional project management, ensuring high-quality delivery and compliance with global standards.
Manage financial aspects including project margin, profitability, and reporting.
Lead and develop project management team, including training and line management.
Brandtech+ is a global creative production company specializing in film, CGI, automation, AI, motion design, and digital/print content. They partner with over 300 clients in 40+ countries and are part of The Brandtech Group, focusing on innovation and high-quality solutions.
Support the development and execution of clinical regulatory strategies for assigned programs across regions.
Prepare and manage IND applications and other regulatory submissions, ensuring accuracy and timely delivery.
Provide regulatory guidance to cross-functional teams and participate in health authority interactions.
Zai Lab is an innovative, research-based biopharmaceutical company based in China and the US, focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients worldwide. Founded in 2014, Zai Lab has a global team of approximately 2000 employees and is committed to gender diversity and environmental responsibility.
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.
Serve as primary point-of-contact liaison with clients, providing outstanding customer service and participating in proposal activities and client presentations.
Oversee all aspects of clinical research trials, directing project managers and ensuring consistency across assigned portfolios.
Manage study budgets, financial health, and project plans, including risk management and quality assurance, while leading cross-functional teams.
Precision Medicine Group is a people-focused CRO that combines novel clinical trial designs, industry-leading operational and medical authorities, and advanced biomarker and data analytics solutions, with a passion for rare diseases and oncology. The company fosters a supportive and collaborative environment, promoting work-life balance and team development, with a growing team dedicated to ground-breaking cancer therapies.
Define and lead global regulatory strategy for clinical-stage radiopharmaceutical programs.
Lead key regulatory submissions including INDs, CTAs, and DMFs.
Serve as primary contact for regulatory agencies and build strong relationships with health authorities.
ARTBIO discovers and develops a new class of Alpha Radioligand Therapies (ARTs) to redefine cancer care. It is a global biotech with offices in Boston, Basel, London, and Oslo, fostering a collaborative and supportive culture.
Creates and executes the study TMF Plan and ensures team understanding of expectations.
Monitors and reports on TMF Health to internal team and sponsor, identifying trends and risks.
Serves as point of contact for audits and inspections, and supports process improvement initiatives.
Precision for Medicine is a clinical research organization that provides services for drug development, including trial management and regulatory compliance. The company fosters a collaborative environment with a focus on quality and innovation.
Responsible for site activation readiness, submission preparation, and interaction with Competent Authorities and Ethics Committees.
Manage essential document collection, informed consent customization, and maintain project plans and trackers.
Partner with cross-functional teams and act as subject matter expert for country-specific regulatory knowledge.
We are a global life sciences company specializing in clinical trial regulatory and start-up services. We are expanding our capabilities across Latin America and seek experienced professionals to join our team.
Oversee study start-up, site activation, and close-out activities while managing study plans and essential documents.
Collaborate with cross-functional teams, sponsors, and vendors to ensure timely and compliant project execution.
Mentor CTA team members and contribute to TMF quality, inspection readiness, and regulatory compliance.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. They are a collaborative community committed to making a meaningful impact on global health, valuing team members and empowering them.
Develop and execute regional construction strategies to align with global goals, ensuring projects meet timelines, budgets, and quality standards.
Lead and manage a multidisciplinary team of construction, design, and supply chain professionals to drive high performance and continuous improvement.
Oversee vendor and contractor relationships, supply base development, and stakeholder communication to maintain positive partnerships and regulatory compliance.
NTT Global Data Centers is a leading provider of AI-ready data centers, operating over 150 facilities across more than 20 countries globally. They foster a collaborative, innovative, and inclusive workplace where employee growth is supported and ideas are valued.
Serve as the primary point of contact for assigned protocols, linking Country Operations with the clinical trial team.
Manage project timelines, deliverables, and performance for clinical studies from feasibility to close out.
Ensure compliance with ICH/GCP, country regulations, and company policies while leading local study teams.
Merck is a global healthcare leader with a diverse range of prescription medicines, vaccines, and animal health products. With over 100 years of history, the company employs tens of thousands worldwide and fosters a culture of innovation and inclusivity.
Lead and mentor a project management team ensuring compliance with best practices and successful delivery of projects.
Manage workflow, resource allocation, and finance tracking to ensure project profitability and timely delivery.
Support customer escalation, line management, and drive AI initiatives to improve processes.
Brandtech+ is a global team specializing in film, CGI, automation, AI, motion design, and digital/print content. They partner with over 300 clients in 40+ countries and focus on connecting clients with high-quality solutions and talent.
Serve as primary point-of-contact and escalation point for clients, coordinating functional services and vendors to meet quality, scope, cost, and time objectives.
Manage study budget and financial health, ensuring projects remain within scope and identifying out-of-scope activities, while overseeing billing and forecasting.
Develop robust project plans with timelines and risk management, ensure quality management including eTMF inspection readiness, and lead internal and client meetings.
Precision for Medicine is a CRO that integrates clinical trial execution with scientific expertise and data sciences to accelerate life-changing therapies, focusing on Oncology and Rare Disease. It is a growing organization that values employee contributions and fosters a collaborative culture.