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.
Lead pharmacovigilance strategy and operations across the portfolio, ensuring regulatory compliance and safety oversight.
Oversee outsourced PV vendors, build quality systems, and manage safety data exchange agreements.
Partner cross-functionally with Clinical Development, Regulatory, and Quality to advance pipeline from early to late-stage development.
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. It is a lean organization with a build-oriented culture, advancing a pipeline from Phase 1 to Phase 3.
Lead global pharmacovigilance audits, regulatory inspections, and readiness planning.
Oversee issue management, deviations, root-cause analysis, and CAPA activities.
Develop and manage the global pharmacovigilance training program and procedural documentation.
Our partner is a fast-growing biopharmaceutical company focused on improving outcomes for patients with severe autoimmune diseases. It offers a collaborative environment with opportunities for professional growth and leadership development.
Lead the PV Medical Writing function, ensuring high-quality, compliant, and timely deliverables.
Manage and develop the PV Medical Writing team, fostering performance, engagement, and professional growth.
Drive quality, compliance, inspection readiness, and continuous improvement initiatives, including oversight of SOPs, KPIs, audits, and regulatory inspections.
PrimeVigilance is a global pharmacovigilance specialist helping clients navigate complex regulations while keeping patient safety at the center of every decision. With teams across Europe, North America, South America, Asia and Australia, we foster a culture of kindness, flexibility, growth, and belonging.
Help implement and maintain new features within the Veeva Safety suite.
Work closely with customer business and IT staff to understand and design solutions.
Guide customers in adopting Vault and industry best practices for post-implementation success.
Veeva Systems is a mission-driven pioneer in industry cloud, helping life sciences companies accelerate therapies to patients. As a fast-growing SaaS company surpassing $3B in revenue, it operates as a public benefit corporation balancing customer, employee, society, and investor interests.
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.
Lead global regulatory strategy for assigned programs, overseeing processes and managing risks to achieve successful registration and lifecycle management.
Collaborate cross-functionally with teams including toxicology, pharmacology, and clinical development to support clinical programs and regulatory submissions.
Serve as point of contact with health authorities, interpret regulatory guidelines, and drive innovative approaches to regulatory sciences.
Recursion is a clinical-stage TechBio company that uses AI and technology to decode biology and accelerate drug discovery and development. The company employs hundreds across multiple global offices and values integrity, collaboration, and bold action.
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.