Hold a leadership role within the study team, overseeing and guiding clinical trial activities at a country or regional level.
Ensure high-quality execution, compliance, and timely delivery while acting as a key coordination point across cross-functional teams.
Focus on leadership, mentorship, and remote oversight of monitoring practices with minimal to no site assignments and a low-travel model.
PSI is a leading Contract Research Organization focusing on delivering quality and on-time clinical trial services across various therapeutic areas. With over 25 years in the industry, it offers a balance of stability and innovation, fostering a dynamic team environment.
Develop and author Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) per EU MDR to support regulatory submissions for CE Mark.
Conduct comprehensive literature searches, review scientific data, and critically appraise literature to support clinical evaluations and risk assessments.
Manage CEP/CER timelines using project management tools and serve as a subject matter expert for R&D and broader Clinical/Medical Affairs activities.
Intuitive is a pioneer and market leader in robotic-assisted surgery, focused on expanding the potential of physicians through minimally invasive care and intelligent technology. The company fosters an inclusive and diverse team of passionate people grounded in integrity, with a strong capacity to learn and the energy to get things done, actively investing in long-term team member growth.
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.
Monitor updates to EP, USP, Mexico Ph, ChP, and JP.
Analyze changes in compendial requirements.
Ensure timely implementation of compendial changes.
Vertex Pharmaceuticals is focused on the discovery, development and commercialization of medicines. They strive to transform the lives of people with serious diseases.