Manage site start up through activation readiness strategy and oversight of site start up delivery.
Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations and Contract Execution.
Collaborate and communicate with stakeholders to secure input for milestone planning and alignment of operational goals.
Precision for Medicine is a Clinical Research Organization with an integrated offering that enables precision medicine by combining clinical trial designs, experts, biomarker and data analytics solutions. They focus on rare diseases and oncology, in addition to other therapeutic areas.
Collaborate with client teams to understand products and create regulatory strategies.
Implement strategies by engaging regulatory authorities and authoring submissions.
Proactively influence the regulatory environment to achieve business goals.
EVERSANA provides next-generation commercialization services to the life sciences industry, serving over 650 clients from biotech startups to established pharmaceutical companies. They have a global team of more than 7,000 employees committed to creating a healthier world by bringing innovative therapies to market and supporting patients.
Maintain knowledge of regulations applicable to submissions for medical devices.
Communicate technical and scientific information to project teams and regulatory authorities.
Collaborate with cross functional teams to develop regulatory strategy.
Cook Research Inc. manufactures medical devices and is part of the Cook Group companies. They are committed to equal employment opportunities and value diversity within their workforce.