Senior Scientist — Regulatory Cardiac Safety/Electrophysiology (Scientist II)

The Senior Scientist ensures study design; execution and reporting align with regulatory and client project specifications. The Senior Scientist provides critical client consultation throughout study life cycle and ensures lab compliance to study design. This role will support Electrophysiology projects including cardiac safety screening in a GLP-compliant electrophysiology lab and serve as a Principal Investigator for regulated studies. This role requires technical expertise, portfolio leadership, leadership competencies, and proficiency in client communication within a contract research organization.Senior Scientist — Regulatory Cardiac Safety/Electrophysiology (Scientist II) responsibilities include, but are not limited to, the following:The Senior Scientist is a scientific leadership position, responsible for providing guidance and alignment between our customer base, the industry at large, commercial teams and service operations. This role is a hands-on laboratory-based role and will be collaborative and influential in a broad network of business functions in support of delivering high quality services to our valued customers, and driving business growth, brand recognition, and alignment with Eurofins core competencies. This position will train and mentor junior staff, responsible to take informed decision to move projects ahead, set direction, champion change and directly contribute to achieving departments goals and strategies.Develops client and stakeholder relationships through technical leadership and collaborationManages client projects in all phases of study life cycle from study design to reportingProvides guidance and oversight for compliance and scientific integrity of the studies to ensure that studies are performed in a compliant mannerUnderstands and follows all procedures and processes required for work performed under Regulatory Compliance (i.e. GxP, FDA/GLP and GCP, OECD, CLIA, etc.) and completes annual GLP trainingDirects investigations of service operations, such as deviation reports, non-conforming reports, corrective action reports, etc. Produces documentation according to established standardsDrafts and approves operations documents to assure consistency with regulatory standards and requirements. (I.e. SOPs, batch records, training records, etc.)Responsible for data generation, review, analysis review and ensuring accuracy and integrity of reportingProvides scientific guidance that supports technical writing and final review of Validation Plans and Reports as requiredSupports client services team in generating proposals, RFPs, study plans and scope of work preparation. Assists pricing team in completing custom pricing and cost analysisCompletes required training and supports 100% of Employee Health and Safety requirementsManages responsible use of confidential IT and business systems, as requiredEnsures accurate data management and reporting, with the highest integrity, and manages quality control on project data and reportsAccountable for delivering to unit and site key performance metrics (quality, delivery on time)Supports site goals and demonstrates Eurofins' competencies, as defined in the job planProvides training to colleagues and external end users, when requiredPerforms other duties, as assigned