Coordinates various aspects of research study, including preparation or necessary documents, patient recruitment, enrollment and follow-up. Organization of study visits, scheduling and communication with investigational pharmacy and laboratories.
Performing screening assessments including physical examinations, medical history review; reviews results of diagnostics studies, evaluates subjects with regard to suitability for clinical research studies
Independently perform sample testing, data processing, data report and data interpretation for biosimilar development and stability studies, CQA assessment, similarity assessment and forced degradation.
Responsible for identifying major red flags on new product development and capital estimations, identifying opportunities and providing recommendations on which opportunities are or are not feasible, and taking the necessary actions to course correct and refine, or create a case on why the ideas should be pursued or rejected.
This position has responsibilities for a wide variety of Pharmacovigilance activities for different drug development programs. Responsibilities include the coordination and monitoring of all stages of adverse event processing, tracking, review, evaluation, reconciliation and reporting in cooperation with our clients' global organization and third party CROs involved in remote/outsourced activities.
The applicant will be required to have strong technical expertise in high throughput multi-parameter cellular platforms including flow cytometry and high content imaging to enable phospho, cytokine, CFSE, MLR and immune cell coculture assay readouts.
The SS is responsible for collecting all safety data relevant to the issue to be evaluated. The execution of this task is typically a joint effort between the Global Safety Lead (GSL) and the SS for medically complex topics.
In this role, you will perform a wide variety of moderately and highly complex tasks and analysis of human fluids and tissues, using manual procedures as well as operating various laboratory equipment and automated analyzer systems.
Develop in vitro assays for evaluating mechanisms of drug resistance, drug differentiation and pharmacodynamic marker identification (develop resistant cell lines, make stable knock-downs and knock-ins, cellular trafficking studies)
In this role, the selected candidate will conduct technical analysis and provide oral & written feedback (as email, brief documents, slides) within a pharmaceutical regulatory submissions business context.