Responsible for providing support with regard to all aspects of Clinical Pharmacology including study planning, Pharmacokinetic (PK) analysis, and reporting for early and late stage clinical development plans in accordance to appropriate regulatory guidelines. Work with the regulatory team, project managers, data managers, biostatisticians, and other clinical research specialists to ensure accurate execution of research protocols in agreement with good scientific and clinical research practices, and in compliance with Noven standard operating procedures (SOPs) and other company procedures. Review methodologies and data collection, perform analyses, interpret findings, and write reports for submission to the U.S. Food and Drug Administration (FDA).
Assignment to the various levels is approved by Corporate Compensation and is based on the required knowledge in the field of work, years of experience, on-going responsibility for highly complex assignments, significance of the scope of responsibility, and the job function's considerable impact within the department and the company, as well as the reporting relationship and required supervisory responsibility.
Education & Experience:
Majority of time spent in office environment, operating computer.
Visual acuity and manual dexterity required to operate computer and proofread documents.
Noven is an equal opportunity and affirmative action employer which recruits, hires, trains and promotes persons in all positions without regard to race, color, religion, sex, national origin, citizenship, disability, or veteran status or any other legally protected status.