Job Requirements:
- 1- 3 years in a related area including manufacturing, regulatory affairs, quality in the pharmaceutical, medical device, or other healthcare industry
- Demonstrated analytical capabilities.
- Experience/understanding/use of software tools.
- Bachelor's degree preferred in a science, manufacturing or quality discipline.
Job Description:
- Responsible for reviewing & maintaining registration compliance information in accordance with change control processes.
- Work with US, ex-US & CMC areas to establish data categorization and provide analysis of data in system.
- Receive and enter registration compliance data into system. review data & determine if new categories/classifications are required.
- Responsible for maintaining keyword lists associated with the data entry requirements.
- Work with global regulatory affairs area representatives & affiliates to build relationship and common understanding of the requirements for Registration Compliance. Assimilate disparate information from multiple resources, analyze for trends, adjust and raw inferences.
- Track metrics associates with data capture/entry effort. Execute business processes for Registration Compliance.
Company Description
inVentiv Health Clinical is seeking to fill this position on behalf of a client company. inVentiv Health Clinical, LLC, an inVentiv Health, Inc. company, is an Equal Opportunity Employer, M/F/Disabled/Vets that values the strength that diversity brings to the workplace. inVentiv Health Clinical is a global CRO and leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies, offering therapeutically specialized capabilities for Phase I-IV clinical development, bio analytical services, and strategic resourcing from a single clinical professional to an entire functional team. With approximately 7,000 passionate employees in more than 36 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world. inVentiv Health Clinical is part of inVentiv Health, a best-in-class team of global healthcare experts offering clinical, commercial and consulting services designed to provide a comprehensive customer experience that delivers greater long term value. We offer exciting career paths for clinical research professionals, including permanent and contract opportunities.
Work location: Chicago, IL