| RegulatoryCareers.com | |||
| Jobs Index - Index of recent job listings. | |||
| Resumes Index - Index of recently posted resumes. | |||
| RegulatoryCareers.com - Register here for more Regulatory Affairs Services Jobs | |||
| |||
| Associate Director IL Open (J#39805) Title: Associate Director Company: Baxter Job Description: Review and assist with development of investigator initiated studies.Take ownership of trial clinical research results and critically evaluates Investigator Initiated Studies (IIS) proposals. This includes responding to adverse effects surfaced by internal or external quality reviews, determining if corrective action is required as well as directing, managing and ensuring corrective actions are applied successfully.Experience with clinical trials needed as well as sound grounding in Biostatistics and Regulatory Affairs to support the Therapeutic Area Leader activities, as needed, in clinical development including label changes, evaluation of product complaints and adverse events in conjunction with these specialty functions.Assist in the review of advertising/promotional material by providing clinical and ethical perspective input; serve as the medical affairs signatory.Develop and maintain strong scientific and medical relationships with KOLs around the globe along with developing the educational and informational priorities for the therapeutic area.Provide leadership with respect to the maintenance and enhancement of the clinical and technical Medical Information team by keeping abreast of the current trends through the published medical literature, scientific meetings, and establishing professional relationships with external clinicians and business partners.Act as Medical Monitor for clinical research studies. Capable of developing communications plan, including publication plans for therapeutic area.Provide expertise related to the evaluation and reporting issues and adverse events in conjunction with pharmacovigilance, as directed by the Therapeutic Area Leader. Including the review of all adverse clinical consequences or complaints that could have led to an adverse clinical consequence and determine if corrective actions are necessary.Demonstrate an understanding of the clinical use of the product lines within the IV solutions sub-business. More... | |||
| RegulatoryCareers.com - Register here for more Regulatory Affairs Services Jobs | |||
| RegulatoryCareers.com is the premier job search website focused specifically on the employment needs of Regulatory Affairs Companies and Professionals. Use this as an exclusive resource to find your next job or employee. We guarantee that you will be pleased with the special focus of this web site. | |||