Senior Director Pharmaceutical Science-CMC

At Cardinal Health, we’re developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities.

 

Senior Director Pharmacy Science:Manages all  Chemistry, Manufacturing, and Control (CMC)-related activities associated with product development for pharmaceuticals, biologics, and medical devices, including strategic development, evaluation of scientific information, and regulatory and scientific document preparation and maintenance.Establishes CMC-focused product development plans, including scientific and regulatory strategies, project outlines and timelines.Provides regulatory guidance and assistance to meet the diverse needs of clientsInteracts directly with clients and contractors as required by projects, including participation in teleconferences and various types of meetings on behalf of clients; is instrumental in identification, selection, and management of Contract Research Organization activities on behalf of clients.Provides appropriate reviews of regulatory documents, as required.Interacts with regulatory authorities, including providing liaison, preparation for, and attendance at formal FDA meetings.Prepares responses (written and verbal) to clients in a timely manner regarding scientific and regulatory problems, issues, concerns, questions, and strategies associated with the drug- development processParticipates, as appropriate, in client training programs (e.g., the “U.S. Pharmaceutical Development and Regulatory Systems Workshop”)Attends, as appropriate, related professional meetings and workshops in order to maintain knowledge of current trends in the pharmaceutical industry to further the professional status of the BAI organization.Trains, as necessary, new associates in managing and performing work related to clientsSupervise staff and direct administrative operations, as required, to ensure smooth and efficient project work flowTo perform the job successfully, the individual must be able to satisfactorily perform the duties listed above.The requirements listed below are representative of knowledge, skill, and/or ability required.Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.To perform the job successfully, the individual must be able to satisfactorily perform the duties listed above.The requirements listed below are representative of knowledge, skill, and/or ability required.Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.