| 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 Medical Director NC Open (J#45278) Title: Associate Medical Director Company: Quintiles Job Description The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas. In fact, Quintiles conducts more clinical trials than anyone else in the world. Become involved in work that improves the quality of life for people around the globe. Let your career soar! We are seeking an enthusiastic Associate Director/Medical Director/Senior Medial Director, Rheumatologist, General Medicine to join our team! The Rheumatologist will provide medical, clinical, and scientific advisory expertise to all Quintiles divisions as requested. Incumbent will participate in all aspects of Medical and Scientific Services' involvement on assigned trials. Assists in the implementation of department mission, goals and objectives, oversight of operations, development of policies and procedures and standards for the department. RESPONSIBILITIES - Serves as Regional Medical Advisor and/or Global Medical Advisor on assigned projects. - Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility. - Performs review and clarification of trial-related Adverse Events (AEs). - Performs medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narratives. - Provides medical support for the Analysis Of Similar Events (AOSE). - Performs medical review of Adverse Event coding. - Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs). - Performs medical review of the Clinical Study Report (CSR) and patient narratives. - Available 24 hours per day, 7 days per week, to respond to urgent protocol-related issues at the investigative sites. - Attends and presents at the Investigator Meeting(s). - Provides therapeutic area/indication training for the project clinical team. - Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested. - Serves as Scientific Advisor and provides guidance to Project Managers on the medical and scientific aspects of assigned projects. - Provides support to the proposal development team which may include, but is not limited to, reviewing the protocol for feasibility, giving guidance as to anticipated enrollment, and general advice as to the various risks associated with running a particular study. - Participates in the development of Medical & Scientific Services portion of client proposals including the budgeting - process. - Serves as a resource, and may participate in strategic business development activities including presentations to prospective clients, professional meetings, and other business development activities for Medical & Scientific Services. - Budget responsibility for large global multi-million dollar programs; responsible for all safety issues on these programs. - Provides expert consultation to NovaQuest, the Partnering Group of Quintiles Transnational, and supports the due diligence research of select compounds and/or companies as requested. - Serves as Regional Medical Director and/or Global Therapeutic Head for larger teams and/or regions. - Participates in management level meetings within Medical & Scientific Services. - Supervises Medical and Scientific Services Staff with assigned direct reports and provides mentoring as required. - Ensures that departmental goals, objectives, policies, and procedures are communicated, understood, and implemented by assigned staff. - Recommends course of action on management/human resources matters, including salary administration, transfers, - hiring, terminations, professional development, performance appraisals, and employee counseling. - Identifies ongoing training and development needs of assigned staff. - Evaluates assigned staff workload and creates volume projections in order to ensure appropriate balance of project - assignments for direct reports. - Maintains awareness of industry developments and participates in professional meetings, and may author related - publications. - Performs special projects as requested by management. 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. | |||