Executive Director of US Regulatory Strategy
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing approximately 3,500 people across almost 40 countries.
Our clinical activities are growing rapidly, and we are currently seeking a full-time, Executive Director of US Regulatory Strategy
to join our team. This position is accountable for the development and implementation of the regulatory strategy for specific Sponsor projects, for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the team. The RAD possesses strategic leadership skills, has deep experience in North American (US and Canada) regulatory science and overall drug/biologic development processes and strategies. Experience and knowledge of therapeutic areas and drug development is an important enabler to being able to influence cross-functional discussions Sponsors and relevant stakeholders.
- Provide senior level, experienced regulatory leadership to satisfy expected industry standards, applying in-depth knowledge of regulatory requirements and guidelines, procedures and agency precedent.
- Advises project teams regarding the development and implementation of regulatory strategy through the clinical and nonclinical development processes.
- Lead and support regulatory and broader development teams on strategic projects including gap analyses, meetings with regulatory authorities, protocol synopsis development and review, and other strategic deliverables.
- Provide regulatory advice and guidance to Clinical Operations, Medical Writing, Clinical Safety/Pharmacovigilance, Data Management, and Biostatistics.
- Maintain advanced knowledge of changing regulatory requirements and advise teams as appropriate.
- Interact with appropriate national/regional government regulatory agencies; and
- Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.
- Advanced life science degree
- 10+ years of regulatory affairs experience in a CRO or Pharmaceutical industry
When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.
- Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
- Recognized by Forbes as one of America’s Best Mid-size Companies in 2021
- Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next:
A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.
EO/AA Employer M/F/Disability/Vets
*WARNING: Please beware of phishing scams that offer opportunities with Medpace in exchange for sending money. These scammers pose as legitimate employees from actual companies. Please be advised that a Medpace employee will never ask you for a credit card, send you a check, or ask you for any type of payment as part of consideration for a role with our company.
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Job posted: 2021-11-07