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Senior/Vice President of Technical Affairs in Clinical ...

PAREXEL - Columbus, OH

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Job Description

At Parexel, we don't just support drug development—we help shape it. As a Senior/Vice President of Technical Affairs on our Regulatory Strategy (RS) team, you'll be at the forefront of innovation, guiding biopharma companies through complex regulatory landscapes to bring safer, more effective therapies to patients worldwide. In this dynamic role, you will: Lead strategic regulatory initiatives across diverse product types and global markets Advise clients throughout the product lifecycle, from early development to post-marketing Share your scientific, technical, and commercial expertise to influence regulatory outcomes Collaborate with and lead teams of respected subject matter experts Represent Parexel as a visible thought leader in the industry Embrace new situations and demonstrate your innate curiosity and passion for science, the industry, and public health. If you are committed to improving public health and making a meaningful difference, this is the perfect opportunity for you. We are currently seeking a highly experienced Clinical Regulatory Leader with expertise in clinical trial design and drug development to join Parexel's renowned Regulatory Strategy team! A successful candidate must be an internationally recognized professional with proven rainmaking skills and relationships at senior levels within client organizations. You will have a comprehensive understanding of our consulting models and methodologies, along with extensive knowledge of the services provided by RS. You will also mentor and guide other RS employees, contributing to the development of new service offerings and methodologies. Key Responsibilities: Project Execution: Work collaboratively or independently based on project needs. Lead issue resolution, prioritize workloads, and capitalize on opportunities to improve project efficiency and results. Thought Leadership: Present at industry seminars, author articles, and contribute to professional organizations as an expert in your field. Consulting Activities and Relationship Management: Provide technical and business consulting, serve as a trusted advisor, and develop solutions tailored to client needs. Requirements: Education: MD required. Experience: 15+ years in Clinical Development/Clinical Trial Design with significant regulatory knowledge. Previous experience with a regulatory agency (such as the FDA or MHRA) is essential. Extensive experience in Endocrinology, Neuroscience, Rare Disease, or Immunology. Willingness to travel up to 20-30% domestically and internationally for client meetings and conferences. #LI-LB1 #LI-REMOTE Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status.

Created: 2026-03-04

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