Principal Scientist, Regulatory Science and Strategy

Principal Scientist, Regulatory Science and Strategy 

Job Overview

Provide scientific and regulatory leadership to guide and make recommendations to key life sciences customers for their clinical development and post-market programs. Additionally, lead the development of the regulatory science and strategy practice by defining and developing offerings. 

As a Principal Scientist, you will interface internally and externally to promote the science and strategy practice, lead the development of business opportunities and delivery of client projects. You will also serve as a product owner for new offerings, working with clients and internal stakeholders to understand market needs, develop requirements, and support sales and future evolution of new offerings.

Examples of envisioned regulatory offerings: Real World Regulatory Intelligence and Real-World Evidence for Label Expansion.

Essential Functions

•    Lead the regulatory science activities for the practice. Ensure team has robust processes to monitor the external regulatory environment and identify new/emerging trends.
•    Coordinate scientific activities across Regulatory science and strategy offerings. Perform research, benchmarking, and comparative analyses to nurture innovation. Review new regulations to building an understanding of evolving regulatory landscape.

•    Serve as a regulatory and scientific point of contact. Provide regulatory and global scientific oversight for our clients.
•    Lead project activities related to scientific research including regulatory insight generation, regulatory requirement interpretation, and lead analogue research.
•    Lead projects from conceptualization to delivery to the client. 

•    Participate in annual performance review team processes.
•    Engage in recruitment and selection of new staff.
•    Mentor, coach, and share subject matter expertise with others to help develop individuals and capabilities delivering world-class solutions for clients.

•    Scientific and Regulatory ownership as a subject-matter expert (SME) for business development activities like requests for information (RFIs) and requests for proposals (RFPs).
•    Prepare scientific material including white papers. Develop training documents for internal and external consumption.

Qualifications

•    A strong academic track record including a Masters (PhD/MD preferred) in relevant field.
•    At least 12 years professional experience in life sciences advisory, consulting, and/or medical product industries. 
•    Experience of working with and at FDA preferred.
•    Minimum of 4 years of experience focused on regulatory science along with the use of real-world data and real-world evidence across the product lifecycle, including study design.
•    Experience working on client engagements with management and delivery responsibility.
•    Demonstrable experience in and commitment to the life sciences and/or healthcare sectors.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.