Senior Regulatory Specialist (New York)

Insight Global is seeking a Senior Regulatory Specialist to support pre-activation initiatives for a leading healthcare client in New York. This person will be responsible for programmatic support to initiate clinical trials. Reporting directly to the Senior Manager of Regulatory Affairs Unit, they will serve as the internal project manager for the specific oncology disease group(s) for which they are assigned and provide the group timely updates on the status of submissions and regulatory guidance on study development. Additionally, they will serve as the liaison between the sponsor, CRO, IRB, FDA, and internal departments. The ideal candidate is proactive, organized, and a strong communicator.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity / affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and / or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal. com.

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Master's degree in Public Health Administration

3+ years of oncology research experience

Extensive knowledge of oncology clinical trials and oncology terminology; knowledge of government codes and regulations

Proficiency in Microsoft Office

Excellent verbal communication and presentation skills

Bachelor's degree