Clinical Trial Application (CTA) Coordinator

ProPharma • Raleigh, NC

2d • Remote

About The Position

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio of regulatory sciences, clinical research solutions, life science consulting, R&D technology, pharmacovigilance, and medical information services to help solve complex challenges in a dynamic regulatory environment. With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.

Responsibilities

• Interaction with the cross-functional team (client and CRO) to ensure optimal execution of the regulatory strategy.
• Liaising with the CRO and provide oversight to the CTA submissions and query management.
• Providing regulatory expertise to questions raised by the cross-functional team when preparing for the CTA submissions.
• Ensuring regulatory submission packages and RA correspondences are archived in the internal systems.
• Reviewing CTA packages prior to submission and provide Regulatory greenlight for submission.
• Reviewing CTA documentation (Protocol, ICFs, IMPD, etc.) and provide Regulatory feedback Project Assumptions/Scope Limitations.

What This Job Offers

• Job Type: Full-time
• Education Level: No Education Listed