A Regulatory Submissions Technical Advisor is a professional who provides guidance and expertise on the technical aspects of submitting regulatory documents - Hoffman, MN, United States - Phoenix Industries

Phoenix Industries

Verified Company

Hoffman, MN, United States

2 days ago

Posted by:

James Miller

beBee Recruiter

Freelance

Description

Hoffman, MN Job Summary:

Our clinical operations are rapidly expanding and we are currently seeking full-time, Regulatory Submissions Technical Advisors to join our Site Activation and Maintenance team within Clinical Operations.

In this role at Medpace, you will play a crucial part in preparing and reviewing regulatory documents and providing strategic regulatory advice to support clinical trial submissions.

Medpace specializes in supporting mid-sized biopharmaceutical companies, giving you the opportunity to work on complex and challenging trials, often involving new technologies and novel therapies.

If you are looking for an exciting position where you can utilize your previous expertise and continue to grow your career, then this is the perfect opportunity for you.

Responsibilities:

Provide strategic regulatory advice and guidance to the Regulatory Submissions Manager (RSM), Medpace project team, and Sponsor to ensure compliance with appropriate regulations and requirements for submissions.
Prepare and/or review core trial documents to ensure compliance with relevant guidelines and regulations and suitability for the trial.
Prepare and maintain Part I EU CTR submissions.
Review relevant regulations and guidance to develop proactive solutions for regulatory issues and challenges.
Independently interact with Sponsors, regulatory agencies, and Medpace colleagues.
Participate in bid defenses, general capabilities meetings, and audits as needed.

Qualifications: