Regulatory Submissions (Study Start-up) Manager at Medpace, Inc.

Seoul, , South Korea -

Full Time

Start Date

Immediate

Expiry Date

10 Apr, 26

Salary

0.0

Posted On

10 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Submissions, Clinical Research, Project Management, Communication Skills, Scientific Technical Knowledge, Problem Solving, Regulatory Background, APAC Experience

Industry

Pharmaceutical Manufacturing

Description

We are currently seeking a full-time Regulatoy (Study Start Up) Submissions Manager to join our Clinical Operations team in Seoul, South Korea. Responsibilities Experience with direct communication with MFDS, liaising between the local authorities and Sponsors to solve queries and expedite local approvals; Regional experience efficiently managing and successfully executing all aspects of regional start-up in APAC region; Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and Present during bid defenses, general capabilities meetings, and audits. Qualifications More than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience; Possess Regulatory background/ strong scientific technical knowledge Regional experience will be highly advantageous; Excellent English oral and written communication skills. Travel: Minimal Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Responsibilities

The Regulatory Submissions Manager will communicate directly with MFDS and manage regional start-up processes in the APAC region. They will also review regulations to develop solutions for start-up challenges and present during various meetings.