Associate Director, Regulatory Submissions at Medpace, Inc.

South Yarra, Victoria, Australia -

Full Time

Start Date

Immediate

Expiry Date

10 Apr, 26

Salary

0.0

Posted On

10 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Leadership, Regulatory Submissions, Client Relationship Management, Project Management, Continuous Improvement, Communication, Negotiation, Team Orientation, Customer Focus, Presentation Skills, Documentation, Interpersonal Skills, Flexibility, Adaptability, Stress Management, Regional Experience

Industry

Pharmaceutical Manufacturing

Description

We are seeking a key manager to support the Medpace Study Start-up group in APAC Region while being office-based in Melbourne, Australia. This position will be an integral part of the Medpace clinical operations management team. This role will be responsible for the strategic development of the group, and continuous improvement of processes. As a leader of the Study Start-up team you will be responsible for providing input on new business development opportunities and developing and maintaining relationships with clients. You will also be responsible for providing guidance and expertise to the Regulatory Submissions team in terms of competent authority and all applicable submissions. Additional / alternative expertise in other facets of Study Start-up are welcome. Responsibilities Contribute directly to the growth and strategic development of a large, global Study Start-Up team; Develop and identify continuous improvement opportunities of internal processes; Project lead responsibilities: Lead and oversee Study Start-Up/Regulatory Submission activities and timelines to ensure they are in accordance with Medpace standard operating procedures and study protocols; Provide input on new business development opportunities; Develop and maintain relationship with clients; and Support the local Australian team development. Qualifications Bachelor's degree in life sciences or a related field - an advanced degreed is preferred; +10 years of Study Start-Up leadership experience within a CRO or pharmaceutical company; Excellent presentation, negotiation, documentation, leadership, team-orientation, and interpersonal skills; Strong customer focus with ability to manage challenging priorities and remain flexible and adaptive in stressful situations; Excellent written and oral communication skills; and Regional experience *This role offers potential hybrid working arrangements. 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 Associate Director will lead the Study Start-Up team, overseeing regulatory submission activities and ensuring compliance with Medpace standards. They will also contribute to business development and maintain client relationships.