We are currently seeking a full-time, office-based* Regulatory Submissions (Study Start Up) Manager to join our Clinical Operations team in Melbourne, Australia. This is a fantastic opportunity to work in a high-performing team, lead in regulatory strategies and contribute directly to advancing innovative therapies.
Responsibilities
- Efficiently lead and successfully execute all aspects of global project start-up;
- Provide regulatory submissions strategy guidance to Sponsors and develop proactive solutions to start-up challenges
- Prepare and approve informed consent forms;
- Perform quality checks on submission documents and site essential documents;
- Present during bid defenses, general capabilities meetings, and audits.
Qualifications
- More than 5 years of experience in clinical research, preferably with a CRO. In addition to Regulatory experience, experience may include CRA or project management positions;
- Regional APAC experience will be highly advantageous;
- Strong oral and written communication skills.
Note: *role comes with potential hybrid working arrangements.
Medpace Overview
Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV 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 the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.
Why Medpace?
When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.
Purpose-Driven Work
- Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence
Collaborative Culture
- Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
- Leadership throughout Medpace is both accessible and approachable
Continuous Growth & Development
- Office based environment with on-site mentors
- Defined career paths with clear advancement opportunities
- Industry renowned onboarding and training programs designed to accelerate professional development
- Ongoing training and continuous learning opportunities throughout your career
- An environment that encourages employees to influence change, contribute ideas, and grow quickly
Other Employee Benefits
- Competitive compensation programs that recognize and reward performance
- Comprehensive health, wellness, retirement, and PTO benefits
- Office based culture with occasional WFH that provides flexibility for eligible positions after training
- Company-sponsored social events
Please note benefits may vary based on country.
What To Expect Next
A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.
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Regulatory Submissions Lead – Study Start-Up in Melbourne employer: Medpace
Medpace is an exceptional employer, offering a dynamic work environment in Melbourne that fosters professional growth and development within the clinical research field. With a strong focus on employee well-being, competitive compensation, and flexible working arrangements, Medpace supports its team members in achieving their career aspirations while contributing to meaningful advancements in medical therapeutics. Join a globally recognized leader in the CRO industry, where your expertise will be valued and your contributions will make a real impact.
