Regulatory Submissions Manager
Medpace
Job Overview
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Job Description
Regulatory Submissions Manager
We are currently seeking a full-time, office-based* Regulatory (Study Start Up) Submissions Manager to join our Clinical Operations team in Melbourne, Australia.
Responsibilities
- Efficiently manage and successfully execute all aspects of global start-up.
- Perform quality checks on submission documents and site essential documents.
- Prepare and approve informed consent forms.
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges.
- 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.
- Regional experience will be highly advantageous.
- Strong oral and written communication skills.
- With 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.
Key skills/competency
- Regulatory Submissions
- Study Start-up
- Clinical Operations
- CRO Experience
- Project Management
- Regulatory Compliance
- Informed Consent Forms
- Global Start-up
- Clinical Research
- Bid Defenses
How to Get Hired at Medpace
- Tailor your resume: Highlight your clinical research and CRO experience, emphasizing global start-up and submission management.
- Craft a strong cover letter: Articulate your understanding of regulatory processes and your proactive problem-solving approach.
- Prepare for interviews: Be ready to discuss specific examples of managing study start-up, document quality, and regulatory challenges.
- Showcase regional expertise: If applicable, emphasize any regional regulatory knowledge you possess, as this is highly advantageous.
- Network with the team: Connect with Medpace employees on LinkedIn to gain insights into their culture and operations.
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