Job Summary :
Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Manager to join our Site Activation & Maintenance team in soon to be opened office in Osaka, Japan. This position plays a key role in the clinical trial management process at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.
We offer the following：
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Customized training program;
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Hybrid work style and adaptable working hours;
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Annual company bonus;
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Annual merit salary increases;
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Defined Contribution Plan;
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Group term life insurance;
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Insurance association benefits available;
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Clear pathways for career growth, with opportunities to step into leadership roles;
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Collaboration with a diverse, international team and gain global exposure;
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Many additional perks unmatched by other CROs!
Responsibilities :
- Efficiently manage and successfully execute all aspects of global project start-up;
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Perform quality checks on submission documents and site essential documents;
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Prepare and approve informed consent forms;
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Review pertinent regulations to develop proactive solutions to start-up issues and challenges;
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Present during bid defenses, general capabilities meetings, and audits.
Qualifications :
- Bachelor’s degree or Master's/PhD degree within Life Sciences and more than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
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Strong oral and written communication skills.
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Knowledge of pharmaceutical industry, International Conference on Harmonization guidelines, and FDA or applicable local regulations.
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Possess thorough understanding of regulatory submissions activities;
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Demonstrated ability to organize, instruct and supervise a team in the completion of multiple tasks/projects;
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Native level Japanese (JLPT N1) is standard, a minimum English TOEIC score of 500 or equivalent.
Travel: Minimal
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
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Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence
Collaborative Culture
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Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
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Leadership throughout Medpace is both accessible and approachable
Continuous Growth & Development
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Office based environment with on-site mentors
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Defined career paths with clear advancement opportunities
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Industry renowned onboarding and training programs designed to accelerate professional development
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Ongoing training and continuous learning opportunities throughout your career
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An environment that encourages employees to influence change, contribute ideas, and grow quickly
Other Employee Benefits
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Competitive compensation programs that recognize and reward performance
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Comprehensive health, wellness, retirement, and PTO benefits
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Office based culture with occasional WFH that provides flexibility for eligible positions after training
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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.
