Regulatory Submissions Technical Advisor
il y a 3 semaines
Job Summary:
Our clinical operations activities are growing rapidly and we are currently seeking full-time, Regulatory Submissions Technical Advisor to join our Site Activation and Maintenance team, within Clinical Operations in Leuven, Belgium.
This position plays a key role at Medpace, preparing and reviewing regulatory documents and providing strategic regulatory advice to support clinical trial submissions. Medpace specialises in supporting mid-sized biopharma companies giving you the opportunity to work on complex and challenging trials, often involving new technologies and novel therapies.
If you want an exciting role where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.
Responsibilities:
- Provide regulatory submissions strategic advice and guidance to the Regulatory Submissions Manager (RSM), Medpace project team and Sponsor to ensure submissions compliance with appropriate regulations and requirements;
- Prepare and/or review core trial documents for compliance with relevant guidelines/regulations and for trial suitability;
- Prepare and maintain Part I EU CTR submissions
- Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges;
- Independently interact with Sponsors, regulatory agencies and Medpace colleagues; and
- Present during bid defences, general capabilities meetings and audits, as required.
Qualifications:
- Bachelor’s degree in Life Sciences - Master’s/PhD preferred;
- Significant experience in regional/global regulatory submissions;
- Strong understanding of regulatory documentation, guidelines and legislation;
- Ability to review regulatory guidance and develop proactive solutions to regulatory issues and challenges;
- Experience in reviewing and/or writing core regulatory documents;
- Strong communication, critical thinking and problem-solving skills;
- Ability to independently interact with national/regional regulatory agencies.
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?:
When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.
**Awards**:
- Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
- Recognized by Forbes as one of America's Best Mid-size Companies in 2021
- Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
- Ranked in the top 10 on the 2021 LinkedIn Top Companies list in Cincinnati
**What to Expect Next**:
A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.
- EO/AA Employer M/F/Disability/Vets_
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