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Regulatory Submissions Specialist

2 months ago

Bristol, Maine, United States Medpace Full time
Job Overview:

As our clinical operations expand, we are looking for a dedicated full-time Regulatory Submissions Specialist to become a vital part of our Clinical Operations team. This role involves collaborating with a team to execute essential tasks and projects that contribute significantly to the organization's achievements. If you are seeking a rewarding career where you can leverage your existing skills while also advancing your professional development, this position is tailored for you.

Key Responsibilities:
  • Prepare, review, and submit clinical trial applications to both domestic and international regulatory bodies;
  • Ensure that all submissions adhere to relevant regulations and guidance documents;
  • Provide counsel to sponsors regarding evolving regulations and compliance standards;
  • Monitor submissions and guarantee the punctual filing of necessary documents.
Required Qualifications:
  • Bachelor's degree in life sciences;
  • A minimum of 1 year of experience with IND submissions to regulatory agencies;
  • Exceptional organizational and communication abilities;
  • Proficiency in Microsoft Office;
  • Practical experience in preparing, reviewing, and submitting regulatory documentation.

Travel Requirements: Minimal

About Medpace:

Medpace is a comprehensive clinical contract research organization (CRO) that offers Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device sectors. Our mission is to expedite the global development of safe and effective medical therapies through a scientific and methodical approach. We utilize local regulatory and therapeutic expertise across various major areas, including oncology, cardiology, metabolic diseases, endocrinology, central nervous system disorders, as well as anti-viral and anti-infective treatments. With our headquarters in Cincinnati, Ohio, we employ over 5,000 professionals across more than 40 countries.

Why Choose Medpace?

Joining Medpace means becoming part of a team committed to supporting the development of innovative drugs and devices. Our employees bring hope to individuals affected by serious health conditions. We invite you to contribute to a mission that positively impacts millions globally while enjoying a competitive compensation package and opportunities for internal advancement.

Awards and Recognition:

  • Medpace has been consistently recognized as a Top Workplace in Cincinnati by the Cincinnati Enquirer;
  • Named one of America's Best Mid-size Companies by Forbes in 2021;
  • Ranked among the top CROs for site ratings across all essential attributes, including CRA training, preparation & organization, staff accessibility, open communication, and timely drug availability;
  • Regularly acknowledged with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.

Next Steps:

A member of our recruitment team will evaluate your qualifications, and if your profile aligns with our needs, you will be contacted for an interview.

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Important Notice: Please be cautious of phishing scams that offer job opportunities with Medpace in exchange for money. Scammers may impersonate legitimate employees. A Medpace employee will never request a credit card, send a check, or ask for any form of payment as part of the hiring process. All applications must be submitted online, followed by an interview process.