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CMC Subject Matter Expert - Regulatory Affairs Job in Cincinnati, Ohio US
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Job Summary

Company
Medpace, Inc.
Location
Cincinnati, OH
Industries
Government and Military
Job Type
Full Time
Employee
Years of Experience
1+ to 2 Years
Job Reference Code
40513997_3

CMC Subject Matter Expert - Regulatory Affairs

About the Job

CMC Subject Matter Expert – Regulatory Affairs



Job Locations

United States-OH-Cincinnati






Category


Regulatory Affairs



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 approximately 3,500 people across almost 40 countries.



Job Summary





Our corporate activities are growing rapidly, and we are currently seeking full-time, office-based Chemistry, Manufacturing, and Control (CMC) subject matter expert to join our Cincinnati office. This person will work on a Regulatory Affairs (RA) project team to accomplish tasks and projects that are instrumental to the company’s success. With this opportunity, you will be able to leverage previous expertise and continue to develop and grow your career even further within the drug development industry.



Responsibilities






Responsibility and accountability for the development and execution of global CMC strategy in support of clinical trial activities and RA project team goals across multiple projects;

Lead the preparation, development, and review of CMC documentation including Investigational Medicinal Product Dossiers (IMPDs), Module 3 documents, and Quality Overall Summaries, as well as the CMC sections of other regulatory documents, including scientific advice briefing documents and Investigator’s Brochures;
Act as the CMC point-of-contact within the RA project team, Medpace, and with Sponsors to provide end-to-end support and guidance within the contracted scope of the project;
Maintain up-to-date knowledge and understanding of global regulatory CMC requirements, guidance, conventions, and technologies;
Maintain timelines for CMC components of regulatory deliverables;
Ensure all CMC documents and deliverables are completed within the agreed upon timelines and developed with full compliance to all regulatory guidance, internal review and quality control processes; and
Support RA project teams and Sponsors in response to Regulatory Authority CMC queries and participate in meetings and teleconferences with Regulatory Agencies as needed. Ensure submissions comply with applicable regulations and guidance documents



Qualifications





Masters or PhD preferred;
At least 2 years of prior experience in the research or pharmaceutical industry;
Working knowledge of CMC development strategy;
Experience in preparation of CMC documents (IMPDs and Module 3) in support of global regulatory filings;
Demonstrated experience managing CMC project deliverables, scope, and timeline
Strong computer skills, project management skills, and a high level of attention to detail;
Demonstrated strong communication (both written and oral) and interpersonal skills to positively influence internal and external teams; and
Ability to work independently with little to no guidance as well as demonstrate ability to act as a team player.

Travel: None



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
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

What to Expect Next:

A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.

*WARNING: Please beware of phishing scams that offer opportunities with Medpace in exchange for sending money.  These scammers pose as legitimate employees from actual companies.  Please be advised that a Medpace employee will never ask you for a credit card, send you a check, or ask you for any type of payment as part of consideration for a role with our company. All of our careers require that you first complete an online application and go through some sort of interview process.

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