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Job Details

Regulatory Affairs Manager - Project Manager

Company: Medpace
Location: Cincinnati
Reference: 2017-3193
Closing Date: 05 Mar 18
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Medpace is a global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas. Our headquarters are located in Cincinnati, Ohio and we are active in over 40 countries across the globe. We continue to steadily grow and are looking to add to our team! Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Affairs Manager to join our Regulatory Affairs team. ...

Requirements:

Medpace is a global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas. Our headquarters are located in Cincinnati, Ohio and we are active in over 40 countries across the globe. We continue to steadily grow and are looking to add to our team!



Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Affairs Manager to join our Regulatory Affairs team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. 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.





* Project management focus to facilitate full global regulatory submissions which will include:
* Tracking, compiling, and maintaining full regulatory applications including initial INDs and NDAs;
* Maintaining timelines for full regulatory submissions;
* Providing regulatory advice and guidance to other Medpace department to ensure compliance with FDA regulations and requirements;
* Interaction with FDA and other regulatory agencies;
* Developing scientific and regulatory briefing documents for pre-IND, end of phase II, and pre-NDA meetings with the FDA; and
* Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges





* Bachelor’s Degree and 7 years regulatory affairs experience, OR Master’s degree and 5 years regulatory affairs experience;
* Experience with FDA and other regulatory agencies is preferred;
* Strong computer skills, project management skills, and a high attention to detail;
* Strong communication skills (both written and oral); and
* Must be a team player with a global regulatory mindset.
* This position may require supervision of junior level staff.



Travel: Less than 10%



WHY MEDPACE?

At Medpace, you will find work that is both challenging and rewarding. At Medpace, you will be given the tools and training to succeed. At Medpace, you will be rewarded for strong performance and provided opportunities to grow professionally.



WHAT TO EXPECT NEXT

We look forward to receiving your application. A member of our recruitment team will review your qualifications. If interested, you will be contacted for an interview.



EO/AA Employer M/F/Disability/Vets

Apply for this job: Regulatory Affairs Manager - Project Manager

Contact Information:

Address:  Medpace, Inc
5375 Medpace Way
Cincinnati
Ohio
45227
USA
Tel:  +1 513 579 9911
Fax:  +1 513 579 0444
Website:  Visit Our Web Site

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