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Job Details

Director, Regulatory Operations

Company: Medpace
Location: Cincinnati
Reference: 2016-1752
Closing Date: 05 Mar 18
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Experienced Regulatory Operations professional with experience in complete pharmaceutical development life cycle management. Expert in global eCTD publishing for all project initiation through marketing application submissions, including post-approval. Strong leadership, clear vision, able to motivate and create nimble high performing teams. Experienced manager of Regulatory Operations staff and processes with a focus on delivery with excellence while maintaining quality and compliance.

Requirements:

Experienced Regulatory Operations professional with experience in complete pharmaceutical development life cycle management. Expert in global eCTD publishing for all project initiation through marketing application submissions, including post-approval. Strong leadership, clear vision, able to motivate and create nimble high performing teams. Experienced manager of Regulatory Operations staff and processes with a focus on delivery with excellence while maintaining quality and compliance.



* Oversee global publishing and submission process for domestic and international regulatory bodies;
* Manage the process from inception to approval;
* Utilize systems and tools for electronic document capture, generation, manipulation, scanning and QC;
* Coordinate and supervise development/implementation of technology and processes to manage timely and effective publishing and document management, meeting emerging global requirements;
* Oversee maintenance of all technologies and infrastructure needed to facilitate transactions with Sponsors, within Medpace departments, and with regulatory agencies globally;
* Coordinate validation of all electronic Regulatory operations systems (Part 11 compliance); and
* Oversee compliant archiving of all regulatory documents with permissions in place for access



* Advanced degree in a related field;
* At least 8 years of global drug development and regulatory operations/affairs experience in the CRO, Biotechnology or Pharmaceutical industries;
* Proven leadership and program management experience;
* Creative thinker, motivational leader, strong manager;
* Strong team member and collaborative team player;
* Strong computer skills, project management skills, and a high attention to detail;
* Strong communication skills (both written and oral); and
* Passionate about growing a strong and productive global regulatory operations organization

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.

AWARDS

Medpace is being recognized locally, nationally, and globally for their work in the industry as well as the culture they have developed for their team.

* Medpace Named a Top Cincinnati Workplace for 2015, 2016 and 2017 by the Cincinnati Enquirer
* Medpace named Top Ten CRO in 2015 CenterWatch Investigative Site Survey
* Eagle Award winner and nominee – which recognizes outstanding leadership, professionalism, integrity, and dedication to advancing the clinical research profession through strong site partnerships.

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

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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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