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Posted: Tuesday, September 5, 2017 8:34 PM

SUMMARYExperienced 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.DESCRIPTION OF JOB DUTIESOversee 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); andOversee compliant archiving of all regulatory documents with permissions in place for accessQUALIFICATIONS/REQUIREMENTSAdvanced 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); andPassionate about growing a strong and productive global regulatory operations organizationWHY 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 NEXTWe 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


• Location: Cincinnati

• Post ID: 49326572 cincinnati is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2017