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Regulatory Operations Manager (Sign-On Bonus Eligible) 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
Less than 1 Year
Job Reference Code
48757075_1

Regulatory Operations Manager (Sign-On Bonus Eligible)

About the Job

Regulatory Operations Manager (Sign-On Bonus Eligible)



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





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.

Offering sign-on bonus up to $20k based on experience.



Responsibilities





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
Oversee compliant archiving of all regulatory documents with permissions in place for access
Prepare and/or oversee the preparation of high-quality regulatory submissions for multiple programs/products in development (e.g. IND, NDA, BLA) with a focus on eCTD
Manage the review of regulatory submission documents for completeness and quality in accordance with regulatory agency requirements and standards
Manage projects with vendors and contractors to meet schedules and ensure quality
Serve as the Regulatory Operations lead, collaborating with Regulatory Affairs, Medical Writing, and the cross-functional project team to develop and implement submission strategies and timelines
Provide functional and technical guidance with respect to submission of clinical trial applications and marketing applications
Manage and maintain regulatory information including relevant logs, trackers and archives of regulatory submissions, correspondence and commitments.
Develop and provide training on the use of regulatory templates, processes and tools critical to compiling electronic submissions (i.e., software, authoring templates and publishing tools)



Qualifications





Advanced degree in a related field;
At least 5 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?





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
Recognized by Forbes as one of America's Best Mid-size Companies in 2021
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.

EO/AA Employer M/F/Disability/Vets
 

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