Experienced Regulatory Publishing Associate

Job Summary:

Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Publishing Associate to join our Regulatory Affairs team in Cincinnati. 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.

Responsibilities :

• Publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable electronic publishing standards;
• Implement publishing processes across multiple complex regulatory documents;
• Perform document quality control checks for others in the department, promptly communicating irregularities in documents and coordinating issue resolution;
• Provide day-to-day department support activities as necessary to aide completion of documents, including Clinical Study Reports, Report Appendices, Protocols, etc.;
• Support management with the conduct of procedural and software training
• Develop understanding and maintain knowledge of appropriate standard operating procedures (SOPs), regulations, policies, and regulatory guidance documents; and
• May be responsible for other projects and responsibilities as assigned

Qualifications :

• Bachelor’s Degree;
• 2-3 years experience in management of submissions to regulatory authorities;
• Experience in eCTD Management software; GlobalSubmit, Adobe and ISI toolbox experience preferred;
• Demonstrates a high attention to detail;
• Ability to successfully train under the more advanced Specialists on how to perform all aspects of the job;
• Strong communication skills and ability to work with a diverse group of people.

Medpace 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 more than 5,000 people across 40+ countries.

Why Medpace?:

People. Purpose. Passion. Make a Difference Tomorrow. Join Today

 

The work we’ve done over the past 30 years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

 

Medpace Celebrates 30 Years

As we celebrate 3 decades of industry expertise and organic growth, we recognize the global team responsible for driving clinical development at Medpace. Click here to learn more about Medpace Celebrating 30 Years.

Cincinnati Perks

• Cincinnati Campus Overview
• Hybrid work-from-home options (dependent upon position and level)
• Competitive PTO packages, starting at 20+ days
• Flexible work hours
• Discounted tuition for UC online programs
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives
• Community involvement with local nonprofit organizations
• Competitive compensation and benefits package
• Structured career paths with opportunities for professional growth
• Partnership and discount with onsite childcare
• Discounts on local sports games, local fitness gyms and attractions
  • Official Sponsor of FC Cincinnati
• Modern, ecofriendly campus with an on-site fitness center, bar, and restaurants

 

Awards:

• Recognized by Forbes as one of America's Best Mid-size Companies in 2021 and 2022
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

 

What to Expect Next:

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

 

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