Medpace
Experienced Regulatory Affairs Specialist
Medpace, Cincinnati, Ohio, United States, 45208
Job Summary:Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based
Regulatory Operations 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 companys 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 :Coordinate all aspects of document-level publishing (e.g., Clinical Study Protocols, Clinical Study Reports, eCTD modules)Assemble electronic regulatory submission packages for US FDA, Health Canada, and other regulatory authorities;Perform peer reviews to ensure document and submission quality;Assist in the design and implementation of new processes or initiatives within the department;Support with the conduct of procedural and software training;Maintain a working knowledge of applicable standard operating procedures (SOPs), regulations, guidance documents, and policies;Participate in and conduct formal interactions with project teams and clients; andOther projects and responsibilities as assigned.Qualifications :
Bachelors Degree in life sciences required;Minimum 3 years experience in management of submissions to regulatory authorities;Advanced working knowledge of eCTD Management software (LORENZ docuBridge), Adobe, ISI toolbox, and Microsoft Office; andSupervisory experience preferred.
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 Us Today.The work weve 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.Cincinnati PerksCincinnati Campus OverviewHybrid work-from-home options (dependent upon position and level)Competitive PTO packages, starting at 20+ daysCompetitive compensation and benefits packageFlexible work scheduleCompany-sponsored employee appreciation eventsEmployee health and wellness initiativesCommunity involvement with local nonprofit organizationsDiscounts on local sports games, fitness gyms and attractionsModern, ecofriendly campus with an on-site fitness centerStructured career paths with opportunities for professional growthDiscounted tuition for UC online programsAwardsNamed a Top Workplace in 2024 by The Cincinnati Enquirer
Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibilityWhat to Expect NextA Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.EO/AA Employer M/F/Disability/Vets
Regulatory Operations 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 companys 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 :Coordinate all aspects of document-level publishing (e.g., Clinical Study Protocols, Clinical Study Reports, eCTD modules)Assemble electronic regulatory submission packages for US FDA, Health Canada, and other regulatory authorities;Perform peer reviews to ensure document and submission quality;Assist in the design and implementation of new processes or initiatives within the department;Support with the conduct of procedural and software training;Maintain a working knowledge of applicable standard operating procedures (SOPs), regulations, guidance documents, and policies;Participate in and conduct formal interactions with project teams and clients; andOther projects and responsibilities as assigned.Qualifications :
Bachelors Degree in life sciences required;Minimum 3 years experience in management of submissions to regulatory authorities;Advanced working knowledge of eCTD Management software (LORENZ docuBridge), Adobe, ISI toolbox, and Microsoft Office; andSupervisory experience preferred.
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 Us Today.The work weve 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.Cincinnati PerksCincinnati Campus OverviewHybrid work-from-home options (dependent upon position and level)Competitive PTO packages, starting at 20+ daysCompetitive compensation and benefits packageFlexible work scheduleCompany-sponsored employee appreciation eventsEmployee health and wellness initiativesCommunity involvement with local nonprofit organizationsDiscounts on local sports games, fitness gyms and attractionsModern, ecofriendly campus with an on-site fitness centerStructured career paths with opportunities for professional growthDiscounted tuition for UC online programsAwardsNamed a Top Workplace in 2024 by The Cincinnati Enquirer
Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibilityWhat to Expect NextA Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.EO/AA Employer M/F/Disability/Vets