Regulatory Submissions Coordinator (Study Start Up)
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Job SummaryOur clinical operations activities are growing rapidly, and we are currently seeking an experienced Regulatory Submissions Coordinator to join our Clinical Operations team in the UK. This position plays a key role in the clinical trial management process at Medpace.
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. Please note that this is an office-based position in LondonResponsibilitiesPrepare, review, and file initial clinical trial applications to regulatory authorities;Prepare and submit responses to queries and amendments to clinical trial applications;Ensure submissions comply with applicable regulations and guidance documents;Advise team members on changing regulations and compliance requirements;Maintain the Clinical Trial Management System and ensure timely filing of documents;Collection of essential documents and preparation essential documents packages for drug release.
QualificationsA minimum of a Bachelor's degree is required (preferably in a Life Sciences field);Experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries;Relevant working experience at a CRO, Pharmaceutical Company, or an investigative site;Knowledge of regulatory guidelines in the UK;Excellent organizational and prioritization skills;Use to work independently with a proactive approach;Knowledge of Microsoft Office;Great attention to detail and excellent oral and written communication skills.
Medpace OverviewMedpace is a full-service clinical contract research organization (CRO) providing phase l-lV 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 the advancement of clinical research.
We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.
Why Medpace? When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.
Purpose-Driven WorkWork alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellenceCollaborative CultureContribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
Leadership throughout Medpace is both accessible and approachableContinuous Growth & DevelopmentOffice based environment with on-site mentorsDefined career paths with clear advancement opportunitiesIndustry renowned onboarding and training programs designed to accelerate professional developmentOngoing training and continuous learning opportunities throughout your careerAn environment that encourages employees to influence change, contribute ideas, and grow quicklyOther Employee BenefitsCompetitive compensation programs that recognize and reward performanceComprehensive health, wellness, retirement, and PTO benefitsOffice based culture with occasional WFH that provides flexibility for eligible positions after trainingCompany-sponsored social events Please note benefits may vary based on country.
What to Expect NextA Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted. Job SummaryCategory: Site Activation & Maintenance