Sweden – Telecommute
Experienced Regulatory Submissions Coordinator
Sweden-Home based | Sweden-Home based
Category Clinical Operations
Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach. We leverage local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 2,700 people across 36 countries.
Our clinical operations activities are growing rapidly and we are currently seeking a full-time, home-based Regulatory Submissions Coordinator to join our Nordic Clinical Operations team. This position plays a key role in the start-up and management of clinical trials at Medpace. If you want an exciting career in a global environment where you will work closely with internal teams and personal at the research site, where you will be to able to develop and grow your career, then this is the opportunity for you.
Provide day-to-day departmental support activities to Regulatory Submissions Coordinators;
Interact with Nordic research site for preparation of clinical trial documents.
Write and update clinical trial documents
Collect, review, organize, and assemble regulatory start-up submissions to regulatory authorities, ethics committees and local committees for the Nordic countries as needed
Maintain database and spreadsheets as necessary to facilitate tracking and documentation of departmental activities;
Translate and review minor translations
Maintain and perform quality checks of the Trial Master File; and,
Perform other tasks as needed.
A 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 Sweden;
Excellent organizational and prioritization skills;
Use to work independently with a proactive approach
Knowledge of Microsoft Office;
Fluency in English and local language; and
Great attention to detail and excellent oral and written communication skills.
Candidates can be based anywhere within Sweden
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.
Medpace Named a Top Cincinnati Workplace for 2015, 2016, 2017 and 2018 by the Cincinnati Enquirer
Winner of the ACRP-Avoca CRO Quality Award in 2018
Recognized with six CRO Leadership Awards from Life Science Leader magazine
Eagle Award winner – which recognizes outstanding leadership, professionalism, integrity, and dedication to advancing the clinical research profession through strong site partnerships
What to Expect Next
We look forward to receiving your application. A member of our recruitment team will review your qualifications and if interested, you will be contacted for an interview.
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*WARNING: Please beware of phishing scams that offer opportunities with Medpace in exchange for sending money…
Medical & Health , Medical Research