[Hiring] Regulatory Submissions Coordinator & Contract Specialist @Medpace, Inc.

Role Description

Our European activities are growing rapidly, and we are currently seeking a full-time, home-based Regulatory Submissions Coordinator & Contract Specialist (Dual role) to join our Clinical Operations team, in Serbia. As a Regulatory Submissions Coordinator & Contract Specialist (Dual role) you will have the opportunity to work within Regulatory Submissions and contract negotiations, supporting our many projects. You will be a productive member of the team and will be mentored and supported as you develop your skills. Working directly with Regulatory Submissions Coordinators and Contract Specialists, you will gain valuable hands-on experience to enable you to develop a career in clinical research.

• Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees in Serbia and Croatia;
• 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;
• Drafting, reviewing, negotiating, and finalizing agreements, termination letters or other legal documents required for a clinical study;
• Identify and assess legal, financial, and operational risks and escalate to appropriate Contract Lead or Contract Manager;
• Provide recommendations and alternative resolutions throughout negotiations using established escalation channels;
• Coordinate with internal functional departments to ensure various site startup activities are aligned with contractual process and mutually agreed up timelines.

Qualifications

• A minimum of a Bachelor's degree is required (preferably in a Life Sciences field or Law);
• 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 local regulatory guidelines and legislation;
• Excellent organizational and prioritization skills;
• Use to work independently with a proactive approach;
• Knowledge of Microsoft Office;
• Fluency in Serbian/ Croatian and English;
• Great attention to detail and excellent oral and written communication skills.

Benefits

• Competitive compensation programs that recognize and reward performance;
• Comprehensive health, wellness, retirement, and PTO benefits;
• Office based culture with occasional WFH that provides flexibility for eligible positions after training;
• Company-sponsored social events;

Company Description

Medpace is a full-service clinical contract research organization (CRO) providing 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 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.