[Hiring] Regulatory submissions-Start Up & 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 Latvia;
• 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;
• Used to working independently with a proactive approach;
• Knowledge of Microsoft Office;
• Fluency in Serbian and English;
• Great attention to detail and excellent oral and written communication skills.

Benefits

• Flexible work environment;
• Competitive compensation and benefits package;
• Competitive PTO packages;
• Structured career paths with opportunities for professional growth;
• Company-sponsored employee appreciation events;
• Employee health and wellness initiatives.

Company Description

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.