Regulatory submissions-Start Up & Contract Specialist (dual role)

Medpace, Inc.

9h•Remote

About The Position

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 the country of Georgia. 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. Please note that this role is not US based and you must be located in the country of Georgia to be considered.

Requirements

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 Georgian and English; and
Great attention to detail and excellent oral and written communication skills.

Responsibilities

Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees in Georgia;
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 assesses 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.