Regulatory submissions-Start Up & Contract Specialist (dual role) at Medpace, Inc.

, Georgia, United States -

Full Time

Start Date

Immediate

Expiry Date

09 Jul, 26

Salary

0.0

Posted On

10 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory submissions, Contract negotiation, Clinical trial applications, Ethics committee submissions, Regulatory compliance, Clinical trial management system, Legal document drafting, Risk assessment, Clinical research, Microsoft Office, Communication skills, Organizational skills, Prioritization, Proactive approach, Attention to detail

Industry

Pharmaceutical Manufacturing

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 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. 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. 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 Georgian and English; and Great attention to detail and excellent oral and written communication skills. We kindly ask to submit applications in English. Medpace Overview 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. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks 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 Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Responsibilities

The role involves preparing and filing clinical trial applications with regulatory authorities and ethics committees while ensuring compliance with local regulations. Additionally, the specialist will draft, review, and negotiate legal agreements and manage site startup activities for clinical studies.