About the role
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.
Responsibilities
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 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 Serbian/ Croatian 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) providing phase l-lV 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.
Why Medpace?
When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.
Purpose-Driven Work
Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence
Collaborative Culture
Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
Leadership throughout Medpace is both accessible and approachable
Continuous Growth & Development
Office based environment with on-site mentors
Defined career paths with clear advancement opportunities
Industry renowned onboarding and training programs designed to accelerate professional development
Ongoing training and continuous learning opportunities throughout your career
An environment that encourages employees to influence change, contribute ideas, and grow quickly
Other Employee 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
Please note benefits may vary based on country.
What to Expect Next
A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.
Originally posted on Himalayas