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

				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.

Responsibilities:

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

We kindly ask to submit applications in English.
			

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