Regulatory Submissions-Start Up & Contract Specialist (Dual Role)

3+ years

Preferred by Comapny

La Jolla Latvia

12 Nov. 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Opportunity: Regulatory Submissions Coordinator & Contract Specialist (Dual Role)

Location: Latvia (Home-based)
Job Requisition ID: 10366
Department: Site Activation & Maintenance

About Medpace

Medpace is a full-service clinical contract research organization (CRO), providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. With over 5,000 employees in 40+ countries, our mission is to accelerate the global development of safe and effective medical therapeutics. Headquartered in Cincinnati, Ohio, we strive to improve the lives of patients worldwide by contributing to medical breakthroughs across all therapeutic areas.

Role Overview

Medpace is seeking a Regulatory Submissions Coordinator & Contract Specialist (Dual Role) based in Latvia. In this home-based position, you will have the opportunity to work in both Regulatory Submissions and Contract Negotiations. This is a unique role that offers hands-on experience and mentorship, while supporting various clinical research projects across Europe. As a member of the Clinical Operations team, you will help develop your career in the clinical research industry.

Key Responsibilities

Regulatory Submissions:
- Prepare, review, and file clinical trial applications with regulatory authorities and Ethics Committeesin Latvia.
- Submit responses to queries and amendments related to clinical trial applications.
- Ensure that all submissions comply with relevant regulations and guidance documents.
- Advise team members on any regulatory changes and compliance requirements.
- Maintain the Clinical Trial Management System and ensure timely document filing.
- Collect essential documents and prepare the essential document packages for drug release.
Contract Management:
- Draft, review, negotiate, and finalize agreements, termination letters, and other legal documents related to clinical studies.
- Identify and assess legal, financial, and operational risks, escalating issues as needed.
- Provide recommendations and alternative solutions during negotiations, using established escalation channels.
- Coordinate with internal functional departments to ensure alignment of site startup activities with contractual timelines.

Qualifications

Education: A minimum of a Bachelor's degree (preferably in Life Sciences or Law).
Experience:
- Experience in preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies.
- Experience in a CRO, pharmaceutical company, or investigative site is preferred.
- Knowledge of local regulatory guidelines and legislation in Latvia.
Skills:
- Organizational and prioritization skills.
- A proactive, independent approach to work.
- Proficiency with Microsoft Office.
- Fluency in Latvian and English.
- Strong attention to detail and excellent oral and written communication skills.

Why Medpace?

Perks & Benefits

Flexible work environment and competitive compensation.
Competitive PTO and benefits packages.
Structured career paths with opportunities for professional growth.
Employee health and wellness initiatives and company-sponsored events.

Recognition & Awards

Forbes: Recognized as one of America’s Most Successful Midsize Companies (2021, 2022, 2023, 2024).
CRO Leadership Awards from Life Science Leader Magazine for expertise, quality, reliability, and capabilities.

How to Apply

To apply for this exciting opportunity, please visit Medpace’s career page and submit your application in English for Job Requisition ID 10366.

Join Medpace and help us make a difference in global healthcare!

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Regulatory Submissions-Start Up & Contract Specialist (Dual Role)

Job Description

Job Opportunity: Regulatory Submissions Coordinator & Contract Specialist (Dual Role)

About Medpace

Role Overview

Key Responsibilities

Qualifications

Why Medpace?

Perks & Benefits

Recognition & Awards

How to Apply

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