Senior Specialist – Study Start Up, Regulatory Affairs

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🔥 0 minutes ago

🌐 Serbia, Poland – Remote

🇷🇸 Serbia – Remote 🇵🇱 Poland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 15%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Lead and coordinate activities required to achieve site initiation readiness • Provide subject matter expertise and ensure regulatory compliance • Liaise with internal teams, clients, and external stakeholders • Deliver assigned study start-up and regulatory milestones within defined scope • Make independent decisions regarding regulatory processes and documentation approaches • Lead study start-up and regulatory activities for assigned countries or medium-complexity projects • Prepare, review, and quality-control regulatory and study start-up documentation, including submissions, essential documents, and translations • Draft, negotiate, finalize, and execute clinical site agreements, ancillary agreements, and amendments at country or regional level • Review labels, patient information sheets, diary cards, insurance documents, and related materials for ICH-GCP and country-specific compliance • Contribute to preparation and review of complex technical, scientific, and legal documentation • Arrange and/or review translations of essential documents • Provide regulatory and Study Start-Up strategic input to internal and external customers • Develop regulatory strategy, Study Start-Up plans, joint operating procedures, and core documents • Identify and escalate project risks and support corrective/preventive actions • Perform other assigned work-related duties

🎯 Requirements

• Graduate degree in Chemistry or Life Sciences, Nursing, or equivalent combination of education and experience • Minimum 4 years within the pharmaceutical or CRO industry or a regulatory body • Good knowledge of ICH GCP and national regulations for territories of competency • Good understanding of specific country requirements pertaining to Study Start-Up/Regulatory delivery in multiple countries within Europe and/or the Americas • Experience or knowledge relevant to regulatory processes, study start-up, and clinical research documentation • Ability to handle medium-complexity regulatory environments, including multi-country requirements • Knowledge of regulatory and study start-up documentation, submissions, essential documents, and translations • Knowledge of clinical site agreements and ancillary agreements • Knowledge of labels, patient information sheets, diary cards, and insurance documentation • Knowledge of technical, scientific, and legal documentation • Knowledge of regulatory strategy, Study Start-Up plans, joint operating procedures, and core documents

🏖️ Benefits

• Collaborative, international team • Career growth opportunities • Flexible work arrangements / remote work • Work-life balance • Opportunity to work with colleagues across North America, South America, Europe, Asia and Australia • Purpose-driven work helping bring safe and effective pharmaceutical treatment to patients • Passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting