Specialist, Study Start Up – Regulatory Affairs

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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

• Complete study start-up and regulatory deliverables according to the SSU RA management plan • Liaise with SSU/regulatory project teams, authorities, vendors, and investigative sites • Independently manage low-complexity study start-up activities under senior guidance • Prepare, collect, review, and submit regulatory information to national authorities and ECs/IRBs • Collect, review, and track essential documents for site initiation and activation • Investigate incomplete, inaccurate, or missing documents • Prepare study team reports and updates on essential document status • Draft, negotiate, finalize, and execute clinical site and ancillary agreements and amendments • Conduct site outreach and manage confidential disclosure agreements • Coordinate documents and activities leading to investigational product release, site activation, and site initiation • Review labels, patient information sheets, diary cards, insurance, and related documentation for ICH GCP and country-specific compliance • Arrange and review translations of essential documents • Contribute to regulatory and study start-up strategies and plans • Complete project trackers, study portal and TMF filing, and submission dossier QC • Ensure deliverables and essential document submissions meet project timelines, expectations, SOPs, and study-specific requirements

🎯 Requirements

• Graduate degree in Chemistry or Life Sciences, Pharmacy, MD, or equivalent combination of education and experience • Previous experience within the pharmaceutical or CRO industry • Good knowledge of ICH GCP and national regulations for territories of competency • Good written and verbal communication skills • Proficiency in English, written and verbal

🏖️ Benefits

• Remote work • Collaborative, international team • Career growth opportunities • Work-life balance • Supportive culture • Opportunity to work with experts in clinical research, pharmacovigilance, and quality consulting