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Role and Responsibilities:
- Assume leadership during study set-up, developing start-up strategy and coordinating regulatory deliverables.
- Serve as main point of contact for all project-specific study start-up activities.
- Prepare, collect, and review regulatory information for submissions and maintenance.
Qualifications:
- Bachelor's Degree in Chemistry, Life Sciences, Nursing or equivalent experience.
- Minimum 5 years within pharmaceutical/CRO industry with proven ability to manage multi-country projects.
- Excellent organizational, planning, and problem-solving skills with strong knowledge of ICH-GCP.
Why Ergomed:
- Training and career development opportunities internally.
- Strong emphasis on personal and professional growth.
- Friendly, supportive working environment with global colleagues.
Ergomed
Ergomed is a mid-sized contract research organization specializing in oncology and rare disease. The company has a global presence with operations in Europe, North America, and Asia, and emphasizes employee well-being, work-life balance, and career development.