- Leobendorf, Österreich
- Mit Berufserfahrung
- Feste Anstellung
- Vollzeit
- Hybrid
- Homeoffice möglich
CROMA-PHARMA is an internationally active pharmaceutical company with its headquarter in Leobendorf, Korneuburg district, in the north of Vienna. Many years of experience in the manufacturing of products based on hyaluronic acid and a unique level of expertise in the field of aesthetic medicine have made CROMA-PHARMA a globally renowned specialist in the dynamic and versatile business of anti-aging.
At Croma-Pharma, we are committed to developing and marketing innovative products that help our customers improve their well-being. Join us and grow with us.
Deine Aufgaben
- Write, review and maintain clinical and regulatory documents across the product lifecycle (e.g. Clinical Evaluation Plans and Reports, PMCF Plans and Reports, PSURs, Investigator’s Brochures)
- Ensure compliance with applicable regulations and guidelines (EU MDR 2017/745, ICH-GCP, ISO 14155, FDA 21 CFR)
- Coordinate document review and approval processes, including comment reconciliation with internal stakeholders and external medical experts
- Support CE marking and global regulatory submissions
- Contribute to the continuous improvement of internal processes, SOPs and working practices
Dein Profil
- Background in life sciences or veterinary medicine (Master’s degree or equivalent preferred)
- At least 3 years of hands-on experience in medical or regulatory writing within the pharmaceutical or medical device industry
- Strong knowledge of relevant regulatory frameworks (EU MDR, ICH-GCP, ISO 14155, FDA 21 CFR)
- Proven ability to translate complex clinical and scientific data into clear, structured and high-quality documents
- Excellent English skills (C1 level or equivalent); German (at least B1) is desirable
- Experience with relevant tools and platforms (MS Office, eDMS, PubMed, EMBASE, etc.)
- Solid understanding of clinical development processes, including basic statistical concepts
- Strong planning and organizational skills, with the ability to adapt to dynamic timelines
- Collaborative mindset with clear and structured communication skills
Deine Benefits:
- Collective agreement for the chemical industry, 38 hours a week – the minimum gross salary according to the CA is EUR 62.765,08 for this position. The actual salary depends on the specific qualification and experience.
- Flexible working hours and home-office
- Good public transport connections and free parking spaces
- Croma restaurant with meal allowance and in-house fitness center
- Pension and health care (company doctor and employee assistance programs)
- Professional development
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