Medical Writer (m/f/d)

Deine Daten werden DSGVO-konform behandelt und nur an Croma-Pharma weitergegeben.

Croma-Pharma

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

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

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