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Medical Writer (m/f/d)

CROMA-PHARMA GmbH -
Leobendorf, NÖ

Jetzt bewerben

Details zur Stelle

Qualifikationen

Master

Vollständige Stellenbeschreibung

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.

Ihre 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

Ihr 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

Experience in medical devices (preferred)
Familiarity with aesthetic or orthopaedic medicine, including minimally invasive procedures

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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Erweiterte Suche

data specialist Jobs in wien, w

Medical Writer (m/f/d)

Investment Manager

Teamlead Performance Marketing (SEA & Display) (m/f/d)

Senior Marketplace Manager - E-Commerce (f/m/d)

Business Process Training Expert (f/m/d)

Assistant Manager, Procurement Consulting (m/f/d)

Senior Market Risk Manager (f/m/x)

Senior Specialist Paid Social (f/m/d)

Sales Executive (market: Austria) - Sherpany

Senior Associate/Manager (w/m/d) in Transfer Pricing

Sr. Sales Recruiter

Brand Manager Specialty Care - Rheumatology & Gastroenterology

Training Manager (m/w/d)

Manager, Procurement Consulting (m/f/d)

Manager, Game & Auction Theory and Negotiation Management Consulting (m/f/d)

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