CROMA-PHARMA is an internationally active, family-owned 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.
We are searching for applicants who want to make a sustainable contribution to our success as a family- run Austrian company.
We are expanding our Clinical Development department and therefore looking for a/ an Medical Writer.
- Write, edit, compile and maintain documents related to clinical development activities and CE marking activities (such as Clinical Evaluation Reports and Plans, Post Market Clinical Follow Up Plans and Reports) according to 93/42/EEC and 2017/745/EU
- Coordinate and manage the review and approval process of documents, including comment reconciliation and timely completion
- Review and edit documents prepared with the help of service providers and medical experts
- Contribution to the continuous improvement of internal processes, maintaining of SOPs, definition and implementation of working practices, etc.
- Support the clinical team in publishing study results in peer- reviewed journals and through poster and slide presentations at international congresses
- Support global submissions to regulatory authorities including writing of clinical study reports, investigator’s brochures, and CTD summaries and overviews
- At least 3 years’ experience in regulatory writing, or extensive relevant medical writing experience through clinical research activities in the pharmaceutical industry
- Life-science background
- Knowledge of regulatory writing standards and relevant guidelines (such as 93/42/EEC,2017/745/EU, ISO 14155, ICH-GCP, FDA/CFR)
- Proven writing skills, with the ability to convey complex data in a clear, concise and correct way and attention to formal details
- Good understanding of the clinical development process, including basic knowledge of statistics and regulatory procedures
- Used to work to tight timelines both independently and within a team
- Fluent in English (oral and written) and German, preferable
We offer a varied work in a rapidly expanding company with diverse development opportunities and company benefits, as well as flexible working hours and home office. If you want to become part of a dynamic team, we look forward to meeting you!
For this position, a salary of EUR 44,000, - (full-time) applies gross p. a. Willingness to overpayment exists and depends on the specific qualification and experience.