CROMA-PHARMA is an internationally active, family-owned pharmaceutical company. 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 expanding and therefore looking for a/ an
Medical Writer (m/f)
We are searching for applicants who want to make a sustainable contribution to our success as a family- run Austrian company.
- Creation and update of clinical evaluations following the requirements of the MedDev and corresponding guidelines and laws
- Preparation of clinical submission documents for a regulatory audience, within a team environment and ensuring process, content, and submission/document planning expertise
- Preparation and maintenance of (M)SOPs relevant to medical writing activities and tasks
- Participation in the development of processes and tools related to document authoring, management, and quality control to develop best-in-class processes, tools, and standards for generation and delivery of high-quality documents
- Ensuring critical review and interpretation of clinical efficacy and safety data for appropriate medically relevant and Standard Operating Procedure (SOP)/Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH)-compliant presentation
- Review and comment on documents in clinical program (e.g, protocols, IBs)
- Administrative adjustments in the clinical sections of technical documentation in cooperation with RA Croma
- Literature order and management
- Regular research and evaluation of clinical data from the literature in the context of the Post market surveillance
- Preparing publications which contain clinical data and opinions in cooperation with CROMA internal departments
- Error analysis in the framework of CAPAs (corrective and preventive actions) in collaboration with QA
- Excellent written and verbal communication skills
- Prior clinical study report and Investigator's Brochure generation experience
- Prior experience with Clinical Evaluation Reports for medical devices
- Prior experience in writing scientific publications
- Prior experience with submissions in Common Technical Document (CTD/eCTD) format
- Detailed and experience-based understanding of applicable regulations and guidelines (e.g. AMG, MPG, ISO 14155, ICH, MedDev)
- Familiarity with statistical and data output
- Fluency in English and German (written and spoken)
We offer applicants a varied position in a rapidly expanding company, plenty of room for growth and development as well as multitude of social benefits. If you would like to be part of a dynamic team, we look forward to meeting you.
The minimum salary for this position according to the applicable collective bargaining agreement is EUR 31.946,88,- gross p.a. which can be increased to match your qualification and experience.
Please upload your detailed application to our online portal.
attn. Ms. Nathalie Struger
Human Resources Operations Manager
Please note that in order to meet the legal data protection requirements, we can only accept applications that have been submitted via our electronic application device. Upon submission of you application you will receive an acknowledgement of receipt.