Medical Writer (m/f/d) - part-time (20h/week)

at  CROMAPHARMA GmbH

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, edit, compile and maintain documents related to clinical development activities for medical devices and CE marking activities (such as Clinical Evaluation Plans and Reports, Post Market Clinical Follow Up Plans and Reports) according to EU MDR 2017/745
• 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
• Contribute 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, posters 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

  Ihr Profil

• Background in life sciences (Masters´ degree or equivalent is preferrable)

• At least 3 years’ experience in regulatory writing, or extensive relevant medical writing experience through clinical research activities in the pharmaceutical industry, preferably on medical devices
• Knowledge of regulatory writing standards and relevant guidelines (such as EU MDR 2017/745, ISO 14155, ICH-GCP, FDA Title 21 CFR)
• Proven medical/scientific writing skills, with the ability to convey complex data in a clear, concise and correct way and attention to formal details
• Mastery of relevant software tools and literature search platforms, including MS Office suite (Word, Excel, Powerpoint, Sharepoint, Teams), eDMS, MedDRA, EMBASE, Citavi, PubMed, and others
• Oral and written proficiency in English (CEFR level C1 or equivalent)
• German (at least B1) desirable
• Good understanding of the clinical development process, including basic knowledge of statistics and regulatory procedures
• Availability to attend regularly scheduled meetings at Croma headquarters

Excellent planning and organization skills, being able to adapt to fluid timelines, both independently and within a team
Awareness of aesthetic medicine, including minimal invasive procedures and skin rejuvenation

Ability to cross-collaborate with other internal functions in a clear, orderly and polite manner, with a can-do, problem-solving, optimistic mindset

• Collective agreement for the chemical industry, 38 hours a week - the minimum gross salary according to the KV is EUR 58.199,96 for this position. The actual salary depends on the specific qualification and experience.
• Flexible working hours and up to 15 home office days per month
• 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

Please refer the Job description for details