Your tasks

Your main responsibility will be to edit and/or write regulatory and clinical content and documentation, related to new drugs or clinical trials

You will draft and manage regulatory and clinical research healthcare documents, including articles and white papers. In this context you will also work with external service providers, such as healthcare-specialized agencies, to compile and organize information and create paperwork that will be reviewed by government or regulatory agencies, such as the EMA or FDA. In this context, you will also be in close contact and exchange with the relevant internal specialist departments. Other responsibilities include conducting extensive research on medical-related topics to ensure that all content is factual and accurate and complies with the medical regulatory standards and guideline requirements.

We look for someone who is a healthcare enthusiast and who is capable of assimilating and interpreting scientific content or a wealth of clinical efficacy and safety data with adeptness in ability to translate into a logical, scientifically balanced compelling medical story for appropriate audience.

• Preparation, initiation and managing of scientific documents (e.g. Clinical Study Protocols or Clinical Study Reports) and publications
• Ensuring competent communication and information on pharmaceutical-medical issues internally and externally
• Cooperation with R & D in the preparation and updating of Investigator's Brochures
• Cooperation with Global Safety
• Collaborate with Regulatory Affairs on clinical summaries and modules for marketing authorisation applications as well as deficiency letters, orphan applications, Addenda to Clinical Overviews and Pediatric Investigation Plans

Your duties

• Medical, pharmaceutical or scientific background
• At least 2 years of clinical and regulatory medical writing experience, preferably in the medical and pharmaceutical industry
• Experience in gastroenterology and hepatology is a strong advantage
• Excellent knowledge of medical laws and regulations
• Excellent attention to detail and superior ability with respect to consistency
• Excellent English and German verbal and written communication skills, expert knowledge of medical terminology
• Clarity and accuracy is natural for you
• Proficiency in Microsoft Office is a must, Prism Graph Pad or Adobe Illustrator knowledge is desirable

Your benefits

• Supportive, respectful and appreciative work atmosphere in a dedicated team
• Diverse learning culture and individual development opportunities
• International and growing family business with short decision-making processes, financial independence and long-term perspective
• New work, flexible working hours and mobile working
• Wide range of benefits (free beverages, health and sports benefits, canteen, JobRad)
• Comprehensive onboarding and mentoring program

If you have any questions, please do not hesitate to contact us at personal@drfalkpharma.de or call + 49 761 1514-102. We look forward to receiving your application via our online portal.