(Senior) Clinical Scientist (m/f/d)

(Senior) Clinical Scientist (m/f/d)

Merz Aesthetics is an international company in the field of aesthetic medicine. Our broad product portfolio is synonymous with top quality in each of their categories and is highly regarded by healthcare professionals worldwide. As Merz Aesthetics, we are part of the Merz Group with our EMEA headquarters located in Frankfurt am Main, Germany. Our global head office is located in Raleigh, North Carolina, USA. Every day, more than 1,600 employees in 36 countries are committed to restoring and maintaining the skin's beauty. Would you like to become part of our success story? Then join Merz Aesthetics!

THE FOLLOWING RESPONSIBILITIES ARE AWAITING YOU:

• You provide clinical/scientific guidance for activities related to the development/validation of project specific clinical outcome assessments (COAs) for clinical studies
• You are responsible for the clinical/scientific input during the conduct of clinical development projects / life cycle management and studies (design, progress, quality of information and data) as member of clinical research teams or as R&D lead of an early development project
• You prepare and develop clinical study outlines and coordinate the creation of clinical study protocols (incl. amendments) and clinical study reports in compliance with development plan/ life cycle management ensuring high quality standards for key study documents
• You ensure data integrity and clinical/scientific plausibility of clinical data and statistical outputs (raw data)
• You are responsible for the clinical/scientific input for clinical parts of key regulatory and project documentation for medicinal products and medical devices including but not limited to Clinical Evaluation Report (CER), SMPC, Investigator Brochures, Instructions for Use, PMCF plan/report, DSUR, PSURS, briefing packages/list of questions for scientific advice meetings and Public Disclosure data sets
• You provide clinical/scientific and clinical guidance of due diligences / in-licensing of products / evaluation of external and internal project  ideas (including consultation with external experts, KOLs)
• You provide clinical/scientific input for clinical development plans based on existing product information to comply with clinical development strategy and with regulatory requirements to achieve market approval in key countries
• You author, prepare and develop scientific publications based on clinical study results, present study results at external, conferences and internal meetings

WHAT WE EXPECT FROM YOU:

• A Master’s Degree in Life Sciences, preferably with PhD, DrPH, PharmD, etc
• Mandatory experience in the development and use of clinical outcome assessment (COA) tools including patient reported outcome tools, clinician reported outcome tools and/or photo scales
• Preferred at least 5 years of experience in clinical research gained in pharmaceutical industry/CRO or medical device business; experience in aesthetic medicine as a plus
• Mandatory fluent in English (spoken and written), good verbal and written communication skills in German as a plus
• Excellent scientific writing and presentation skills 
• Knowledge of relevant regulatory requirements and regulations for clinical development of medicinal products and medical devices
• Experience and competency in clinical research design and methods, including working knowledge of ICH and GCP guidelines, and in critical  review of scientific literature and essential clinical trial documents

WHAT YOU CAN EXPECT FROM US:

• Putting people first: You can expect to find an open work culture with flat hierarchies and short decision-making paths at Merz Aesthetics. You will collaborate with colleagues from all around the globe. And if life takes an unexpected turn and you need help or advice, then you can always rely on our Employee Assistance Program.

• Family and work: Our employees should be able to reconcile their family and work commitments. That’s why you’ll find, for example, company day care centers at our locations. We have been awarded the “Family-Friendly Company” certificate from the Hertie Foundation for our commitment to family and work.

• Work-life harmony: Our time is precious; our daily routines individual. To help you reconcile work and leisure time with their conflicting demands, we have adopted contemporary flexible working time models. We offer you flextime/trust-based working time and mobile working. Our employees also benefit from generous arrangements for annual leave.

• Ongoing training: Your personal and professional development is the key to success for us. To this end, we hold regular development discussions and facilitate a wide range of management and specialist training courses, soft skills courses, e-learning courses, language courses and coaching sessions.

Find out more about our benefits here.

We are looking forward to your application!

You can find more information at https://merz-aesthetics.info/