R&D IT Business Application Lead - Key User (m/w/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 are responsible for supporting the R&D organisation in terms of technical aspects and business processes.
- You implement new R&D applications and projects, manage existing applications and processes, ensure their compliance, as well as provide R&D support to the business units.
- You create validation plans, requirements, test scripts and other validation documents.
- You lead and facilitate meetings, interact with vendors and internal R&D departments and build strong relationships.
- You manage vendors, which can include licensing, budgeting, service agreements, etc.
- You gather requirements, document and operationalise complex processes.
WHAT WE EXPECT FROM YOU:
- Degree in Computer Sciences/Information Systems or related discipline.
- Minimum of 3-5 years’ experience in a position of equal scope and responsibility.
- Experience with LIMS (Chromeleon, Maqsima Lab+), SAS, strongly preferred.
- Experience with Clinical (CTMS, Transperfect eTMF), Regulatory (RIMS, docuBridge, drugTrack), Document Management (CARA), and Quality (Master Control) systems also preferred.
- Knowledge in the area of validation of computer systems in an environment of medicinal products and medical devices as well as knowledge of EU, ICH and FDA guidelines and the GAMP 5 principles.
- Experience with CSA and ALM (Polarion) tools preferred.
- Ability to prioritise and solve problems, propose solutions and implement changes.
- Strong interpersonal, teamwork, organizational and workload planning skills.
- Excellent written and oral communication skills.
- Ability to present ideas in a business-friendly and user-friendly language as well as being able to develop and visually present ideas and concepts to both IT and business representatives.
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/