Junior Associate Specialist Regulatory Affairs (m/f/d) | Merck Sharp & Dohme Gesellschaft m.b.H.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. 

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

We are continually striving to improve the understanding of health care within the local community. Our site in 1100 Vienna (ICON TOWER) is a strategic location for the distribution of our high quality and innovative health care products, as well as digitally integrated solutions for our patients and clients. To ensure sustainable company growth, we continually aim to offer attractive career opportunities for more than 170 employees at our Vienna site.

Junior Associate Specialist Regulatory Affairs (m/f/d)
Part time 20 hours/week

Aufgaben | Responsibilities

• Responsibility for general department administrative tasks such as: managing invoicing, meeting arrangements, coordinating agendas, taking and circulating meeting minutes, travel arrangements, external training arrangements, maintaining and updating different types of lists, as applicable
• Support for administrative management of Regulatory Affairs budget
• Archiving tasks such as archiving of different types of documents (including official submission documents).
• Supporting the local Trainings & Compliance Officer: e.g. updating Regulatory Affairs training lists & archiving of training certificates
• Assisting in proofreading and QRD check of Summary of Product Characteristics and Patient Package Leaflets and artwork components; performs quality assurance including linguistic check of these documents. These activities are to be performed in a later stage and under supervision.

Anforderungen | Qualifications

• Post-secondary or secondary education in scientific science or equivalent
• Basic medical and scientific understanding and knowledge is preferred
• Basic skills and knowledge of local and EU medicines legislation and regulatory procedures is preferred
• Ability to plan and prioritize tasks to meet company and local objectives
• Good interpersonal and managerial skills, capability of problem resolution and the ability to work in a team environment.
• Commitment, high dedication to quality and the ability to handle multiple priorities simultaneously is a key condition
• IT-skills with regards to Microsoft Office applications (e.g., Word, Excel, PowerPoint) and internal database applications
• Fluent in German and business proficient in English

Angebot | Offer

We offer an attractive salary, outstanding social benefits and an exciting work environment with varied tasks in an international environment. The minimum annual salary for this position is EUR 44.100,- (based on fulltime employment) and varies according to the qualifications and experience of the successful candidate. We are looking forward to receiving your application.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Bewerbung | Application

• Merck Sharp & Dohme Gesellschaft m.b.H.
• ICON Vienna | Turm A, 20. Stock | Wiedner Gürtel 9-13
• Wien 1100