QbD Group’s team offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, ATMP and Medical Devices/IVD. We are always looking for the next QbD’er in Medical writing.

What do we expect from you as a Medical writer?

The Medical Writer is responsible for authoring, reviewing and editing clinical trial-related documents scientific publications. He/she supports our customers with tailored advice on clinical evidence strategies He/she is responsible for presenting clinical data objectively in a clear, concise format and ensures timely delivery of these documents in accordance with all applicable quality and/or regulatory standards or requirements.

• Manages the development and writing of clinical and regulatory documents including clinical study protocols and reports, investigator’s brochures, informed consent forms, diverse study plans, annual reports, clinical evaluation reports in accordance with SOP’s of QbD Clinical and/or client and with applicable standards like ICH GCP, ISO 14155 and other regulatory requirements.
• Develops clinical evidence strategies for our customers and writes Clinical Evaluation Plans.
• Performs literature reviews for medical devices as part of clinical evaluation reports.
• Contributes to the design and maintenance of templates, standards for protocols, marketing materials
• Keeps stakeholders informed on document progress and other project-related information

Who are we looking for?

• PhD, master’s degree in biological or (para-) medical sciences or equivalent by experience.
• Certification as medical writer by acknowledged European (EMWA) or other (e.g. United States) professional organization is considered an additional advantage.
• Minimum of 5 years’ experience in clinical research and clinical evidence strategies of medical devices.
• Minimum of 2 years’ experience with systematic literature research and with writing of study/regulatory documents
• Knowledge of Medical Devices Regulations and understanding of Clinical Evaluations is a must.
• Strong experience using Microsoft applications (Excel, Word, PowerPoint, Outlook) and advanced features.
• You have a critical mindset, excellent communications and organizational skills.
• Demonstrates ability to interpret clinical data and communicates scientific or medical information in a clear and concise manner
• Demonstrates ability to understand diverse scientific topics and to address complex issues with a structured approach
• Demonstrates ability to work independently
• Experience with project management
• Knowledge of ICH and EU and US regulatory requirements, including requirements for preparation of key clinical and regulatory documents
• Team player with customer-oriented approach and strong sense of urgency
• Demonstrates ability to identify and adapt to shifting priorities and competing demands
• Sensitive to cultural differences
• Fluent in English. Other languages are a plus.

A true QbD’er can be recognized by the following qualities:

• Resilient: Your strong and positive attitude helps you overcome any challenge
• Hungry for knowledge: You are always open to learning
• No non-sense mentality: you can be straightforward in a respectful way
• Innovative: You are constantly looking for new and better solutions
• (Not too) serious: your job is serious, but you don’t take yourself too serious.

What’s in it for you?

• QbD offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations.
• Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed.
• As we’re a knowledge-based company, you’re guaranteed to embark on a continuous journey of learning and development.
• Be part of our global success story. As an award-winning company we value everyone’s contribution and celebrate achievements together

Our promise to you:

• As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.
• Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.
• In short … We stand for? JPEG: Joy in Partnership, going for the Extra mile to Get things done!
  

Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!