Clinical Writer – Medical Devices
Europe & United States
Qserve is constantly looking for professionals at different career levels with experience in regulatory affairs, quality assurance or clinical affairs in medical devices and in-vitro diagnostics.
We are a worldwide operating organization that is fast-growing offering consulting, training and CRO services to the medical device and in-vitro diagnostics sector. We are headquartered in The Netherlands, and have local teams in Germany, UK, Belgium, USA and China.
Is this your DNA?
Do you find pride in supporting customers in line with professional and ethical values? Do you have a practical approach and like being creative in finding solutions? Do you get energy from working with customers and colleagues in different parts of the world, enjoying the flexibility of working from home, and developing yourself in a highly professional environment? Please take a look at our career opportunities at Qserve. We would like to get in contact with you!
This is what you will be doing at Qserve:
As a Clinical Writer at our company you provide support to our clients in the medical device industry with conducting literature searches, and (re)writing of clinical documentation based on regulatory requirements (EU MDR, FDA). This includes clinical evaluation plans and reports (CEP and CER), post-market surveillance reports (PMS), periodic safety update reports (PSUR), clinical investigation plans, study reports and scientific publications. In addition, you are able to assist our clients with developing investigator newsletters, promotional materials and training slide decks in support of their studies. You will ensure accuracy and consistency across all clinical content. In cases where the data is collected under a Clinical Investigation Plan, you will contribute to developing the clinical study documentation following ISO14155. Writing clinical reports is your key competence!
And this is what you will bring:
- You have a technical or scientific degree (MSc or PhD) in chemistry, (medical) biology, biomedical technology or similar.
- Minimal 3-5 years working experience with writing (scientific) documents and proven knowledge of medical (device) terminology.
- Ability to develop clinical strategies independently with clients
- Knowledge of global Medical Device Regulations (EU MDR, FDA, PAL, TGA, etc.), particularly in relation to generating and evaluating clinical data of medical devices.
- Pragmatic, accurate, analytical, enjoying a mix of activities with various device technologies, business processes, regulatory and clinical challenges.
- Communicative and service oriented, supporting a wide variety of clients.
- Strong organizational skills, detail oriented to deal with different projects at the same time.
- Fluent in English.
- Legally able to work in The Netherlands, Belgium, Germany, United Kingdom or The United States. Freelance options are possible as well.
Why choose Qserve?
Qserve has an international and dynamic work environment in which you can learn, develop and operate in the innovative, fast moving medical device and in-vitro diagnostics sector. We offer flexibility and diversity in terms of clients, devices, technology, roles (author, reviewer, expert, trainer, auditor, etc.) and projects. Work together, learn from and be part of a strong international team with technical, clinical, regulatory and quality competences (all together over 800 years of experience).