United States, Massachusetts, BostonClinical Operations
What you'll do
As a Clinical Writer at our company you provide support to our clients in the medical device industry by conducting literature searches, and (re)writing 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!
What you’ll bring to the team
- You have a technical or scientific degree (MSc or Ph.D.) in chemistry, (medical) biology, biomedical technology, or similar;
- Minimal 3-5 years of 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.
Getting excited about a career in the dynamic and innovating world of medical devices? Then please submit your resume and motivation!
How we hire
Everything you need to know about your application process at Qserve Group
Getting to know you
In the first call, let our recruiter learn about you and your story to check a potential fit for Qserve. This is also a chance for you to ask first questions about the role and company.
In this meeting, your future manager takes a deeper dive into your experience and what you could bring to the team. Expect questions on how knowledgeable you are in your area of expertise.
You made it to the very last stage! Here we have a final call to ask some additional questions. This meeting will be between you, your future manager and a team member.
Is there a match? Then we will gladly make you an offer consisting of a suitable salary and our employment conditions. Do you accept our offer? Your adventure at Qserve Group will start!