United States, Pennsylvania, PhiladelphiaClinical 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.
Getting excited about a career in the dynamic and innovating world of medical devices? Then please submit your resume and motivation!
How we hire
We have a thorough and flexible hiring process, to ensure we make the right decision and to help you to decide if we're the right fit for you.
First of all, thank you for your interest in a career at Qserve. All applications are reviewed by our HR department in close cooperation with the respective hiring manager. If we see a potential match, you will be invited for a first interview.
At this stage, we would like to take a deeper dive into your experience and what you could bring to the team. Besides that, we would love to tell you more about our company and people. You can expect several interviews with different relevant stakeholders.
Are you ready to sign your contract? Our HR colleague is looking forward to informing you about the employment conditions at Qserve, both primary and secondary. Your adventure at Qserve Group officially starts here!
We know how important it is to provide new hires with an engaging onboarding and warm welcome. As part of the structured program, you will be introduced to representatives of all our global teams and departments.