Medical Writer - Medical Devices

North East / Philadelphia, Pennsylvania / Silicon Valley, California 

Minimum 5 years working experience in Medical Devices     

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? 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 Medical Writer at our company, you provide support to our clients in the medical device industry with the (re)writing of clinical documentation such as clinical evaluation reports (CER), clinical investigation plans, study reports, scientific publications, periodic safety update reports and summaries of safety and performance. In addition, you are able to assist our clients with developing investigator newsletters, promotion and information materials, 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), chemistry, (medical) biology, biomedical technology or similar. 
  • Minimum 5 years working experience with writing (scientific) documents and proven knowledge of medical (device) terminology
  • Knowledge of Medical Device Regulations (EU MDD, FDA, PAL, TGA, etc.) particularly in relation to the clinical development of medical devices. 
  • Pragmatic, enjoying a mix of activities in business processes and Clinical affairs.
  • Communicative and service oriented, supporting a wide variety of clients from small start-ups to large multi-nationals, accurate and analytical.
  • Strong organizational skills, detailed oriented to deal with different projects at the same time.
  • Fluent in English. 
  • Working permit and driver’s license for the USA. 


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 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, regulatory, quality and clinical competences (all together over 500 years of experience). And last but not least, we offer a balanced set of core benefits that we believe are important to all employees. 


“Global reach, practical approach, experienced team”

 

Interested? 

Getting excited about a career as a consultant in the dynamic and innovating world of medical devices? Then please submit your resume and letter of motivation tocareers@qservegroup.com or use our application form. For more information about our company, you can always visit our website or reach out to Mindy McCann at mindy.mccann@qservegroup.com (East Coast) +1 424 271 8169 or Keith Morel at keith.morel@qservegroup.com (West Coast) or call +1 551 227 4409.


The function is mainly home-based; we expect our consultants to work at the client location, from home or from our offices Redwood City (CA) or Philadelphia (PA) depending on the need.