Regulatory Writing Internship
The Introduction to CER writing training is a 10-hour interactive course that focuses on the practical aspects of CER writing. Over a period of 5 days, the instructor will take you through the steps of the clinical evaluation, bridging the gap between regulatory requirements and their practical implementation, including tips and tricks for effective writing.
What is the Regulatory Writing Internship?
The GLOBAL Regulatory Writing Internship Program is a rigorous 12-month training program designed to teach novice writers the skills and techniques required to become a successful writer in the EU MDR space. During the first half of the program, interns work closely with an experienced instructor in an inquiry-based, engaging curriculum to develop competency in key areas of the clinical evaluation writing process and gain an understand of related regulations and guidelines.
In the second half of the internship, interns enter a mentorship program in which they apply their training to real-life CER work under the close supervision of a lead CER writer. During this time, interns work closely with their mentor to gain additional experience on CER strategies, project management, and regulatory knowledge while continuing to produce high-quality work.
By the end of the internship program, successful interns are prepared to take ownership of their own CER projects and may be considered for a salaried writing position at GLOBAL.
Why we’re doing it
The GLOBAL Regulatory Writing Internship Program was developed to address several recurring needs.
- Finding CER writers is hard; finding great CER writers is even harder!
- Hands-on training for CER writing is hard to come by, especially for those new to the industry
- Smart, talented researchers, writers, and professionals need a gateway into this field
What’s covered?
During the internship program, interns will be trained and have exposure to all major components of CER writing. The following key topics and skills will be covered in the internship program.
- Practical application of medical device regulations and guidelines
- Understanding and evaluating clinical literature
- Establishing safety and performance objectives
- Literature screening and appraisal
- Demonstrating state-of-the-art
- Understanding and using key inputs
- Drafting all major sections of a CER and CEP
- Basic introduction to PMS/PMCF Plans and SSCPs
- Developing equivalence arguments
- Analyzing CER data
- Successful project management skills
- Fact checking and QC
Internship Requirements
- Ability to work full-time (32+ hours/week)
- Masters or Doctorate in a STEM or writing field
- US resident
- Interest in a long-term career in regulatory writing
Interested applying to the
Regulatory Writing Internship?
We provide professional drug and device consulting, regulatory submissions support, and strategic writing for clients all over the world.
Are you a medical device company interested in training your own in-house writers?
GLOBAL provides customized training on many of the principles and best practices taught in our internship program. Check out our GLOBAL CER Training page for more details.
