Global's Clinical Evaluation Report (CER) Writing Internship Program

What is the CER Writing Internship Program?

The Global CER Writing Internship Program is an intensive 12-month training program designed to teach novice writers the skills and techniques required to become a CER writer. During the first six months of the program, interns work closely with an experienced instructor in an inquiry-based, engaging curriculum to develop competency in all areas of the CER writing process and gain an understand of related regulations and guidelines.

In the second half of the program, the 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 develop their project management skills 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.

Why we’re doing it

The Global CER Internship Program was developed to address several recurring needs.

  • Finding CER writers is hard; finding great CER writers is even harder!
  • While there are many fine CER writers out there, Global has found that training our own writers in-house is the best way to ensure we can meet the challenges of the industry and adapt to client needs.
  • With a strong training program, Global can identify smart, talented researchers, writers, and professionals and teach them CER-specific writing skills.

Internship Timeline

The internship is paced to cover specific information on a set timeline, pending the needs of our clients. By the end of each major milestone, interns will have covered the following information:  

By The End of Month 1

  • Article Extractions
  • Safety and Performance Objectives

By The End of Month 3

  • Clinical Evaluation Plan (CEP)
  • State of the Art
  • Literature Screening and Appraisal
  • Vigilance
  • Competitor Devices

By The End of Month 5

  • Gap Analysis and Identifying Inputs
  • Addressing Client Needs
  • Complete a Practice CER
  • Begin Client-Facing Duties
  • Equivalence
  • Data Analysis

By The End of Month 12

  • Project Management Skills
  • Fact Check/QC
  • Working with Other Writers
  • PMS/PMCF Plans
  • SSCPs
  • Client-Facing Work

Interested applying to the CER Writing Internship Program?

Are you a medical device company interested in training your own in-house writers?

The principles from our internship program have been distilled into an intensive boot camp that can be used for training in-house staff. Check out our Global CER 101 Boot Camp page for more details. 

We provide healthcare innovators unparalleled regulatory support and writing services through customized collaboration, problem solving, and technical expertise.

+01-253-243-6121

info@globalrwc.com

27721 105th Ave SE Kent, Washington 98030