Network Partners is seeking to hire an experienced Medical Writer to our team that will be responsible for writing and developing Clinical Evaluation Reports (CERs) under the MEDDEV 2.7/1 revision 4 and EU MDR guidelines for our client partners.

 

Responsibilities include the following and are not limited to:

  • Analyzing and synthesizing pre-clinical and clinical data, risk management assessments, published literature, clinical investigation results, post-market surveillance data, and field performance data to evaluate product safety and performance.
  • Performing published literature searches, assessing literature for product safety and performance data, writing literature reviews, and creating bibliographies.
  • Writing and compiling CERs in compliance with MEDDEV 2.7/1 rev. 4 and EU MDR.
  • Interfacing with key functional clients to obtain necessary information and documents required for the development of CERs.
  • Developing therapeutic and device operation knowledge for applicability to the clinical assessments and development of the CERs for corresponding product(s).
  • Providing input and feedback to determine appropriate clinical evaluation strategies to write/update CERs.
  • Collaborating with medical writing director and clients to assure high quality and successful completion of deliverables.

 

Requirements:

  • Bachelor’s degree in sciences or related field (i.e. biomedical engineering, systems, reliability)
  • Industry medical writing experience – must have writen CERs in a previous role.
  • 4+ years experience (2+ with Masters or 1+ with Doctorate, or Board Certified MD/DVM/PharmD)
  • Ability to travel (less than 10%) for applicable conferences, trainings or client meetings

 

Preferred Requirements:

  • Advanced degree in sciences or related field (i.e. biomedical engineering, systems, reliability)
  • Medical device experience
  • PMA/CE mark submission experience
  • Clinical research experience
  • Professional clinical research certification

 

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