CER Writer
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
