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.
- Bachelor’s degree in sciences or related field (i.e. biomedical engineering, systems, reliability)
- Industry medical writing experience – must have written 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
- 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