Network Partners has an opening for a remote medical writer (CER specialist) to join our growing medical writing team! We are a spirited, high-growth company focused on the success of our clients and our colleagues. We work for some of the world’s largest and well-known medical device and pharmaceutical companies.
To be successful in this role you must have an in-depth knowledge of medical writing as you will be responsible for writing and developing Clinical Evaluation Reports (CERs) under the MEDDEV 2.7/1 revision 4 and EU MDR guidelines. You must have demonstrated the ability to partner with clinical research, regulatory affairs, quality, product development and biostatisticians to gather clinical evidence required for writing clinical and regulatory documents in compliance with the regulations and expectations of the regulatory bodies. In this role you will be working closely with the medical writing director to complete all assigned projects.
**This role is 100% remote, so if you thrive in a flexible work environment, then this opportunity may be for you.**
For additional information keep reading…
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
- 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