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 companies.
The CER specialist will have an in-depth knowledge of medical writing and will be responsible for writing and developing Clinical Evaluation Reports (CERs) under the MEDDEV 2.7/1 revision 4 and EU MDR guidelines. This individual 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. You will work 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.
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 complete CER 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
2 openings. Telecommuting is allowed.
Additional Salary Information: Full Benefits included.
Internal Number: CER092018
About Network Partners
Network Partners provides specialized resources to help Medical Device and Pharmaceutical companies get from where they are to where they want to be. Providing consulting and contract staffing via a team of qualified professionals in the areas of packaging engineering, regulatory affairs, labeling, cold chain, quality management systems and project management allows leaders to turn their under-resourced teams into productive work groups and deliver on-time and on-budget results.
Network Partners gives each employee a unique opportunity to make a difference at industry-leading companies while working for a spirited, high-growth organization. In addition to wildly competitive compensation, our team enjoys a wide range of best-in-class benefits and flexible work arrangements. Visit networkpartners.com - Dare to have a different perspective!