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.
Network Partners is a professional services firm that helps clients complete the work necessary to provide their products to patients. Serving the medical device, pharmaceutical and biopharmaceutical industries with core competencies in Regulatory Affairs, Packaging Engineering, Labeling, Quality and Project Management.
We are one of the fastest growing professional services organizations in the life science industry in the US. We have embarked on a bold mission to change the industry. We are a spirited, high-growth company focused on the success of our clients and our colleagues. With people at our core, we are passionate, hungry and fearless to meet the client’s needs. We are continuous learners that are always looking for ways to better ourselves. It’s the best of both worlds! We are humble, hungry and people smart.
- 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 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
- Orchestrate meetings with cross functional departments to strategize and plan for timely submissions
- Prepare responses to questions (Information Requests and Complete Response letters) from the USFDA
- Participate in project meetings and provide feedback to product development teams on regulatory issues and questions
- Maintain proficiency in worldwide regulatory requirements; monitor changes to regulatory requirements and communicating this information to departments within the business unit that may be affected by these changes; establish and maintain good relationships with agency personnel