Clinical Specialist Medical Writer
- Experience Level
- Experienced (non-manager)
My client is the leading expert in self-care Medical Devices. We design, develop and manufacture innovative self-care products for global pharmaceutical companies. Our products empower users across 5 continents to take control of their health without doctor intervention.
The product development process brings together the formulation of proprietary ingredients and medical applicators to deliver user-centric treatments supported by clinical substantiation and intellectual property.
With the upcoming Medical Device Regulation taking effect, the robustness of clinical data is a hot topic. To strengthen our Research and Development team we are looking for a Clinical Evaluation Specialist / Medical Writer that can develop and execute the clinical strategy within the framework of the new regulation. An entrepreneurial individual with expertise in clinical evaluation and investigation, that can lead a small cross-functional R&D team in the product development process.
The primary role is to ensure compliance of the clinical development plans with the Medical Device Regulation, including gap analysis of existing data and strategy for new product developments. This will entail the end-to-end management of clinical trials and authoring of clinical evaluation reports (CERs) per MDR 2017/745 and MEDDEV 2.7.1 Rev 4, as well as post market clinical follow-up plans and CER updates to maintain EU product conformance.
- Perform comprehensive literature searches to develop in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies and stay informed about applicable clinical landscapes and trends.
- Combine an understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge to support Regulatory Affairs submissions for CE marking of new devices and maintaining CE marks for existing devices.
- Extracts data from included studies, interpret study results, synthesizes literature, and prepares summaries into formal reports.
- Organizes clinical data from literature into references, graphics, tables, and data listings
- Prepare regulatory documents and responses to regulatory authorities, specifically working on Clinical Evaluation Reports (CERs)
- Manage CER timelines required by product development teams and global regulatory bodies by utilizing the appropriate project management tools.
- Communicates with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, and Regulatory Affairs relating to the CER process to identify the necessary clinical and technical information for the assigned project.
- Ensure documents are produced per procedures, internal and external guidelines, and electronic templates
- May author protocols and routine clinical study progress reports.
Desired technical skills and experience
- Master’s degree required, preferably with a scientific emphasis.
- PhD preferred or 5 years of documented scientific/research experience.
- 2 years experience in clinical evaluation report writing (CER) in the medical device industry.
- Experience writing study protocols and final study reports
- Training and degree in science, engineering, or medical fields. Scientific/research background (i.e., understands research design, methodology, and statistics).
- Working knowledge of MEDDEV 2.7/1 Rev 4, MDD, and EU MDR 2017/745.
- Working knowledge of ISO 13485 and ISO 14155.
- Working knowledge of biomedical databases (i.e., Pubmed, Embase).
- A thorough understanding of the National Library of Medicine’s Medical Subject Headings (MeSH).
- Proficient in document development and management software skills: Word/ Excel/ PowerPoint.
Desired personal skills
This position requires a hands-on professional who is detail-oriented with an ability to prioritize, plan and organize. A quick-learning team player with excellent and effective problem-solving skills and the skills to manage both internal cross-functional teams as well as external contract research organizations to meet project deadlines.
We offer you
- A professional and challenging environment;
- An opportunity to make a notable impact on health products all over the globe;
- A competitive salary package incl. pension plan;
- A holiday allowance of 28 days per year;
- A healthy work-life balance.
My client is a dynamic, fast growing company working with the best of the pharmaceutical industry. You will gain experience with product development in a strict regulatory environment; at the same time you are working in an entrepreneurial organization in a team of enthusiastic young professionals that have the mentality of work hard, play hard. If this sounds like you, contact us and let’s talk!
- clinical report writing: 2 years (Required)
- Master's (Required)
- Amsterdam (Preferred)
- Dutch (Preferred)
- English (highly proficient in spoken and written) ) (Required)
- Temporarily due to COVID-19
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