Key skills
Risk Management
About this role
Work Flexibility: Hybrid
What you will do:
- You will work closely with cross-functional teams (Regulatory, Clinical, Quality, Marketing) ensuring successful preparation of high-quality submission-ready clinical documents such as clinical evaluation documents, Post Market Clinical Follow-up documents, Summary of Safety and Clinical Performance and Clinical Study documents.
- Compiles clinical evidence from multiple sources such as current and past clinical trials, post market clinical follow up data and literature review updates, ad-hoc analysis, meta analyses, or other sources of safety and performance data (e.g. IIS clinical data, as available) and synthesizes the information in support of EU- MDR submissions, required CERs, and annual updates.
- Responsible for the development and completion of Clinical Evaluation Reports (CERs) for new medical devices to support product registrations internationally, maintain periodic updates, perform gap analysis, and revise existing CERs.
- Collaborate cross-functionally to provide input for design teams for Clinical EU MDR documentation.
- Work in a cross-functional team to support clinical study protocols and reports, data summaries from raw data and document strategies.
- Prepare literature searches for drafting document content. Interprets literature information and synthesizes the information in clinical regulatory documents.
- For all documents, coordinates and manages the review process, and leads discussions on document revision.
- Challenge conclusions when necessary. Independently resolves document content issues and questions from external and internal reviewers and ensures timely approvals from all reviewers.
- Assist in the development of internal procedures, templates and style guides and serve as a subject matter expert within department.
- Recognize potential scheduling and resource conflicts for projects and provides recommendations to resolve.
What you will need-
Required:
- Bachelor’s Degree required, preferably in a Scientific Discipline and master of Science Degree in a Scientific Discipline preferred.
- minimum of 5 years of experience in healthcare products or medical devices required and minimum of 1 year of previous medical writing experience in a healthcare product or medical device industry required.
- Experience - 5 years - 7 years
- Experience with MEDDEV 2.7/1 Rev. 4 and EU Medical Device Regulation 2017/745 (MDR) compliant clinical evaluations preferred.
- Strong scientific and medical writing skills required.
- Must be able to think analytically, have the ability to interpret data from scientific literature and clinical studies and synthesize the results and in a clear, concise, and scientifically accurate manner in the clinical document.
Preferred:
- Ability to work effectively with cross-functional internal (Regulatory, Marketing, Research & Development) and external stakeholders (Physicians, CROs, Medical Staff, etc.) across multiple businesses.
- Knowledge in clinical operations, risk management, regulatory submissions and US and international guidelines preferred.
- Ability to apply ISO, FDA and related guidelines toward writing strategy and documentation preferred.