Senior Medical Writer - Clinical and Regulatory Documentation

Staff Engineer- Medical Writer

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.

Travel Percentage: 10%

Experience Level

Senior Level