Medical Writer - Clinical and Regulatory Documentation Specialist

Medical Writer

Work Flexibility: Hybrid

What you will do :

• As a Medical Writer, 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 and 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 and assist in the development of internal procedures, templates and style guides.

• 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 skills-

• Bachelor’s Degree required, preferably in a Scientific Discipline and Master of Science Degree in a Scientific Discipline preferred.

• Experience - 2 years - 5 years

• minimum of 2 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 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.

Preferred skills-

• 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.

• 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

Mid Level