Senior Medical Writer

Stryker; Gurugram District; On-site; INR 600,000 - 900,000; Full time

Job summary

Stryker is a global leader in medical technologies. As a Medical Writer, you will work with Regulatory, Clinical, Quality and Marketing to prepare submission-ready clinical documents such as clinical evaluation reports and CERs.

You will compile evidence from trials, literature and post-market data, support EU MDR submissions, coordinate reviews, and ensure timely approvals while developing procedures and style guides.

Qualifications

• Minimum 2–5 years in healthcare products or medical devices.
• Experience in medical writing for healthcare products or medical devices.
• Familiar with MEDDEV 2.7/1 Rev.4 and EU Medical Device Regulation 2017/745 (MDR).
• Strong scientific and medical writing skills.

Responsibilities

• Collaborate with Regulatory, Clinical, Quality and Marketing to prepare submission-ready clinical documents (CERs, CECs, clinical study documents).
• Compile clinical evidence from trials, literature reviews, and post-market data for EU‑MDR submissions and CERs.
• Develop and maintain Clinical Evaluation Reports (CERs) for new medical devices to support registrations.
• Coordinate literature searches and synthesize information for regulatory documents.
• Lead document revisions and coordinate reviews to secure timely approvals.
• Serve as a subject matter expert within the department and support procedures and style guides.

Skills

Scientific writing

Cross-functional collaboration

Regulatory knowledge

EU MDR / MEDDEV familiarity

Data synthesis

Attention to detail

Education

Bachelor’s Degree in Science

Master of Science in a Scientific Discipline

Job description

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.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.