Senior Medical Writer

Stryker Corporation; India; On-site; Confidential; Full time

Job summary

Stryker Corporation in India seeks a Medical Writer to produce submission-ready clinical documents and collaborate with Regulatory, Clinical, Quality and Marketing teams to deliver CERs, clinical study reports and post‑market follow‑up documents. The role requires a scientific degree, 2–5 years in healthcare products or medical devices, and at least 1 year of medical writing experience, with familiarity of MEDDEV 2.7/1 Rev.

4 and EU MDR 2017/745.

Qualifications

• Bachelor's degree in a scientific discipline is required.
• 2–5 years minimum of healthcare products or medical devices experience; at least 1 year in medical writing is required.
• Experience with MEDDEV 2.7/1 Rev. 4 and EU MDR 2017/745 clinical evaluations preferred.
• Strong scientific and medical writing skills are essential.

Responsibilities

• Prepare and coordinate Clinical Evaluation Reports (CERs) and other regulatory documents.
• Synthesize evidence from literature, trials, and post-market data for EU submissions.
• Collaborate with Regulatory, Clinical, Quality and Marketing teams on document strategies.
• Lead review processes and resolve content questions to obtain timely approvals.

Skills

Medical writing

Scientific writing

Analytical thinking

Cross-functional collaboration

Education

Bachelor's degree in scientific discipline

Master of Science in scientific discipline (preferred)

Job description

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 assists 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% Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.