Senior Medical Writer (Gurugram)

Senior Medical Writer (Gurugram)

19 Aug
|
Stryker
|
Gurugram

19 Aug

Stryker

Gurugram

Why join Stryker?

Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description

We are excited to be named one of the World’s Best Workplaces by Fortune Magazine

We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.

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 current 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 do

📌 Senior Medical Writer (Gurugram)
🏢 Stryker
📍 Gurugram

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