Kabila B
Clinical Evidence I Medical Affairs I Medical Devices I AMWA Certified Medical Writer
- Role
- Lead Medical Writer (Sme) at HCLTech
- Location
- Chennai, IN
- LinkedIn followers
- 500 followers
About Kabila B
Possessing PharmD as a higher education and being a certified medical writer, meticulously demonstrate the competency in developing, reviewing, or updating end-to end clinical documentation for all classes of medical devices utilizing the clinical, scientific, and regulatory expertise on global regulations.
Experience
Lead Medical Writer (Sme)
Apr 2018 — Present · Chennai, IN
Develop and review the end-to-end clinical documentation of medical devices for regulatory compliance utilizing the clinical, scientific, and regulatory expertise on global regulations. Analyze the current medical and scientific trends in the clinical state of the art on a broad spectrum of specialized indications and techniques and propose methodologies to adapt to a complex and quickly evolving regulatory and scientific framework, especially for high-risk and innovative devices. Support the client in placing the new medical device on the market and putting it into service, acting as the portfolio\'s point of contact to support life cycle management or postproduction risk review activities as needed. Provide high-level technical and operational recommendations and support the client in addressing the review comments from Notified Bodies or Expert Panels. Provide continuous training and be responsible for building the capabilities to fulfill the project requirements.
Education
Sri Ramakrishna Matric Hr. Sec. School
Schooling
1990 — 2004
PSG College of pharmacy
Doctor of Pharmacy (PharmD), Clinical research
2009 — 2012
RVS College of Pharmaceutical Sciences
Bachelor of Pharmacy (B.Pharm.), Pharmaceutical Sciences
2004 — 2008
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