Bhavani prasanna Kandipalli
Medical Writer HCL Tech
Rajahmundry
Summary
Accomplished Medical Writer with a proven track record at HCL Tech, adept in aligning resources and exceeding communication objectives through mastery in medical writing and ISO 13485. Excelled in editing, proofreading, and delivering high-quality regulatory documents, demonstrating exceptional attention to detail and stakeholder management skills.
Overview
3
3
years of professional experience
5
5
Languages
Work History
Technical Writer
Cyient Ltd
06.2024 - Current
Medical Writer
HCL Tech
11.2021 - 05.2024
- Negotiated on behalf of medical writing to align resources, timelines, and expectations.
- Combined thorough understanding of therapeutic area with product strategy to meet communication objectives on assigned projects.
- Worked and drafted PMS, PSUR, CSR and CER reports and delivered with quality.
- Proofread copy written by colleagues to correct spellings, punctuation, and grammar with specified tools.
- Delivered knowledge sharing sessions to the freshers.
- Supported for CER project in Proofreading the documents.
- Worked in COSIMA tool for the IFU Files in siemens by using XML.
- Translation proof reader activity and language proof reading.
- EU IVDD and IVDR transition.EUDAMED statement of medical device for transparency and traceability.
- Edited and proofread technical documents for accuracy and consistency.
- Medical device IFU including failure mode effect analysis(FMEA), MDR submission to global regulatory bodies US FDA, EU MDR, Health canada.
- Managed stakeholder expectations through regular presentations, status reports and issue resolution discussions during the course of projects.
Education
Bachelor of Science - B Pharmacy
Aditya College of Pharmacy
Kakinada, India 04.2001 -
Skills
- Medical writting
- ISO 13485 , ISO 14971
- ICH Guidelines
- MDR & DHF
- Proof reading
- Translation proof reading
- CAPA
- IEC 60601, IEC 62366
- EU IVDR
- MS Excel
- Power point presentations
- MS Word
- Cosima tool, Trackwise
Timeline
Technical Writer
Cyient Ltd
06.2024 - Current
Medical Writer
HCL Tech
11.2021 - 05.2024
Bachelor of Science - B Pharmacy
Aditya College of Pharmacy
04.2001 -
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