Vinaya
Senior Medical Writer| Medical Content Writer| Regulatory Writer| Clinical Evaluation| Drugs & Medical Devices |Medico-Marketing & Physician Engagement
- Role
- Senior Medical Writer at Tata Elxsi
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Vinaya
Medical Writing professional with 9 years of diversified experience across scientific…
Experience
Senior Medical Writer
Oct 2021 — Present · Pune, IN
Medical Writing Expertise • Independently authored and delivered EU MDR-compliant documents (CERs, CEPs, SSCPs, PSUR, PMCF plans and reports, CRF) in line with MedDev 2.7/1 Rev. 4 and EU MDR requirements. • Conducted clinical evaluations and prepared regulatory supporting documents for submissions. • Performed literature reviews in assigned therapeutic areas and provided scientific input across cross-functional teams. Analyzed complaint-handling data (Excel) including CAPAs, SCARs, and FSCAs to support PMS, risk management, and device safety reporting.• Streamlined reviewer feedback integration to efficiently finalize clinical and regulatory deliverables.• Mentored and provided technical guidance to junior and new medical writers, enhancing team performance and document quality.SQA & Audit Expertise• Performed comprehensive QC checks (copyediting, proofreading, data verification against TFLs) to ensure accuracy, consistency, and regulatory compliance.• Supported Software Quality Assurance (SQA) activities and served as an audit observer, maintaining documentation integrity and regulatory readiness.• Assisted project managers in achieving monthly SQA metrics and compliance goals.• Analyzed complaints data to identify trends and support risk assessment initiatives.
Education
Shivaji University
Msc
2012 — 2014
Sangmeshwar college of Science
12th
2007 — 2009
Little Flower High School
10th
1997 — 2007
Symbiosis Centre for Distance Learning
Diploma in Clinical research
2021 — 2022
VGS college of Biotechnology
Bsc
2009 — 2012
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