Sheetal Shetye
Mumbai,MH
Summary
Accomplished medical writing professional with extensive experience at Tata Consultancy Services, excelling in project delivery, and regulatory compliance. Proven track record in authoring high-quality clinical documents and leading cross-functional teams. Skilled in audit management and stakeholder communication, consistently achieving excellence in quality metrics and project outcomes.
Overview
22
22
years of professional experience
Work History
Project Delivery Manager / Senior Medical Writer
Tata Consultancy Services
07.2020 - Current
- Led cross-functional teams in Medical Writing, Quality Review, Disclosure, Clinical Narratives, Regulatory Affairs, Audit Management, Document Management, and Training Administration.
- Managed resource planning, performance evaluations, training initiatives, and overall project delivery.
- Ensured compliance with quality metrics, KPIs, SOPs, and regulatory standards.
- Collaborated with global stakeholders to facilitate seamless project execution.
- Authored Phase I–II Clinical Study Reports, Interim Reports, Protocols, and FDA Assessment Aids.
- Developed Clinical Trial Registry summaries and plain-language summaries for medical devices.
- Compiled IND and NDA modules while supporting automation initiatives in various workflows.
- Conducted regulatory document redaction and submitted protocol disclosures on CT.gov.
Assistant Medical Advisor
Charak Pharma Pvt. Ltd.
09.2007 - 07.2010
- Conducted medico-marketing activities and scientific communication.
- Initiated and monitored clinical trials; authored publications.
- Prepared CME slide decks and therapeutic area booklets.
- Provided scientific support to Product Management Teams.
- Published one international paper for M2-Tone.
Medical Writer
HansaMedcell
01.2007 - 08.2007
- Developed CME materials, LBLs, promotional booklets, and CDs.
- Provided scientific insights for pharmaceutical product promotion.
- Worked with brands including GSK, Novartis, Bristol Myers, Wallace.
- R.K. Swamy BBDO Pvt. Ltd.
Medical Writer
Oxygen Healthcare Communications Pvt. Ltd.
01.2006 - 12.2006
- Prepared CME slides, product manuals, and promotional materials.
- Supported creation of visual aids and audio-visual scripts.
- Developed website content and scientific presentations.
- Worked with multiple pharma clients: GSK, Novartis, Abbott, Aventis, Cipla, Wallace.
Medical Facilitator
Chandra Bhagat Pharma Pvt. Ltd.
01.2004 - 12.2004
- Supported sales teams with scientific data and product information.
- Created product manuals across cardiovascular, oncology, gynecology, anesthetic, orthopedic, and antibiotic therapies.
- Authored and edited company newsletters.
General Practitioner
Andheri
Registrar
Podar Hospital
House Officer
Podar Hospital
Education
PG Diploma - Clinical Research
Bombay College of Pharmacy
Mumbai01.2009
PG Diploma - Pharma Business Management
MET College
Mumbai01.2004
B.A.M.S. -
Sion Ayurvedic College
Mumbai01.1993
HSC -
Parle College
Mumbai01.1989
SSC -
L.V.M School
Mahim01.1987
Skills
- Medical & Regulatory Writing
- Clinical Research Documentation
- Project & Delivery Management
- Quality Review & Compliance
- Audit Management
- Disclosure & Transparency (CTgov)
- Team Leadership & Training
- SOP & Process Optimization
- Content & Template Library Development
- Stakeholder & Client Communication
- MS Office (Advanced)
- Medical Writing Tools & Documentation Systems
- Visio Workflow Design
- Regulatory document preparation
- Clinical trial management
- Medical writing
Accomplishments
10× R&R Awards for consistent high performance.
Timeline
Project Delivery Manager / Senior Medical Writer
Tata Consultancy Services
07.2020 - Current
Assistant Medical Advisor
Charak Pharma Pvt. Ltd.
09.2007 - 07.2010
Medical Writer
HansaMedcell
01.2007 - 08.2007
Medical Writer
Oxygen Healthcare Communications Pvt. Ltd.
01.2006 - 12.2006
Medical Facilitator
Chandra Bhagat Pharma Pvt. Ltd.
01.2004 - 12.2004
General Practitioner
Registrar
House Officer
PG Diploma - Clinical Research
Bombay College of Pharmacy
PG Diploma - Pharma Business Management
MET College
B.A.M.S. -
Sion Ayurvedic College
HSC -
Parle College
SSC -
L.V.M School