Dr. Pradnya Patil
Documentation Specialist / Regulatory Medical Writer / Project Coordinator / Project Management
Thane,MH
Summary
Experienced professional with 10+ years in project management, document quality control, and regulatory writing. Proven ability to manage end‑to‑end documentation processes, ensure compliance with international standards (ICH‑GCP, EMA, FDA), and deliver high‑quality outputs within tight timelines. Skilled at coordinating cross‑functional teams, conducting training, and collaborating with stakeholders across clinical, regulatory, and medical affairs. Hands‑on expertise with Veeva Vault, PleaseReview, TrackWise, SharePoint, Microsoft Office, Articulate, Inkling, CREDI, and Electronic Document Systems (EDS).
Overview
14
14
years of professional experience
3
3
Languages
Work History
Senior Medical Writer / Documentation Specialist
Tata Consultancy Services
11.2015 - Current
- Led end-to-end coordination for regulatory and business documentation: protocols, Clinical Study Reports, Investigator Brochures, narratives, and slide decks.
- Performed peer quality control and compliance reviews aligned with ICH‑GCP, EMA, and FDA standards.
- Managed SOP development and updates for Global Medical Affairs and Pharmacovigilance; supported deviation handling, and business continuity planning.
- Designed and delivered training programs and materials to improve team capability, and reduce QC findings.
- Maintained trackers and metrics; liaised with global stakeholders to ensure timely delivery and client satisfaction.
- Tools: Veeva Vault, PleaseReview, TrackWise, SharePoint, Electronic Document Systems, MS Office, Articulate, Inkling, CREDI.
Regulatory Medical Writer
Cognizant Technology Solutions, CTS
04.2014 - 10.2015
- Managed narrative writing projects from initiation to finalization; ensured consistency and regulatory compliance.
- Conducted therapeutic area training and collaborated with clinical and research teams.
Junior Regulatory Writer
Genelife Clinical Research
01.2013 - 04.2015
- Authored protocols, investigator brochures, informed consent forms, patient diaries, executive summaries, and NDAC presentations.
- Reviewed efficacy and safety data for SOP/GCP/ICH compliance; participated in client meetings to align timelines.
Clinical Research Coordinator
Amclin Life Sciences
09.2011 - 12.2012
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Education
Post Graduate Diploma in Clinical Research - Clinical Research
IcBio Center For Bioscience
Mumbai 04.2001 -
Bachelor in Homeopathic Medicine And Surgery (BHMS - Homeopathic Medicine
Rajiv Gandhi University of Health Sciences
Karnataka 04.2001 -
Skills
Communication skills: Clear written and verbal communicator; experienced in stakeholder engagement, client-facing updates, and cross‑functional collaboration
Organisational skills: Strong project coordination, time management, and ability to manage multiple deliverables under tight deadlines
Professional skills: Document drafting and review, regulatory writing, SOP development, training delivery, QC and compliance checks
Digital skills: Advanced user of Microsoft Office (Word, Excel, PowerPoint); hands‑on experience with Veeva Vault, PleaseReview, TrackWise, SharePoint, Articulate/Storyline, Inkling, CREDI, and Electronic Document Systems
Timeline
Senior Medical Writer / Documentation Specialist
Tata Consultancy Services
11.2015 - Current
Regulatory Medical Writer
Cognizant Technology Solutions, CTS
04.2014 - 10.2015
Junior Regulatory Writer
Genelife Clinical Research
01.2013 - 04.2015
Clinical Research Coordinator
Amclin Life Sciences
09.2011 - 12.2012
Post Graduate Diploma in Clinical Research - Clinical Research
IcBio Center For Bioscience
04.2001 -
Bachelor in Homeopathic Medicine And Surgery (BHMS - Homeopathic Medicine
Rajiv Gandhi University of Health Sciences
04.2001 -