Priyanka Vemu
Hyderabad
Summary
Experienced and results-oriented Regulatory Medical Writer with over 5 years of expertise in clinical research, medical writing, and regulatory affairs, particularly in post-market surveillance for global markets (US and EU). Proven ability to prepare, review, and finalize complex regulatory documents including clinical evaluation reports, post-market surveillance plans, and post-market clinical follow-up reports (PMCF). Strong leadership and project management skills, with a demonstrated ability to collaborate cross-functionally to ensure compliance with FDA and EU regulatory requirements. Adept at interpreting and summarizing clinical, scientific, and statistical data to create clear, accurate, and impactful documents.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Principal Medical Writer
Criterion Edge Professional Services, Inc.
Hyderabad
06.2021 - Current
- Plan, prepare, and finalize regulatory documents required for post-market surveillance in compliance with US and EU regulations (FDA, EMA, MDR), including CERs, post-market surveillance plans, SSCPs, and PMCFs.
- Ensured adherence to MDR/MDD regulations to achieve CE marking for new devices and uphold CE certification for existing products
- Supported systemic literature reviews and Performance Evaluation Reports (PERs) and technical documentation for In Vitro Diagnostics (classes D, C, B, and A) in accordance with IVDR regulations, ensuring timely delivery within agreed deadlines
- Collaborated with cross-functional teams to develop and maintain technical documents, ensuring clarity and consistency in written materials, supporting regulatory compliance and product development
- Compiled and developed summary reports of clinical study results, tailored for submission to regulatory bodies like the FDA
- Conducted systematic literature searches in PubMed, Embase, Google scholar databases using PICO method and compile a systematic literature report for subject device and state of the art/competitor devices
- Guided product development teams on local regulatory requirements, resulting in 100% faster submission filing and compliance
- Improved efficiency and ensured timely market access
- Engaged with stakeholders throughout all phases of document development, ensuring clear and effective communication
- Collaborated with clinicians, clinical scientists and biostatisticians to interpret study results and accurately reflect in relevant documents
- Managed team of 10 members training on company's writing standards and procedures and international medical device regulations
- Developed comprehensive General Safety and Performance Requirements (GSPR) checklists for medical devices
- Maintained current knowledge of regulations and guidelines (e.g., MDCG, ICH, FDA), anticipating changes and opportunities, resulting in seamless compliance and proactive adaptation to regulatory environments
- Summarized key findings from preclinical and clinical data for regulatory submissions
Associate Research Analyst
Clarivate Analytics
TS, India
07.2018 - 12.2018
- To prepare high quality reviews, abstracts and reports of clinical trials and clinical data pertaining to drugs, biologicals, medical devices and updating appropriate drug records as well as clinical trial records in the database.
- Collaborated with cross-functional teams, including clinical researchers and regulatory professionals, to provide data driven insights for product development and market access strategies .
- Assisted in the preparation of technical reports and regulatory documents, ensuring accuracy and adherence to global regulatory standards.
- Interpreted and synthesized large volumes of clinical data from multiple sources to compile evidence-based summaries for regulatory submissions and internal stakeholders.
Associate Research Analyst
Thomson Reuters
TS, India
11.2013 - 01.2015
- To prepare high quality reviews, abstracts and reports of clinical trials and clinical data pertaining to drugs, biologicals, medical devices and updating appropriate drug records as well as clinical trial records in the database.
- Collaborated with cross-functional teams, including clinical researchers and regulatory professionals, to provide data driven insights for product development and market access strategies .
- Assisted in the preparation of technical reports and regulatory documents, ensuring accuracy and adherence to global regulatory standards.
- Interpreted and synthesized large volumes of clinical data from multiple sources to compile evidence-based summaries for regulatory submissions and internal stakeholders.
Education
Master of Pharmacology and Toxicology -
Kakatiya University
Telangana, India12-2012
Bachelor of Pharmacy -
Kakatiya University
Telangana, India01.2010
Skills
- Regulatory Document Writing (CER, SSCP, PMCF, PMS plans, and reports)
- Strong knowledge of FDA and EU MDR regulations (21 CFR 81482, Regulation EU 2017/745)
- Post-Market Surveillance & Post-Market Clinical Follow-Up
- Clinical Evaluation and Reporting
- Systematic Literature Reviews
- Project Management and Documentation Strategy
- Quality Assurance and Regulatory Compliance
- Quality Management System
- IVDR technical documentation
- ISO 10993: Medical Device Biocompatibility Testing
Certification
- ISO 14971: 2019 - Application of Risk Management to medical devices
Languages
- English
- Telugu
- Hindi
Publications
- Toxicokinetic and Tissue distribution studies of Mercury in an Ayurvedic preparation- Shila Sindur, 09/01/14
Timeline
Principal Medical Writer
Criterion Edge Professional Services, Inc.
06.2021 - Current
Associate Research Analyst
Clarivate Analytics
07.2018 - 12.2018
Associate Research Analyst
Thomson Reuters
11.2013 - 01.2015
Master of Pharmacology and Toxicology -
Kakatiya University
Bachelor of Pharmacy -
Kakatiya University
Similar Profiles
Katelyn FloodKatelyn Flood
Sponsorship Fulfillment at Professional Edge FishingSponsorship Fulfillment at Professional Edge Fishing
Erika BarronErika Barron
Industrial Hygienist III at Criterion Laboratories Inc.Industrial Hygienist III at Criterion Laboratories Inc.
Alessio GianniAlessio Gianni
Laboratory Analyst at Criterion Labs.Laboratory Analyst at Criterion Labs.