Paresh V.

About Paresh V.

18+ years’ strong industry experience in regulatory medical writing, principally for USFDA and EU submissions.# Managing high-end medical writing projects for NDA/MAA/BLA submissions.# Successfully led several CSR and CSP projects for Phase I-IV and Real-World Evidence studies (including PASS and REMS). Therapeutic areas: Oncology, Dermatology, Neurology, Endocrinology, Cardiology, Hematology, and Ophthalmology.# Authored and reviewed IB updates and amendments that were regularly assessed excellent by the clients. Therapeutic Areas: Oncology, Cardiovascular, Ophthalmology, Contraceptives, Endocrinology, Immunology, Diagnostics, and Infections and Infectious Diseases.# Effectively collaborated with clients for their NDA, MAA, or BLA submissions to author and review CTD Modules 2.4-2.7, 4, and 5 (including ISS and ISE), label updates (for global harmonization), and Type 2 Variation Filings/RFIs in accordance with Article 8(3), 10(a), 10(b), 10(c), 10(1), 10(4)(EU submissions), and 505b(1), 505b(2), and 505b(j)(USFDA submissions).# Wrote about 6 Briefing documents, 3 PIPs, and 2 ODDs.# Have been pivotally involved in receiving breakthrough therapy and fast track designations for a US-based pharma for their flagship product.# Hands-on experience in preparing DSURs, PBRERs, and ADCOs.# Adept in team leadership and mentoring; providing direction and guidance to project teams.# Actively participates in business development activities including pre-sales, efforts estimations, technical support, and client representation.# Proficiency in evaluation, interpretation, and presentation of scientific, clinical, pre-clinical, pharmacokinetic, and statistical data.# Performed bioanalysis for PK studies and developed numerous LC-MS/MS methods.# Published articles in international and national journals (Elsevier, Taylor & Francis, Lambert Publishing, Germany).

Experience

1. Associate Vice President, Medical Writing

   Accenture

   Mar 2022 — Present · IN

Education

• Dr.KNMIPER

  Bachelor of Pharmacy

  1995 — 1999

• Sai Nath University, Raanchi

  Doctor of Philosophy (Ph.D.)

  2011 — 2013

• JSS college of Pharmacy, Ooty, India

  Master of Pharmacy

  2002 — 2004