Suraj Ghonge

About Suraj Ghonge

A dedicated and results-driven Medical Writer with over 5 years and 4 months of experience in the clinical research industry. Currently serving as a Senior Process Associate at Tata Consultancy Services (TCS), I specialize in creating, reviewing, and editing high-quality clinical documents for regulatory submissions. My expertise includes authoring clinical Protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), Investigators\' Brochures (IBs), and safety documents such as Six-Monthly SUSAR Reports (SSRs). I am skilled at collaborating with cross-functional teams to ensure regulatory compliance while maintaining high standards of document quality.In addition to my medical writing expertise, I have experience working with various software tools such as Veeva Vault RIM, IDM, MS Word, MS Excel, and MS PowerPoint. My work involves developing and reviewing critical clinical and regulatory documents like Protocol and Amendment summaries, ensuring they meet stringent guidelines for timely submission to regulatory bodies like EudraCT and ClinicalTrials.gov. I also oversee regulatory pre-publishing activities to ensure documents meet technical publishing standards using tools like Adobe, LIQUENT InSight, Veeva Vault RIM, IDM D2, and ISI Toolbox.During my tenure at Accutest Research Laboratories, I coordinated project-related information, performed literature searches, and conducted feasibility checks for regulatory submissions. I also played a key role in preparing essential documents for regulatory approval, including Protocol, ICF, and CSR writing. My interaction with regulatory agencies, including IEC, IRB and DCGI, ensured smooth approval processes.My commitment to continuous improvement and efficiency, coupled with strong communication and collaboration skills, has earned me recognition, including the Employee of the Month award in July 2021. With an M-Pharm degree in Pharmacology from Amravati University, I possess a solid foundation in clinical operations and bio-analytical methods development with validation for the estimation of Sulfamoyl Loop Diuretic Bumetanide derivative in human plasma by using LC-MS/MS.I am passionate about contributing to the success of clinical research and ensuring the timely and accurate delivery of high-quality regulatory documents. Eager to learn and grow in this dynamic field, I thrive on supporting teams to achieve their goals and meet regulatory standards.

Experience

1. Content Manager

   Accenture

   Jun 2025 — Present

   Design and develop digital marketing ads and promotional content for Medical Affairs. Deliver business solutions in medical publications, education, medical grants, and advocacy. Support regulatory review and approval processes for pharmaceutical drugs. Perform publishing and quality control tasks on submission components on VeevaPromomats tool. Use data, technology, and content services to improve marketing performance. Drive customer engagement and media growth initiatives. Solve complex marketing and operational challenges with minimal supervision. Interact with internal teams and occasionally with clients or management. May lead or contribute individually to small-scale projects or teams. Work in rotational shifts as required.

Education

• Msbte

  Associate of Pharmacy

• P. Wadhwani College of Phramacy, Yavatmal

  Bachelor of Pharmacy - (B-Pharm), Pharmaceutical Sciences

• Amravati University

  Master of Pharmacy, Pharmacology

• Amravati University

  Bachelor of Pharmacy

• Lokmanya Tilak Mahavidhylay, Wani, Yavatmal.

  12th, Science

• P. Wadhwani College of Pharmacy, Yavatmal

  Master of Pharmacy - (M-Pharm), Pharmacology

• Institute of Pharmacy, Wani, Yavatmal

  Diploma in Pharmacy (D-Pharm), Pharmaceutical Sciences