Dharmendra Kumar

About Dharmendra Kumar

Educational Background:M.S. in Pharma from NIPER, Hajipur.Bachelor\'s in Pharma from GGU, Bilaspur.Current Role: Scientific Writer 2 at Bristol Myers Squibb (June 2024 - Present)i) Author Clinical Study Protocols and Protocol Amendments, including diverse types such as interventional and epidemiological protocols.Collaborate with stakeholders and SMEs to ensure protocol development aligns with style guides and ICH guidelines.Organize and lead kick-off meetings, manage the Protocol Review Committee (PRC) process, and oversee protocol approval and finalization.ii) Write Clinical Study Reports (CSRs) in various formats, including interim, primary, addenda, and errata, ensuring regulatory compliance.Previous Roles:Medical Writer 1 at Fortrea (formerly Labcorp/Covance)(March 2018 - May 2024)Managed the end-to-end development of CSRs, following style guides and ICH guidelines.Engaged in direct communication with clients and sponsors for requirements gathering.Organized kick-off meetings, reviewed TFL data, and managed timelines from start to sign-off.Developed patient narratives using CIOMS guidelines and wrote Protocol Lay Summary Synopses.Participated in internal learning activities, delivering presentations on study insights.Senior Associate Medical Writer at Kinapse India (October 2015 - March 2018)Specialized in Clinical Trial Disclosures and Transparency Documents for Protocols and CSRs.Registered and managed protocols and results in regulatory databases, such as Clinicaltrials.gov and EudraCT.Edited and reviewed disclosure plans and datasets, ensuring compliance with regulatory guidelines.Interacted directly with study teams and clients to develop and maintain regulatory documents.Key Competencies:Strong commitment to quality, compliance, and stakeholder communication.Proven ability to manage complex medical writing projects efficiently.Versatile experience across clinical research documentation.Throughout my career, I have successfully completed numerous complex medical writing projects, showcasing my dedication to quality and effective communication, making me a valuable asset in medical writing.

Experience

1. Scientific Writer - Ii

   百时美施贵宝

   Jun 2024 — Present · Hyderabad, IN

   Scientific Writer – 2 at Bristol Myers Squibb (BMS)- Lead strategy, coordination, and authoring of clear, concise regulatory documents for global submissions and approvals- Collaborate with cross-functional teams to integrate scientific, medical, and regulatory insights, ensuring high-quality documents for product development and life cycle management- Author and coordinate Clinical Study Reports (CSR), Investigator’s Brochures (IB), and a range of Clinical Study Protocols (original, amendments, interventional, non-interventional, country-specific, and epidemiology)- Prepare protocol amendments in response to regulatory authority queries, including EU/UK Requests for Information (RFI), ensuring updates are aligned with regulatory requirements and BMS responses- Apply strategic and lean writing principles to create fit-for-purpose documents that meet regulatory standards and business objectives- Work closely with clinical, regulatory, and medical stakeholders to gather and integrate data and feedback- Manage timelines for all document components, ensuring timely delivery and high quality- Maintain document templates and shells, ensuring compliance with internal processes and external guidelines (FDA, EMA, ICH)- Oversee document review, resolving issues and inconsistencies to ensure high-quality submissions- Review and edit documents for scientific accuracy, clarity, and regulatory compliance- Stay current with therapeutic areas, regulatory guidelines, and BMS processes, with expertise in neuroscience, oncology, and other areas- Utilize advanced AI tools (ChatGPT, Copilot) to enhance document quality and reduce creation timelines, supporting organizational goals- Certified in AI technologies for regulatory writing, including CSRs, protocols, and slide decks- Proficient in Veeva Vault and CARA for authoring, reviewing, submitting, and managing documentation.

Education

• Guru Ghasidas University

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

  2008 — 2012

• Guru Ghasidas University

  Bachelor of Pharmacy - BPharm, Pharmacy

• National Institute of Pharmaceutical Education and Research

  Master of Science (MS), Pharmaceutical Biotechnology

  2012 — 2014

• Govt HS School Bhatgaon

  Higher Secondary, Biology

  2004 — 2005

Skills

• Scientific Writing
• Thesis Writing
• Molecular Cloning
• Eu Pas (Encepp)
• Nano-Biotechnology
• Regulatory Writing
• Medical Writing
• Poster Presentations
• Powerpoint Presentations
• Eudract
• Clinical Trial Application (Cta)
• Abstract Writing
• Molecular Biology
• Vctr
• Scientific Publications
• Clinicaltrials.gov
• Biotechnology
• Manuscript Development
• Protocol, Synopsis, Clinical Study Reports (Csr)
• Pharmacm
• Clinical Research
• Medical Coding
• Polymerase Chain Reaction (Pcr)
• Clinical Trial Disclosure/Transparency
• Pharmacology
• Cancer Research