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    Protocol Writer

    Veeda Clinical Research Limited
    3-4 years
    Not Disclosed
    Ahmedabad
    10 June 25, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description: Protocol Writer

    Company: Veeda Clinical Research Limited
    Location: Ahmedabad, India
    Position: Protocol Writer
    Experience: 3-4 Years
    Qualification: B.Pharm / M.Pharm / Pharm D

    Company Overview

    Veeda Clinical Research Limited is a premier Contract Research Organization (CRO) specializing in clinical trial management and drug development services. We are dedicated to delivering high-quality solutions that adhere to global regulatory standards and drive advancements in healthcare.

    Job Summary

    As a Protocol Writer at Veeda Clinical Research Limited, you will be responsible for developing and reviewing clinical trial protocols. You will collaborate closely with cross-functional teams to ensure protocols are comprehensive, scientifically sound, and aligned with regulatory guidelines and sponsor requirements.

    Key Responsibilities

    • Protocol Development:

      • Draft and review clinical trial protocols according to regulatory guidelines, scientific principles, and sponsor specifications.
      • Ensure protocols are clear, concise, and accurately reflect study objectives, endpoints, and methodology.

    • Protocol Review and Approval:

      • Collaborate with internal stakeholders including clinical operations, medical affairs, and regulatory affairs to review and finalize protocols.
      • Incorporate feedback and revisions to ensure protocol integrity and alignment with study objectives.

    • Scientific and Regulatory Compliance:

      • Stay updated on ICH-GCP guidelines, regulatory requirements, and industry standards relevant to protocol development.
      • Ensure protocols adhere to ethical standards and regulatory expectations for clinical research.

    • Cross-functional Collaboration:

      • Work closely with study teams, including Clinical Research Associates (CRAs), Data Managers, and Biostatisticians, to align on protocol development and implementation.
      • Facilitate discussions and resolve protocol-related issues through effective communication and problem-solving.

    • Documentation and Reporting:

      • Maintain accurate documentation of protocol development processes, revisions, and approvals.
      • Prepare and contribute to regulatory submissions related to protocol amendments and updates.

    • Quality Assurance and Improvement:

      • Conduct quality checks on protocols to ensure accuracy, consistency, and compliance with internal SOPs and industry best practices.
      • Identify opportunities for protocol optimization and process improvements to enhance efficiency and quality.

    Qualifications and Skills

    • Educational Background:

      • Bachelor's or Master's degree in Pharmacy (B.Pharm / M.Pharm) or Pharm D.

    • Experience:

      • 3-4 years of experience in clinical research, with a focus on protocol writing and development within the pharmaceutical or CRO industry.
      • Proven track record of successfully developing clinical trial protocols and supporting regulatory submissions.

    • Technical Skills:

      • Strong understanding of clinical trial design, methodology, and regulatory requirements (ICH-GCP, FDA, EMA, etc.).
      • Excellent scientific writing skills with the ability to convey complex information clearly and concisely.

    • Communication and Collaboration:

      • Effective interpersonal skills with the ability to collaborate across multidisciplinary teams.
      • Proficiency in MS Office suite and familiarity with document management systems used in clinical research.

    • Attention to Detail:

      • Keen attention to detail and accuracy in protocol writing and documentation.
      • Ability to manage multiple projects and deadlines while maintaining high-quality standards.

    What We Offer

    • Competitive compensation package based on experience and qualifications.
    • Comprehensive benefits including healthcare coverage and professional development opportunities.
    • A dynamic and supportive work environment committed to scientific excellence and innovation in clinical research.

    How to Apply

    Interested candidates who meet the qualifications are encouraged to submit their resume and cover letter to careers@veedacr.com with the subject line "Application for Protocol Writer - Ahmedabad."

    Join Veeda Clinical Research Limited and contribute to shaping the future of clinical trials through impactful protocol development and adherence to global regulatory standards.

    Note: This job description serves as a general overview and may include additional responsibilities and qualifications as required by Veeda Clinical Research Limited.

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