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    Sr Medical Writer /Medical Writer 2 (Clinical Trial Transparency)

    Syneos Health
    2+ years
    Not Disclosed
    Gurugram
    10 March 9, 2025
    Job Description
    Job Type: Full Time Education: BA/BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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

    Senior Medical Writer / Medical Writer 2 (Clinical Trial Transparency)
    Updated: March 6, 2025
    Location: India-Asia Pacific - IND-Gurugram-DLF Downtown, India
    Job ID: 25001397-IND501

    Description:

    Senior Medical Writer

    Join Syneos Health and be part of a growing and evolving biopharmaceutical industry leader. Our team of 25,000+ employees worldwide works to improve patients’ lives. At Syneos Health, we believe every patient is more than a number—they are family, friends, and neighbors.

    Why Syneos Health?

    • Total Self Culture: We encourage authenticity and inclusivity, knowing that unique contributions make a difference.
    • Comprehensive Benefits: We offer total health coverage—physical, mental, and financial.
    • Diversity & Collaboration: We bring together diverse thoughts, backgrounds, and perspectives to create a workplace where everyone belongs.

    Job Summary:

    The Clinical Trial Disclosure team plays a crucial role in executing projects for Syneos global clients. The Senior Medical Writer processes complex scientific, medical, and technical information within high-performing teams.

    Skills & Experience:

    • Experience: 4-8 years as a medical writer, focusing on redactions/anonymization of clinical documents per EMA Policy 0070, Health Canada PRCI, EUCTR regulation, and final rule-NIH.
    • Regulatory Knowledge: Strong understanding of disclosure regulations and quality review processes.
    • Disclosure Documentation: Experience in preparing disclosure documents (Protocol Registration Form, Result Registration Form) for clinicaltrials.gov and other clinical registries.
    • Clinical Study Understanding: Ability to comprehend protocols and clinical study reports from a disclosure perspective.
    • Fundamental Knowledge: Strong grasp of clinical trial disclosure fundamentals.

    Job Responsibilities:

    1. Authoring & Quality Assurance:

    • Execute project-specific activities with high quality and within defined timelines.
    • Review, edit, and quality-check clinical study documents, regulatory submissions, and disclosure commitments.
    • Conduct systematic quality control checks using pre-specified checklists.
    • Perform detailed analyses on processes and outputs.
    • Ensure adherence to client processes.

    2. Additional Responsibilities:

    • Complete internal and client-specific training.
    • Assist in mentoring and training team members as required.

    Qualification Requirements:

    • Education: Minimum graduate degree in life sciences.
    • Regulatory Knowledge: Familiarity with regulatory requirements and clinical development processes.
    • Technical Skills: Proficiency in MS Word, PowerPoint, and Excel.
    • Core Competencies:
      • Strong analytical skills with scientific and clinical data.
      • Professionalism and ownership of assigned work.
      • High attention to detail and commitment to quality.
      • Enthusiasm, proactivity, and teamwork.
      • Ability to build client relationships.

    Preferred Qualifications:

    • Degree: Bachelor of Science (preferred) or Bachelor of Arts (Social Sciences, English, Communications).
    • Grammar & Guidelines: Strong knowledge of English grammar, FDA & ICH regulations, and AMA style guide.
    • Independence & Leadership: Effective presentation, proofreading, and interpersonal skills.
    • Software Proficiency: Strong command of Word, Excel, PowerPoint, email, and the internet.
    • Clinical Research Knowledge: Familiarity with clinical research principles and data interpretation.

    About Syneos Health:

    Over the past five years, Syneos Health has worked on:

    • 94% of all Novel FDA Approved Drugs.
    • 95% of EMA Authorized Products.
    • 200+ studies across 73,000 sites and 675,000+ trial patients.

    At Syneos Health, we challenge the status quo and thrive in a competitive, ever-changing environment. Learn more about Syneos Health and be part of a team that makes a difference.

    Additional Information:

    • Responsibilities listed in this job description are not exhaustive.
    • Syneos Health may assign additional tasks and job responsibilities as needed.
    • Equivalent experience, skills, or education may be considered for qualification.
    • Syneos Health complies with the Americans with Disabilities Act and provides reasonable accommodations where necessary.

     

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