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    Medical Writer Ii

    Parexel
    6+ years
    Preffered by Company
    Hyderabad
    10 Sept. 3, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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

    Position: Senior Medical Writer

    Role Overview:

    As a Senior Medical Writer at Parexel, you will utilize your extensive scientific knowledge and writing skills to effectively communicate complex clinical research data to various stakeholders, including regulatory agencies, medical professionals, and the public. This role involves collaborating with cross-functional teams to develop a range of clinical research documents, such as informed consent forms, clinical study reports, pharmacovigilance documents, and more. You will also drive process improvements, provide technical mentoring, and support the Medical Writing Services management with client interactions and proposal development.

    Key Responsibilities:

    • Document Management:

      • Prepare and manage a variety of aggregate reports including Periodic Safety Reports (PSRs), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and others.
      • Develop and update Risk Management Plans (RMPs), Health Hazard Evaluations (HHEs), and other safety-related documents.
      • Generate line listings, create drug lists/folders, and handle regulatory submissions.

    • Clinical Study Report Narratives:

      • Coordinate with study management teams to develop and review narrative templates and categories.
      • Draft clear and accurate narratives from clinical and safety database outputs, ensuring alignment with client and Parexel standards.
      • Perform quality checks on narratives and ensure comprehensive final quality control.

    • Signal Detection and Management:

      • Conduct signal detection reviews and analyses from various data sources.
      • Manage the end-to-end signal management process, including tracking, assessment, and presentation of findings.

    • General Responsibilities:

      • Maintain knowledge of assigned drug safety profiles, client guidelines, and international regulations.
      • Ensure compliance with internal and regulatory timelines for adverse event reporting.
      • Participate in training, audits, and process improvement initiatives.
      • Mentor junior team members and manage client interactions effectively.

    Qualifications:

    • Experience:

      • Minimum of 6 years in regulatory medical writing, with experience across various therapeutic areas (e.g., vaccines, oncology, cardiovascular).
      • Experience with clinical trial documentation, aggregate reports, and safety reports.

    • Education:

      • Bachelor’s or advanced degree in life sciences, healthcare, or a related field. Degrees in Medicine, Dentistry, Physiotherapy, or Experimental Medicine are advantageous.

    • Skills:

      • Strong analytical, problem-solving, and communication skills.
      • Ability to work independently, manage multiple tasks, and meet deadlines.
      • Proficiency in Microsoft Office Suite and familiarity with web-based applications.

    • Personal Traits:

      • Detail-oriented, adaptable, and consistent.
      • Insightful with a client-focused approach.
      • Ability to collaborate effectively in a team environment and handle feedback constructively.

    Why Join Us?

    At Parexel, we are committed to fostering a culture of inclusivity and collaboration. We provide continuous learning opportunities through mentoring, job shadowing, job rotation, and leadership roles. Your career development and advancement are guided by global standards and your personal development plan. Join us to make a meaningful impact on patients' lives and grow within a supportive and dynamic environment.

    Ready to Apply?

    If you have the skills and experience to excel in this role and are passionate about advancing clinical research, we encourage you to apply and become a key part of our team at Parexel.

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