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    Medical Writer I

    Parexel
    1-3 years years
    Preffered by Company
    Remote
    10 July 15, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/M.Pharm/PharmD 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

    Job Opening: Medical Writer I

     

    Location: India (Remote)

    Company: Parexel
     

    Overview

    About this Role:
    As a Medical Writer at Parexel, you will leverage your strong scientific knowledge, writing skills, and patient focus to effectively communicate complex scientific data to various stakeholders, including regulatory agencies, medical professionals, and the general public. You will collaborate within cross-functional teams to develop a wide range of clinical research documents, such as model informed consent forms, clinical study reports, pharmacovigilance documents, and more.

    Our Culture:
    We foster a culture of inclusivity, collaboration, and support that empowers our employees to make a meaningful impact on people's lives. We offer continuous learning opportunities, from being mentored to job shadowing, job rotation, and stretch assignments, as well as becoming a mentor or leading a team. Your development and promotion are based on global standards and your personal development plan.

    Success Profile

    Essential Soft Skills and Traits:

    • Adaptable
    • Communicator
    • Consistent
    • Deadline-oriented
    • Detail-oriented
    • Insightful

    About This Role

    Job Purpose:
    You will be responsible for managing scheduled and unscheduled aggregate reports, including but not limited to Periodic Safety Reports (PSRs), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United States Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Annual Risk-Benefit Evaluation (ARBE) reports, Risk Management Plans (RMPs), Safety statements, Health Hazard Evaluations (HHEs), Drug Safety Reports (DSRs), Clinical Overviews (COs), Safety Evaluation Reports (SERs), and Investigational New Drug Annual Reports (INDARs). You will also prepare documents comparing local and global labeling documents and checking International Non-proprietary names (INNs) for inclusion in PSRs as per client requirements.

    Key Accountabilities:

    1. Aggregate Reports:

      • Prepare/update/merge RMPs/Company Core-RMPs (CC-RMPs)
      • Manage scheduled and unscheduled aggregate reports
      • Conduct critical appraisal and systematic review of literature for inclusion in safety reports and RMPs
      • Generate Line Listings for submissions and identify discrepancies
      • Ensure high quality and consistency across documents

    2. Clinical Study Report Narratives:

      • Prepare clear and accurate narratives based on Clinical and Safety Database outputs
      • Perform quality checks on narratives and assist in compiling narrative deliverables

    3. Signal Detection and Management:

      • Perform signal detection review and analysis from various sources
      • Manage the end-to-end signal management process

    4. General:

      • Maintain knowledge of adverse event safety profiles, labeling documents, client guidelines, and global safety regulations
      • Organize workload to ensure compliance with timelines for adverse event reporting
      • Mentor new recruits and attend training sessions
      • Prepare for audits and inspections

    Skills

    • Analytical and problem-solving skills
    • Excellent interpersonal and communication skills
    • Organizational and prioritization skills
    • Ability to work collaboratively in a team environment
    • Client-focused approach
    • Ability to evaluate data and draw conclusions independently
    • Flexibility with work assignments and new learning
    • Proficiency with computer applications, especially MS Office
    • Ability to write clear, accurate medical text

    Knowledge and Experience

    • Experience in Regulatory/Pharmacovigilance or related field is desirable
    • Good knowledge of medical terminologies

    Education

    • A university degree in life sciences/health or biomedical sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.)
    • A degree in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing is an advantage

     

    Apply Now: Please visit Parexel Careers for more information and to submit your application. 

    Link: https://jobs.parexel.com/en/job/remote/medical-writer-i/877/67563645616

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