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    Medical Writer Ii

    Parexel
    2+ years
    Not Disclosed
    Remote
    10 March 19, 2025
    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, 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

    About This Role

    As a Medical Writer at Parexel, you will be responsible for managing scheduled and unscheduled aggregate reports, including Periodic Safety Reports (PSRs), Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and other related documents. You will also play a key role in preparing Clinical Study Report (CSR) narratives, signal detection and management, and ensuring compliance with regulatory standards. This role requires a deep understanding of pharmacovigilance and regulatory reporting, excellent communication and organizational skills, and a strong ability to manage multiple priorities in a fast-paced environment.

    Key Responsibilities:

    Aggregate Reports:

    • Prepare, update, and merge various reports, including PSRs, PBRERs, DSURs, and more, ensuring compliance with client requirements and SOPs.
    • Conduct critical literature reviews, particularly focusing on background epidemiology for inclusion in drug safety reports and RMPs.
    • Generate line listings, identify discrepancies, and resolve issues to ensure report integrity and consistency.
    • Perform quality checks and internal reviews to confirm the accuracy and completeness of safety reports, including PBRERs and RMPs.
    • Distribute final reports to stakeholders and submit to health authorities in accordance with regulatory requirements.
    • Coordinate and attend meetings, draft agendas, track action items, and ensure follow-up on open issues.

    Clinical Study Report Narratives:

    • Liaise with the Study Management Team (SMT) to develop narrative templates and review narrative drafts.
    • Prepare clear and accurate narratives from clinical and safety databases, ensuring medical accuracy and adherence to client and Parexel guidelines.
    • Conduct quality checks and final formatting of narratives to ensure high-quality deliverables.

    Signal Detection & Management:

    • Perform signal detection and analysis (qualitative and quantitative) using data from various sources such as regulatory authority databases, client databases, and literature.
    • Lead the end-to-end signal management process, including tracking, assessment, data analysis, and presenting findings in collaboration with the Global Safety Organization (GSO).
    • Conduct signal detection and evaluation activities per SOPs and regulatory guidelines.

    General Responsibilities:

    • Maintain a comprehensive understanding of the adverse event safety profile of assigned drugs and related labeling documents.
    • Stay up-to-date on global regulatory reporting obligations and ensure compliance with internal and external timelines.
    • Provide training and mentorship to new team members as needed.
    • Serve as the primary client contact, ensuring high-quality work and timely issue resolution.
    • Participate in departmental and interdepartmental process improvements and training initiatives.

    Skills & Qualifications:

    • Analytical & Problem-Solving Skills: Ability to evaluate data, identify trends, and draw conclusions independently.
    • Excellent Communication Skills: Strong verbal and written communication skills, ensuring clarity and precision in all documentation.
    • Team Collaboration: Ability to work collaboratively with cross-functional teams and clients.
    • Organizational Skills: Strong ability to manage multiple tasks and prioritize workload with attention to detail.
    • Medical Writing Expertise: Capability to write clear, concise, and accurate medical content, particularly clinical and safety reports.
    • Fluency in English: Proficiency in both written and spoken English.
    • Technical Skills: Proficient with MS Office (Word/Excel/PowerPoint) and other relevant software applications.

    Knowledge & Experience:

    • Regulatory/Pharmacovigilance Experience: Experience in regulatory reporting or pharmacovigilance is highly desirable.
    • Medical Terminology: Strong understanding of medical terminology and concepts.
    • Educational Background: A degree in Life Sciences, Health, Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.), or a medical degree (Medicine, Dentistry, Physiotherapy, Nursing) is required. A degree involving patient exposure in a hospital-based environment is an advantage.

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