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    Associate Manager, Safety Medical Writing

    Parexel
    2+ years
    Not Disclosed
    India
    10 Sept. 5, 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, 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

    Role: Associate Manager, Safety Services

    Job Purpose:

    The Associate Manager, Safety Services (SS) is tasked with overseeing the execution of aggregate and allied safety report writing, Clinical Study Report (CSR) narratives, and Signal detection and management. This role includes project and resource management responsibilities and, when applicable, line management of safety report writing or CSR narratives staff. The Associate Manager may also assist in sales processes by engaging in client interactions, contributing to proposals, and reviewing contracts.

    Key Accountabilities:

    • Line Management and General Management:

      • Supervise and mentor staff, handling all aspects of personnel management, including hiring, training, performance evaluations, and professional development.
      • Ensure adherence to departmental procedures, health authority regulations, and quality standards.
      • Manage performance, address low performance through coaching or performance improvement plans, and manage team morale and motivation.
      • Attend and chair management meetings, authorize expenses, invoices, and purchase orders as needed.

    • Client Liaison/Service:

      • Build and maintain strong client relationships to ensure satisfaction and confidence in services.
      • Implement performance measures and feedback systems to optimize service delivery.
      • Contribute to proposal generation and business development by providing strategic insights and attending meetings as required.

    • Project Management:

      • Set clear objectives for team members and monitor project progress.
      • Communicate project scope, client expectations, and timelines effectively.
      • Provide leadership and strategic planning, adjusting as necessary to meet project goals.
      • Monitor project performance and ensure integrity, capturing key learnings from each project.

    • Subject Matter Expertise and Process Improvement:

      • Contribute to process development and improvement by overseeing budgeting, financial monitoring, and adherence to SOPs.
      • Analyze work efficiency and identify areas for improvement.
      • Provide guidance on safety report writing guidelines and attend audits as needed.

    • Document Writing and Consultancy:

      • Prepare, develop, and finalize aggregate and allied safety reports or CSR narratives with minimal supervision.
      • Advise on regulatory issues related to safety reports and CSR narratives, adhering to ICH, GVP, FDA, EMA, and other guidelines.

    • Signal Detection and Management:

      • Conduct qualitative and quantitative signal detection reviews and manage the end-to-end signal management process.
      • Collaborate with the Global Safety Office (GSO) for signal detection and evaluation activities.

    • Quality Control:

      • Ensure the delivery of high-quality reports that comply with regulatory guidelines and SOPs.
      • Provide technical leadership and ensure adherence to project requirements.

    • Training and Compliance:

      • Stay updated on regulatory changes and industry trends.
      • Develop and present training materials to enhance writing quality and project management skills.
      • Mentor staff and provide training based on new knowledge and technical advancements.

    • General Responsibilities:

      • Maintain a positive and results-oriented work environment, fostering teamwork and open communication.
      • Provide coverage in the absence of other SS management and perform additional senior-level tasks as required.

    Skills:

    • Interpersonal and Communication: Excellent interpersonal, negotiation, verbal, and written communication skills.
    • Organizational: Strong organizational skills with the ability to manage multiple tasks and prioritize workload effectively.
    • Leadership: Proven leadership skills with the ability to make timely decisions and manage team performance.
    • Analytical Thinking: Strong analytical and problem-solving abilities with sound judgment.
    • Client Focused: Demonstrates a client-focused approach, building strong client relationships and promoting business opportunities.
    • Technical Proficiency: Advanced skills in Microsoft Word and Excel; familiarity with document management systems and collaborative authoring tools.

    Knowledge and Experience:

    • Regulatory/Pharmacovigilance Experience: Relevant experience in regulatory or pharmacovigilance medical writing is desirable.
    • Drug Safety Understanding: Comprehensive knowledge of drug safety, drug development processes, and regulatory guidelines.
    • Management Experience: Experience in managing aggregate and safety report writing projects, including people management in a billable service industry.
    • Project Management: Experience in project planning, monitoring, and resource management.
    • Business Development: Awareness of business development and strategic planning.

    Education:

    • Degree: A university degree in Life Sciences, Health Sciences, Biomedical Sciences, or a related field is required. A degree in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing is advantageous.
     

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