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    Associate Manager, Medical Writing Services

    Parexel
    2-5 years
    Preffered by Company
    Remote
    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: Associate Manager, Safety Services (SS)

    Role Overview:

    The Associate Manager, Safety Services, is pivotal in overseeing and supporting the writing and management of aggregate safety reports, clinical study report (CSR) narratives, and signal detection activities. This role involves managing project resources, leading a team, and acting as a Process Manager for specific aspects of the overall process. Additionally, you will support SS management in client interactions, proposal development, and contract reviews.

    Key Responsibilities:

    1. Line Management and General Oversight:

      • Supervise and mentor safety services staff, handling hiring, training, performance evaluations, and career development.
      • Ensure compliance with departmental procedures, health authority regulations, and quality standards.
      • Manage time tracking and quality for team members.
      • Address performance issues through coaching, training, and performance improvement plans or terminations as necessary.
      • Attend and chair management meetings as required.
      • Approve expenses, invoices, and purchase orders as authorized by SS management.

    2. Client Liaison and Service:

      • Understand and meet client expectations for both yourself and your team.
      • Build and maintain productive client relationships, addressing dissatisfaction and providing feedback to SS management.
      • Contribute to proposal development by assessing service scope, estimating task hours, and liaising with proposal teams or clients.
      • Represent the company in business development and proposal meetings.

    3. Project Management:

      • Set clear objectives for your team and monitor performance against these goals.
      • Communicate project scope, client expectations, and timelines effectively.
      • Track project progress, adjust strategies as needed, and provide updates to SS management.
      • Ensure project integrity and capture key learnings from each project.
      • Propose solutions for adjusting timelines and staffing to SS management.

    4. Subject Matter Expertise and Process Improvement:

      • Author and review aggregate safety reports and CSR narratives, ensuring regulatory compliance.
      • Contribute to process development and improvement, including budgeting and financial monitoring.
      • Analyze work efficiency and suggest improvements for processes and training.
      • Provide guidance on safety report writing guidelines and procedures.
      • Attend and respond to audits, addressing any issues highlighted.

    5. Signal Detection and Management:

      • Perform qualitative and quantitative signal detection reviews from various sources.
      • Manage the complete signal management process, including tracking, assessment, and leading review meetings.

    6. Quality Control:

      • Ensure timely and high-quality delivery of reports.
      • Provide technical leadership to ensure compliance with regulatory guidelines and SOPs.

    7. Training and Compliance:

      • Stay updated on regulatory changes and industry trends.
      • Develop and deliver training to enhance writing quality, efficiency, and project management.
      • Share knowledge from technical courses and provide training and mentoring to staff.

    8. General Responsibilities:

      • Foster a positive, results-oriented work environment with effective teamwork and communication.
      • Provide short-term coverage in the absence of other SS management and perform additional senior-level tasks as needed.

    Skills and Qualifications:

    • Skills:

      • Exceptional interpersonal, negotiation, verbal, and written communication skills.
      • Professional and adaptable with a strong motivation to work independently in a dynamic environment.
      • Proficient in managing multiple tasks, prioritizing workloads, and maintaining attention to detail.
      • Effective in a matrix environment, demonstrating strong team leadership and decision-making abilities.
      • Logical thinking, sound judgment, and problem-solving skills.
      • Positive attitude, flexibility, and ability to handle confidential information professionally.
      • Client-focused approach to build trust and expand business opportunities.

    • Knowledge and Experience:

      • Experience in managing pharmacovigilance, aggregate safety reports, or related projects.
      • Deep understanding of drug safety, drug development processes, and relevant regulatory guidelines.
      • Proven project management experience, including planning and monitoring.
      • Business development and awareness experience.
      • Advanced skills in Microsoft Office (Word, Excel) and familiarity with document management systems, collaborative authoring, and databases.
      • Ability to travel as needed.
      • Fluency in written and spoken English.

    • Education:

      • A university degree in Life Sciences, Health, or Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics).
      • Additional degrees in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing, involving patient exposure, are advantageous.

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