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    Associate Manager, Safety Medical Writing

    Parexel
    5+ years
    Not Disclosed
    Bangalore
    10 Sept. 7, 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

    Associate Manager, Safety Services

    Job Purpose:

    The Associate Manager, Safety Services (SS) is pivotal in overseeing and supporting aggregate safety report writing staff, clinical study report (CSR) narratives staff, and signal detection and management activities. This role includes managing projects and resources, acting as a Process Manager for specific segments of the overall process, and potentially handling line management responsibilities. Additionally, the Associate Manager may support SS management in client interactions, proposals, and contract reviews.

    Key Accountabilities:

    Line Management and General Management:

    • Supervise and mentor team members, managing all aspects of personnel management including hiring, training, professional development, performance evaluations, and adherence to departmental procedures.
    • Ensure the quality of work and compliance with training requirements.
    • Oversee billable time management and performance metrics.
    • Address performance issues through coaching and development or execute performance improvement plans if needed.
    • Attend and chair manager meetings as required.
    • Authorize expenses, invoices, and purchase orders as permitted.

    Client Liaison/Service:

    • Understand and meet client expectations, fostering collaborative relationships to enhance satisfaction and confidence.
    • Implement performance measures and feedback mechanisms to optimize team performance.
    • Provide strategic input during proposal generation, assessing scope, estimating hours, and ensuring comprehensive coverage of services.
    • Represent the company in business development and proposal meetings as needed.

    Project Management:

    • Manage relationships with partners, stakeholders, and clients, ensuring clear objectives and effective communication.
    • Monitor project timelines and progress, making adjustments as needed to meet goals.
    • Provide leadership in strategic planning and project management, ensuring project integrity and capturing key learning experiences.
    • Update SS management on project status and propose solutions for timeline or staffing changes.

    Subject Matter Expertise:

    • Author and review aggregate safety reports and CSR narratives.
    • Advise on regulatory issues and submissions in line with ICH, GVP, FDA, EMA, and other guidelines.
    • Conduct signal detection and management, including qualitative and quantitative analysis, tracking, and leading review meetings.

    Quality Control:

    • Ensure timely, high-quality delivery of reports.
    • Verify adherence to regulatory guidelines and SOPs for project completion.
    • Provide technical leadership to ensure data accuracy and compliance.

    Training/Compliance:

    • Stay updated on regulatory advances and industry trends.
    • Develop and deliver training materials to enhance team skills and project management.
    • Mentor and train SS staff, sharing knowledge from technical courses and new developments.

    General:

    • Maintain a positive, results-oriented work environment and model teamwork and effective communication.
    • Provide short-term coverage for other SS management roles as needed.
    • Perform additional senior-level tasks with appropriate support and supervision.
    • Promote the medical writing profession internally and externally.

    Skills:

    • Excellent interpersonal, negotiation, and communication skills.
    • Ability to work independently and manage multiple tasks in a dynamic environment.
    • Strong organizational skills and attention to detail.
    • Effective in a matrix environment with a collaborative approach.
    • Proficient in logical thinking and decision-making with a client-focused mindset.
    • Professional handling of confidential information.

    Knowledge and Experience:

    • Relevant experience in regulatory or pharmacovigilance medical writing.
    • Understanding of drug safety, the drug development process, and regulatory guidelines.
    • Experience in managing aggregate safety reports and projects.
    • Prior line management experience is preferred, with a background in a billable service industry.
    • Proficiency in project management, resource management, and productivity metrics.
    • Business development experience and advanced skills in Microsoft Office (Word, Excel), document management systems, and collaborative tools.
    • Ability to travel as required.
    • Fluent in written and spoken English.

    Education:

    • A degree in Life Sciences, Health, Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology), or a related field.
    • A degree in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing with patient exposure is advantageous.

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