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    Senior Manager, Medical Writing Services

    Parexel
    3+ years
    Not Disclosed
    Mohali
    10 March 2, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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 Title: Senior Manager, Medical Writing Services

    Location: Sahibzada Ajit Singh Nagar, Punjab, India
    Employment Type: Full-Time (On-Site)

    Key Accountabilities:

    Line Management and General Management:

    • Supervise and mentor line reports, including hiring, training, performance evaluations, compensation recommendations, and promotions.
    • Ensure compliance with departmental procedures and health authority regulations.
    • Validate quality and training compliance.
    • Ensure appropriate billable time for line reports.
    • Provide situational leadership, delegation, and accountability.
    • Manage employee performance, retention, and talent development.
    • Attend and chair manager meetings as needed.
    • Approve expenses, invoices, and purchase orders as authorized.

    Client Liaison/Service:

    • Maintain collaborative client relationships to promote satisfaction and confidence.
    • Implement key performance indicators (KPIs) for continuous improvement.
    • Respond to client feedback and dissatisfaction appropriately.
    • Assist in proposal generation and strategic project planning.
    • Provide assessments of service scope and estimated effort.
    • Support business development efforts and identify new business leads.

    Industry Experience Application:

    • Understand client challenges and propose strategic solutions.
    • Utilize industry awareness to identify new opportunities for clients.

    Project Management:

    • Manage stakeholder relationships, partnerships, and operations.
    • Set clear objectives and monitor team performance.
    • Oversee project progress, ensuring timelines and deliverables are met.
    • Provide leadership, strategic planning, and resource management.
    • Identify and implement creative solutions for staffing and scheduling needs.

    Process Development and Improvement:

    • Ensure efficient budgeting and financial monitoring.
    • Stay updated on and contribute to SOPs and guidelines.
    • Analyze workflow efficiency and propose improvements.
    • Provide regulatory guidance on safety report writing.
    • Participate in internal and external audits.

    Authoring and Consultancy:

    • Develop and finalize safety reports, CSR narratives, and other regulatory documents.
    • Provide expert guidance on regulatory requirements (ICH, GVP, FDA, EMA, etc.).

    Signal Detection and Management:

    • Conduct qualitative and quantitative signal detection analysis.
    • Manage signal tracking, assessment, and review meetings.
    • Ensure adherence to SOPs and regulatory guidelines.

    Quality Control:

    • Ensure timely and high-quality project completion.
    • Provide technical leadership for regulatory compliance.

    Training and Compliance:

    • Stay updated on regulatory advancements and industry trends.
    • Develop training materials and mentor staff.
    • Present technical knowledge to improve writing efficiency.

    General Responsibilities:

    • Participate in process improvement and departmental committees.
    • Foster a positive, results-oriented work environment.
    • Provide leadership coverage when required.
    • Represent and promote the medical writing profession.

    Skills and Competencies:

    • Strong interpersonal, negotiation, and communication skills.
    • Ability to work independently in a fast-paced environment.
    • Exceptional organizational and multitasking abilities.
    • Experience in leadership, decision-making, and client management.
    • Logical thinking and problem-solving skills.
    • Client-focused approach with business acumen.
    • Proficiency in Microsoft Office and document management systems.

    Knowledge and Experience:

    • Experience in Regulatory/Pharmacovigilance or related fields.
    • In-depth knowledge of drug safety, development processes, and regulatory guidelines.
    • Proven track record in safety report writing and project management.
    • Business development experience preferred.
    • Ability to travel as required.
    • Fluent in written and spoken English.

    Education:

    • Required: University degree in Life Sciences/Health/Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.).
    • Preferred: Degree in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing with hospital-based patient exposure.

     

     

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