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    Medical Writing Manager

    Thermo Fisher Scientific
    7+ years
    Not Disclosed
    Remote
    10 Oct. 30, 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

    Job Title: Manager, Clinical Document Review
    Work Schedule: Standard (Mon-Fri)
    Environmental Conditions: Office

    Job Description:

    Summarized Purpose:
    The Manager of Clinical Document Review effectively oversees staff and related projects to deliver high-quality products within agreed timelines. This role supports operational excellence, initiates departmental improvements, mentors staff, and collaborates with both internal teams and external clients. The manager also works to resolve complex problems to meet client deliverables and needs.

    Essential Functions:

    • Staff Management:

      • Manage staff activities including interviewing, selection, job description preparation, professional development, goal setting, performance management, coaching, mentoring, counseling, and separations.
      • Approve actions regarding salary administration, hiring, corrective actions, and terminations. Review and approve time records, expense reports, leave requests, and overtime.

    • Team Operations:

      • Direct daily operations and address inquiries from the team and other departments, ensuring timely organization of multiple complex deliverables.
      • Lead and contribute to team meetings.

    • Project Oversight:

      • Serve as lead reviewer on large-scale projects, collaborating with internal and external clients to meet deliverable timelines.
      • Maintain knowledge of and communicate updated guidelines and regulations regarding clinical trials and submission specifications.

    • Operational Excellence:

      • Monitor performance metrics to ensure efficient processes and initiate improvements by influencing workflows and technology.
      • Participate in meetings and contribute to departmental activities.

    • Process Development:

      • Assist in developing, documenting, and maintaining business processes for document review through SOPs, WPDs, and guidelines.
      • Interpret and administer policies that may affect sections and subordinate work units, requiring comprehensive knowledge of functional responsibilities.

    • Liaison Responsibilities:

      • Interact frequently with internal personnel and external representatives, participating in and presenting at meetings to resolve operational and scheduling issues.

    Qualifications:

    • Education and Experience:

      • Bachelor’s degree or equivalent formal academic/vocational qualification.
      • 7+ years of relevant experience, including at least 1 year in a leadership role.
      • Equivalent combinations of education, training, and experience will also be considered.

    • Knowledge, Skills, and Abilities:

      • Ability to delegate tasks and facilitate completion of assignments.
      • Effective management skills, including budget creation, project timelines, resource allocation, and workload forecasting.
      • Proven innovation in process improvement.
      • Strong knowledge of document and quality review.
      • Proficiency in Microsoft Word and Excel.
      • Advanced organizational, analytical, and interpersonal skills for managing complex projects and shifting priorities.
      • Capability to assess client needs independently and collaborate on compliant deliverables.
      • Advanced editorial and proofreading skills.
      • Strong leadership skills with a diverse staff.
      • Ability to analyze complex problems and evaluate intangible variables.
      • Capacity to exercise independent judgment in developing methods and criteria for achieving results.
      • Ability to remain motivated and manage pressure while working independently and collaboratively in a cross-cultural, geographically dispersed environment.

    Management Role:
    Manages experienced professionals or subordinate management, often overseeing one or more sections or a small department.

    Working Conditions and Environment:
    Work is performed in an office and/or clinical environment, with exposure to electrical office equipment.

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