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    Icf Medical Writing Program Manager

    Thermo Fisher Scientific
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 11, 2024
    Job Description
    Job Type: Full Time Remote 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

    Company Overview:

    At Thermo Fisher Scientific, we enable our customers to make the world healthier, cleaner, and safer. With a global presence and clinical trials conducted in over 100 countries, we advance the science of life-changing therapies. Our teams drive innovative solutions across laboratory services, digital and decentralized clinical trials, delivering high-quality outcomes to improve health worldwide. Join us in making an impact by contributing to groundbreaking research.

    Position Overview:

    We are seeking an ICF Medical Writing Program Manager to lead and manage patient-centric medical writing programs with a special focus on Informed Consent Forms (ICFs). As a key member of our team, you will oversee complex medical writing projects, collaborate with clients and cross-functional teams, and ensure the flawless delivery of ICFs. This role provides an opportunity to shape impactful research and improve health outcomes through high-quality medical documentation.

    Key Responsibilities:

    • Project Management: Develop and manage project plans and timelines, ensuring successful delivery of medical writing programs and ICFs.
    • Client Engagement: Cultivate strong relationships with clients, understanding their needs and delivering high-quality ICFs within required timelines.
    • Cross-Functional Collaboration: Work with internal and external teams to ensure alignment, provide status updates, and resolve project-related issues.
    • Mentorship: Mentor and guide junior staff, promoting a culture of learning and ensuring compliance with quality standards and best practices.
    • Compliance & Quality Assurance: Ensure all ICF documents meet regulatory requirements, industry guidelines, and client specifications.
    • Resource Management: Oversee budgeting, forecasting, and resource allocation to support timely and efficient project execution.

    Keys to Success:

    • Advanced Project Management Skills: Ability to plan, prioritize, and manage multiple projects effectively.
    • Excellent Communication & Negotiation: Strong written and verbal communication skills, with the ability to influence and negotiate with stakeholders.
    • Regulatory Expertise: In-depth knowledge of regulatory requirements and medical writing document development guidelines.
    • Leadership & Mentoring: Proven ability to lead and mentor a team, guiding junior writers and ensuring high standards of work.
    • Organizational Excellence: Outstanding organizational and planning skills, with an eye for detail and adherence to deadlines.

    Education & Experience:

    • Education: BS/BA in a scientific field (or related discipline), with at least 8 years of relevant experience in medical writing or clinical project management, or a Master’s/Advanced degree with 6+ years of experience.
    • Experience:
      • Proven experience in managing medical writing or clinical projects, especially in regulatory or plain language writing.
      • Experience in the pharmaceutical or CRO industry is preferred.

    Skills & Abilities:

    • Advanced Project Management: Skills in budgeting, forecasting, and resource management.
    • Excellent Communication: Strong interpersonal, oral, and written communication abilities.
    • Leadership: Proven experience leading teams and providing mentorship to junior staff.
    • Detail-Oriented: Strong organizational and time-management skills with a focus on quality and accuracy.
    • Adaptability: Ability to manage multiple projects simultaneously and meet tight deadlines.

    Work Environment & Physical Requirements:

    • Work Environment: This role is office-based with the flexibility for remote work as needed.
    • Physical Requirements: Candidates must be able to work under strict deadlines and manage multiple projects simultaneously.

    What We Offer:

    Thermo Fisher Scientific provides competitive compensation, an annual incentive plan, healthcare benefits, and a variety of employee perks. As part of our diverse and inclusive team of over 100,000 colleagues, you will have the opportunity to grow professionally and make meaningful contributions in an innovative and forward-thinking organization.

    Our Mission is to enable our customers to make the world healthier, cleaner, and safer. We promote a culture based on Integrity, Intensity, Innovation, and Involvement. Join us today and be part of our mission to accelerate research and drive scientific progress!

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