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    Oncology Medical Writer (Senior Manager/Associate Director)

    Pfizer
    10+ years
    Not Disclosed
    Remote, USA
    10 Nov. 13, 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

    Job Title: Medical Writer (Senior Manager/Associate Director)
    Location: Remote – Field Based

    Role Summary
    The Medical Writer (Senior Manager/Associate Director) is responsible for creating clinical study documents and regulatory interaction materials, such as protocols, clinical study reports, briefing documents, clinical summaries for marketing applications, and regulatory query responses. This role requires proficiency in scientific writing, with a focus on clear and concise communication for diverse audiences. The position involves analyzing, interpreting, and synthesizing data to produce high-quality documents that meet regulatory requirements. The role requires a comprehensive understanding of regulatory guidance and the drug development process.

    Key Responsibilities

    • Independently author complex documents, ensuring compliance with internal processes, external regulatory guidance, and quality standards.
    • Lead document development processes, collaborating with cross-functional teams, subject matter experts, and quality lines to ensure clear and accurate content.
    • Drive decision-making on data presentation strategies and engage with project teams early to plan and review document elements like tables, listings, and figures.
    • Manage project timelines, delivering documents on or ahead of schedule, and alerting teams of any potential delays or quality issues.
    • Negotiate resource and timeline needs with project teams, ensuring alignment with department goals.
    • Contribute to continuous improvement initiatives for processes, templates, procedures, and onboarding materials.
    • Serve as the Medical Writing point of contact for documents related to specific assets, ensuring alignment with business goals and quality standards.
    • Collaborate with vendors to produce documents as needed.

    Basic Qualifications

    • Bachelor’s degree, preferably in life sciences.
    • 7+ years of experience in medical writing (BS/BA), 5+ years (MS/MA), or 2+ years (PhD).
    • Extensive knowledge of global regulatory guidance (e.g., ICH, FDA, EMA).
    • Strong analytical skills, with the ability to interpret data and draft clear, concise documents.
    • Excellent organizational and project management skills, with the ability to work under pressure and handle multiple tasks.
    • High fluency in spoken and written English, with strong interpersonal and influencing skills.
    • Proficient in Microsoft Word and other relevant software (PowerPoint, Excel).
    • Experience with document management systems and collaboration software is preferred.

    Preferred Qualifications

    • Advanced degree (MS/MA/PhD).
    • Experience with document management systems and co-authoring principles.
    • Prior experience in drug development, clinical data interpretation, and regulatory documentation.

    Physical and Mental Requirements

    • Ability to work in an office-based environment, attend meetings, and make presentations.
    • Professional communication skills for discussing clinical data succinctly and accurately across teams and levels of management.

    Non-Standard Work Schedule, Travel, or Environment Requirements

    • Some travel (~5%) for meetings at GPD sites.
    • Global teleconference calls requiring flexibility across time zones.

    Compensation

    • Annual base salary range: $99,900.00 - $166,500.00.
    • Eligible for Pfizer’s Global Performance Plan with a bonus target of 15% of base salary and share-based long-term incentive participation.
    • Comprehensive benefits include a 401(k) plan, paid leave, health coverage, and other programs.

    EEO & Employment Eligibility
    Pfizer is committed to equal opportunity and complies with all applicable laws regarding nondiscrimination and work authorization. Pfizer is an E-Verify employer.

    Work Location Assignment: Remote
    Job Posting Location: Pfizer

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