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    Director, Medical Writing Consultant - Fremont, CA, United States - Bayside Solutions

    Bayside Solutions
    Bayside Solutions Fremont, CA, United States

    2 weeks ago

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    Description

    Director, Medical Writing Consultant

    W2 Contract

    Salary Range: $208,000 - $249,600 per year

    Location: Redwood City, CA - Hybrid or Remote PST

    Job Summary:

    As Director, Medical Writing Consultant, you will be a strategic partner to senior leadership, accountable for efficiently preparing high-quality, strategically aligned medical writing deliverables that support our clinical program's clinical, safety, and regulatory requirements.

    You will drive the messaging strategy across a program of work, analyzing program-level and study-related documents for their ability to deliver the information required by regulatory authorities in a compelling fashion with accuracy and consistency.

    The Director will convey strategically aligned communication points in medical writing deliverables and that the communication points are consistent across program documentation, mitigating risks associated with medical writing and disclosure processes by establishing and maintaining Best Practices and SOPs.

    Duties and Responsibilities:

    • Efficiently prepare high-quality, strategically aligned medical writing deliverables and ensuring effective communication underpins successful clinical development.
    • Prepare high-quality medical writing deliverables for assigned clinical program(s) according to budget and timelines.
    • Build convincing clinical, safety, and regulatory arguments within and across documents using logic, analogy, and therapeutic area science.
    • Ensure that statements in deliverables are accurate and supported by appropriate data.
    • Align, coordinate, and build consistent information and messages across all individual documents within a clinical program, starting with initial strategic plans and continuing through study-level documents to final program-level deliverables, including regulatory submissions or publications of key journal articles for a publication plan.
    • Understand where all intended messages will be located across individual documents within a clinical program and ensure messaging alignment across documents.
    • Understand issues affecting clinical development strategy design and how study design, data capture, and statistical analysis plan design will affect downstream documents.
    • Liaise with functional groups internal and external to R&D to ensure independent and interdependent communication needs and strategies are considered during document development (e.g., communicating data in a CSR and regulatory documents to support NDA and Advisory Committee positioning).
    • Be accountable for medical writing deliverable quality and ensure work on assigned projects adheres to departmental procedures, practices, and industry/international standards.
    • Set program-level standards (e.g., style convention).
    • Drive the development, implementation, and communication of Best Practices, SOPs, templates, work instructions, style guides, and content guides to ensure efficient preparation of high-quality medical writing deliverables.

    Requirements and Qualifications:

    • BA/BS or higher and at least 6 years of writing experience at the senior level in the pharmaceutical industry
    • Exceptional English language skills and the ability to write and edit complex material to ensure accuracy, clarity, and effectiveness
    • A solid understanding of the clinical development process, including the required documents at each stage
    • A comprehensive understanding of medical writing processes, standards, and issues
    • Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics, and templates
    • Excellent written and oral communication skills and demonstrated problem-solving abilities.
    • Knowledge of eTechnology related to regulatory submission activities (e.g., eCTD).
    • Experience in hematology/oncology/ophthalmology/allergy therapeutic area
    • Able to think strategically
    • Strong, positive interpersonal skills
    • Demonstrated negotiating skills and resourcefulness
    • Demonstrated ability to manage several projects simultaneously
    • Able to critically analyze, interpret, and synthesize complex scientific information
    • Strong influencing skills and ability to lead without formal authority
    • The high degree of influencing skills in shaping and developing content and wording
    • Can manage uncertainty and shifting priorities and timelines
    • Demonstrated ability to work collaboratively; multicultural sensitivity; builds positive and productive relationships; seeks input and reflects an appreciation for diverse views by incorporating them into decisions/proposals
    • Successful track record of leading complex clinical/regulatory writing projects
    • Demonstrated ability to make decisions even in the absence of complete information
    • An excellent understanding of all aspects of ICH-GCP; keen insight into external clinical publication practices and standards (ICMJE, AMA, GPP)
    • Excellent organizational and time management skills
    • Attention to detail

    Desired Skills and Experience

    Medical Writing, clinical development, Microsoft Office, eCTD, ICH-GCP, SOPs

    Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at

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