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Assistant Team Lead - Concierge

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South San Francisco, CA 94080
12.1 miles
Full-time, Part-time

    Director Medical Writing

    Iovance Biotherapeutics
    San Carlos, CA 94070
    Full-time, Part-time
    Refer friends, get paid!

    Job Description

    Overview

    The Director, Medical Writing reports to the CMO and will support Clinical Science, Regulatory, and Safety functions.

    Specific Responsibilities:

    • Manage, write, and edit clinical, regulatory, and safety documents for Iovance programs.
    • Write clinical study protocols and amendments, Investigator's Brochures, DSURs, and other medical/regulatory documents.
    • Develop and manage timelines and resources. Collaborate cross-functionally to drive projects to completion.
    • Write, and oversee the writing and review of documents toward regulatory submissions such as INDs and BLAs.
    • Write publications such as abstracts, posters, PowerPoint presentations, manuscripts.
    • Develop standards and processes for clinical document production.
    • May manage additional medical writers (employees and contractors).
    • May oversee clinical library/information systems (Endnote).
    • Other duties as assigned.

    Education and Qualifications:

    • PhD/master's degree in a life sciences discipline (advanced degree preferred) or equivalent experience and a minimum of 12 years' biopharmaceutical industry experience.
    • Experience drafting clinical protocols and Investigator's Brochures. Prior regulatory submission experience preferred, especially work toward IND and BLA submissions.
    • In-depth understanding of regulatory/ICH guidelines and GCPs, Good Publication Practices (GPP) and related standards (eg, CONSORT, ICMJE), and clinical trial transparency requirements (eg, EudraCT, CT.gov).
    • Expert abilities in Microsoft Office Suite, Adobe Acrobat, Visio, and electronic content management systems (SharePoint).
    • Experience with cross-functional collaboration and with managing priorities, timelines and writing resources.
    • Strong written and verbal communication skills.
    • Experience in oncology drug development. 
    • Experience working independently and leading teams to successful submissions.

    Physical Requirements:

    • Sit for extended period in front of computer

    Posting ID: 567400109Posted: 2020-08-09