Jobs · Legal · California

Associate Director, Regulatory & Medical Writing

BioSpace · Brisbane, CA · 3 wk ago
Legal$216k–$235k/yrFull-time
We need to output HTML fragment with sections: Use

for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. The posting includes: Position Description (maybe "About the role" or "Opportunity"?). There's "Position Description" then bullet list of duties. There's "What You’ll Bring" which includes requirements, qualifications, skills. There's Salary Range (Pay). There's Location (maybe not a heading). There's "About Nurix Therapeutics" (company description) maybe not needed. There's "Fit with Nurix Culture and Values" maybe could be part of About the role? But we need to follow headings list. We must not repeat job title as heading. No Job ID. Remove boilerplate. We need to preserve all substantive info. We need to decide sections: - About the role: could include the introductory paragraph: "Help shape how Nurix communicates its science to health authorities and the world. As Associate Director, Regulatory & Medical Writing, you’ll independently lead the authoring, review, and approval of critical regulatory documents across our pipeline — from clinical protocols to health authority submissions. It’s a chance to bring clarity and strategic messaging to the documents that move our therapies through development and toward patients." - Responsibilities: the bullet list under "Position Description" (the list of duties). Those are responsibilities. - Requirements: maybe combine "What You’ll Bring" items that are requirements: 6 to 8+ years experience, experience identifying and interpreting info, involvement with ex-US submissions is a plus, ability to work effectively and lead in cross-functional groups, excellent communication skills, organizational skills, attention to detail, adaptable, knowledge of health authority requirements, ICH guidelines, eCTD, proficiency in project planning tools, Veeva RIM Suite, expertise in MS Word, document management systems. - Qualifications: maybe overlapping with requirements; but we could treat "What You’ll Bring" as Requirements and Qualifications combined? The instruction says we can have sections for Requirements, Qualifications, Skills. We need to decide what goes where. Could separate: Requirements = years of experience, experience with documents, ex-US submissions plus. Qualifications = education? Not given. Could skip Qualifications if no specific content. Skills = communication, organizational, attention to detail, adaptable, knowledge of guidelines, proficiency in tools, expertise in Word, etc. But we need to avoid thin sections. Perhaps combine Requirements and Qualifications into one? But we need to follow instruction: Use headings only when posting has real specific content. We can include Requirements, Qualifications, Skills if we have content. We have no explicit education qualification; maybe we can omit Qualifications. We have Salary Range: Pay section. Schedule: not mentioned; we should not include Schedule. Benefits: not mentioned; we should not include Benefits. Thus sections: About the role, Responsibilities, Requirements, Skills, Pay. We need to output HTML fragment with

headings and appropriate
  • for lists,

    for prose. We must preserve all substantive info: include location? Not under any heading; maybe we can include location in About the role paragraph? Could add a short

    for location and maybe culture fit? The instruction: "Do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

    or drop it." So we can include location and maybe culture fit in a

    under About the role or separate? Probably better to include location as a short

    after About the role heading? But we need to keep sections only when there is real specific content. Location is minor metadata; we could fold into a short

    under About the role or after it. The instruction says fold minor metadata into a short

    or drop it. So we can add a

    after the About the role heading containing location and maybe culture fit. But we also have "Fit with Nurix Culture and Values" which is substantive? It's a list of bullet points? Actually it's a short paragraph: "Strong team orientation; highly collaborative Solutions and results-oriented focus Hands-on approach; resourceful and open to diverse points of view". That's substantive but could be part of About the role or maybe a separate section? Not in headings list; we could incorporate into About the role as a

    . We also have "About Nurix Therapeutics" describing company; could be part of About the role as well. Thus About the role section will contain multiple paragraphs: the opportunity description, company description, culture fit, location. We need to ensure we don't invent or summarize away detail. We'll copy text verbatim where possible. Let's extract exact text: First paragraph: "Help shape how Nurix communicates its science to health authorities and the world. As Associate Director, Regulatory & Medical Writing, you’ll independently lead the authoring, review, and approval of critical regulatory documents across our pipeline — from clinical protocols to health authority submissions. It’s a chance to bring clarity and strategic messaging to the documents that move our therapies through development and toward patients." Then "Position Description" heading (we ignore heading). Then bullet list: - Author and manage authoring of Regulatory & Medical Writing documents together with cross-functional collaborators; ensure content consistency within a document and across documents for a particular asset, including the development of strategic messaging and data presentation in accordance with Nurix standards and health authority requirements, for documents such as: - Review, edit, and QC documents developed by other authors or medical writers - Manage the author, review, and approval process for multiple deliverables at a given time; ensure quality and timely completion, with attention to consistency of content, messaging, format, and style - Lead Regulatory & Medical Writing activities for assigned programs, including partnering with the Head of Regulatory & Medical Writing on resource planning, document timelines, issue resolution, and process improvement initiatives - Represent Regulatory & Medical Writing on interdisciplinary teams for assigned programs/projects, providing strategic input and status updates - Manage external Regulatory & Medical Writing resources for assigned programs/projects, as needed Note the first bullet seems incomplete: "for documents such as:" then maybe missing list; but we keep as is. Then "What You’ll Bring" heading. Then bullet list: - 6 to 8+ years of Regulatory and/or Medical Writing, or other relevant pharmaceutical/biotechnology industry experience in the Clinical Development phase, authoring and overseeing documents submitted to health authorities - Experience identifying and interpreting information/data for inclusion in documents such as clinical study protocols, Investigator’s Brochures, clinical study reports, Lay Summaries, and ICFs - Involvement with ex-US submissions for clinical trial applications and marketing applications is a plus - Ability to work effectively and lead in cross-functional working groups - Excellent communication skills, organizational skills, and attention to detail - Adaptable and flexible, willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism - Knowledge of health authority requirements, ICH guidelines, and submission-ready standards relevant to document authoring, including eCTD and submission lifecycle management - Proficiency in project planning tools such as MS Project or Smartsheet, collaborative authoring or document review tools, and Veeva RIM Suite - Expertise in Microsoft Word (including use of customized toolbars/templates) and document management systems Then "Salary Range: $216,400 - $234,800 The posted range applies to roles based in the San Francisco Bay Area and reflects local market conditions. Where an offer lands within that range depends on the candidate’s relevant experience, technical expertise, and how their background aligns with the role’s requirements." Then "Location: Onsite – Brisbane, CA" Then "Fit with Nurix Culture and Values Strong team orientation; highly collaborative Solutions and results-oriented focus Hands-on approach; resourceful and open to diverse points of view" Then "About Nurix Therapeutics Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease." We need to output HTML fragment. We'll structure:

    About the role

    Help shape how Nurix communicates its science to health authorities and the world. As Associate Director, Regulatory & Medical Writing, you’ll independently lead the authoring, review, and approval of critical regulatory documents across our pipeline — from clinical protocols to health authority submissions. It’s a chance to bring clarity and strategic messaging to the documents that move our therapies through development and toward patients.

    Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

    Fit with Nurix Culture and Values: Strong team orientation; highly collaborative. Solutions and results-oriented focus. Hands-on approach; resourceful and open to diverse points of view.

    Location: Onsite – Brisbane, CA

    Then Responsibilities:

    Responsibilities

    • Author and manage authoring of Regulatory & Medical Writing documents together with cross-functional collaborators; ensure content consistency within a document and across documents for a particular asset, including the development of strategic messaging and data presentation in accordance with Nurix standards and health authority requirements, for documents such as:
    • Review, edit, and QC documents developed by other authors or medical writers
    • Manage the author, review, and approval process for multiple deliverables at a given time; ensure quality and timely completion, with attention to consistency of content, messaging, format, and style
    • Lead Regulatory & Medical Writing activities for assigned programs, including partnering with the Head of Regulatory & Medical Writing on resource planning, document timelines, issue resolution, and process improvement initiatives
    • Represent Regulatory & Medical Writing on interdisciplinary teams for assigned programs/projects, providing strategic input and status updates
    • Manage external Regulatory & Medical Writing resources for assigned programs/projects, as needed
    Then Requirements:

    Requirements

    • 6 to 8+ years of Regulatory and/or Medical Writing, or other relevant pharmaceutical/biotechnology industry experience in the Clinical Development phase, authoring and overseeing documents submitted to health authorities
    • Experience identifying and interpreting information/data for inclusion in documents such as clinical study protocols, Investigator’s Brochures, clinical study reports, Lay Summaries, and ICFs
    • Involvement with ex-US submissions for clinical trial applications and marketing applications is a plus
    • Ability to work effectively and lead in cross-functional working groups
    • Excellent communication skills, organizational skills, and attention to detail
    • Adaptable and flexible, willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism
    • Knowledge of health authority requirements, ICH guidelines, and submission-ready standards relevant to document authoring, including eCTD and submission lifecycle management
    • Proficiency in project planning tools such as MS Project or Smartsheet, collaborative authoring or document review tools, and V

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