Associate Director, Medical & Regulatory Writing

Job not on LinkedIn

🔥 13 hours ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $184k - $211k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 0%

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Kura Oncology, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2014

🏥 Healthcare

🍽️ Food & Beverage

💼 Consulting

💰 $125M Post-IPO Debt on 2022-11

Healthcare • Food & Beverage • Consulting

Kura Oncology, Inc. is a biopharmaceutical company specializing in the discovery and development of precision medicines designed to target cancer cells selectively. The company focuses on creating novel therapies aimed at improving patient outcomes in areas with significant unmet medical needs, such as head and neck cancer, lung cancer, and acute leukemias. Kura Oncology conducts clinical trials for its pipeline products, including Ziftomenib and Tipifarnib, to find effective treatments for conditions like Acute Myeloid Leukemia and Head and Neck Squamous Cell Carcinoma. The company is committed to the promise of precision oncology, striving to improve the quality and longevity of life for cancer patients by combining innovative therapies with existing standards of care.

📋 Description

• Serve as medical writer and subject matter expert preparing clinical regulatory documents through all phases of clinical research • Execute the clinical trial transparency and disclosure book of work and provide vendor oversight • Collaborate with regulatory affairs, clinical development, clinical operations, biostatistics, pharmacology, translational research, manufacturing, and other cross-functional teams • Manage document review processes and resolve conflicting or ambiguous comments • Establish and monitor timelines for document deliverables • Prepare documents according to agreed timelines and regulatory standards, including ICH-E3 and company SOPs • Develop, improve, and maintain medical writing work-practice documents, SOPs, and templates • Represent medical writing in cross-functional meetings • Lead global clinical trial transparency and disclosure policy development • Lead preparation and maintenance of CCI and PPD rules across programs • Apply lean writing practices to minimize CCI and PPD • Analyze, validate, and prioritize complex information from diverse sources • Manage, track, and present assigned work; compile and report performance metrics • Manage plain-language synopses, summaries, and clinical-document redactions under FDA, EMA, EU Clinical Trial Regulation, Health Canada PRCI, and other global requirements • Educate the company on transparency/disclosure regulations, industry trends, layperson summaries, and clinical study diversity planning • Coordinate cross-functional teams and liaise between vendors and internal teams for documents and postings • Collaborate on diversity action plans in accordance with FDA guidance • Coordinate multiple projects and programs aligned with corporate timelines and strategic plans • Maintain current knowledge of medical-writing industry trends and best practices • Perform other duties as assigned

🎯 Requirements

• Masters or advanced degree in scientific, medical, or clinical discipline (e.g., PhD, PharmD, or equivalent) is required; PhD preferred • Minimum of 8–10 years of relevant industry experience as a regulatory/scientific writer in a pharmaceutical, biotech, or CRO environment • CTD experience; vendor oversight a plus • Experience authoring clinical study reports, protocols, protocol amendments, and Investigator’s Brochures • Experience authoring briefing books and Module 2 clinical summaries is a plus • Solid understanding of drug development, clinical research, data analysis, CTD, ICH guidelines, GxP, regulatory interactions, and relevant regulations and guidance • Ability to manage competing priorities in a fast-paced environment • Excellent problem-solving, organizational, analytical, and critical-thinking skills • Excellent written and verbal communication skills • Strong attention to detail regarding consistency, grammar, syntax, and formatting • Familiarity with eCTD-compliant templates and formatting tools such as ISI Writer, Liquent Smart Desk, or Acumen Stylus is a plus • Proficient in MS Office Suite, EndNote, and Adobe Acrobat • Experience with an EDMS such as Documentum, Core Dossier, or Veeva • Ability to travel up to approximately 10% of the time • Ability to work collaboratively and facilitate cross-functional coordination • Must have proficiency in Veeva or equivalent software for document creation, review, and QC

🏖️ Benefits

• Generous benefits package with a variety of plans available with a substantial employer match • Annual target bonus • 401K + employer contributions • Generous stock options • ESPP Plan • 20 days of PTO to start • 18 holidays, including Summer & Winter Break • Paid paternity/maternity leave • Career advancement/development opportunities • In-office catered lunches • Home office setup • Lifestyle spending stipend • Commuter stipend (Boston Office) • Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and more