Director, Medical & Regulatory Writing

🕒 September 30

🇺🇸 United States – Remote

💵 $182k - $256k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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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 subject matter expert in preparing clinical regulatory documents through all phases of clinical research • Provide guidance on document strategy for complex regulatory dossiers, including IND and NDA/BLA filings • Represent medical writing in cross-functional team meetings • Collaborate with clinical research, clinical operations, data management, biostatistics, regulatory affairs, and medical affairs teams to deliver high-quality documents on time • Adhere to ICH-E3 guidelines, federal regulations, and company SOPs • Develop, improve, and maintain medical writing work practice documents, SOPs, and document templates • Oversee external vendors, including contract writers, QC reviewers, and document formatters • Maintain current knowledge of industry trends and best practices for medical writing • Plan and manage document timelines • Perform other duties as assigned

🎯 Requirements

• Bachelor’s, Masters or PhD degree in scientific, medical, clinical discipline or related field is required; Masters or PhD degree is preferred • Minimum of 10–12 years of relevant industry experience as a medical writer in a pharmaceutical, biotech, or CRO environment • Oncology experience preferred • Experience authoring clinical study reports, protocols, protocol amendments, and Investigator’s Brochures • Experience authoring and managing briefing books is a plus • Experience in regulatory submissions presented to regulatory authorities is a plus • Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines is a plus • Project management skills as related to medical writing • Ability to manage complex writing projects with minimal supervision • Ability to edit text for brevity and clarity • Ability to understand, interpret, and present complex clinical data • Highly detail oriented • Ability to coordinate multiple documents while effectively managing timelines • High degree of independence in decision making and problem solving • Understanding of FDA and ICH regulations and guidelines • Familiarity with eCTD-compliant templates and document formatting tools such as ISI Writer, Liquent Smart Desk, Acumen Stylus, or other formatting tools • Expert with MS Word and solid working knowledge of MS Excel, MS PowerPoint, and MS Project • Experience using an EDMS such as Documentum, Core Dossier, or Veeva • Must have proficiency in EndNote or RightFind Cite It • Ability to own decision-making for the functional area or program, resolve complex issues, and make trade-offs with minimal escalation • Ability to lead cross-functional collaboration and proactively drive stakeholder alignment

🏖️ Benefits

• Generous benefits package with a variety of plans available with a substantial employer match • Career advancement/development opportunities • Competitive compensation package • 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 • 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

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