Senior Director, Medical & Regulatory Writing

🕒 April 16

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $265k - $306k / year

⏰ Full Time

🟠 Senior

✏️ Content Writer

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Kura Oncology, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2014

🧬 Biotechnology

💊 Pharmaceuticals

💰 $125M Post-IPO Debt on 2022-11

Biotechnology • Pharmaceuticals

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

• The Senior Director, Medical & Regulatory Writing serves as subject matter expert on clinical protocols, protocol amendments, clinical study reports, Investigator’s Brochures, and briefing books. • May also provide guidance on document strategy for more complex dossiers for regulatory submission such as IND and NDA/BLA filings. • The position requires the ability to work collaboratively with cross-functional teams in a fast-paced environment. • The qualified candidate will also have experience in management of external vendors and the development of operational process improvements such as work practice documents, SOP development and updates, and document templates. • There will need to be a very strong understanding of document timelines as planning is critical.

🎯 Requirements

• Bachelor’s, Master’s or PhD Degree in scientific, medical, clinical discipline or related field is required. Masters or Ph.D. degree is preferred. • Strong track record of people management and delegating work. • 12+ years of relevant industry experience as a medical writer in a pharmaceutical, biotech, or CRO environment. Oncology experience preferred. • Must have experience authoring clinical study reports, protocols, protocol amendments, Investigator’s Brochure. Experience authoring and managing briefing books is a plus. • Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus • Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus. • Project management skills as related to medical writing. • Ability to manage complex writing projects with minimal supervision. • Must have the ability to edit text for brevity and clarity. • Ability to understand, interpret and present complex clinical data. • Must be highly detail oriented. • Ability to coordinate multiple documents while effectively managing timelines. • High degree of independence in decision making and problem solving. • Leads decision-making across multiple programs or areas, setting direction and making strategic trade-offs that impact cross-functional execution and outcomes. • Drives cross-functional alignment across multiple programs, influencing stakeholders to shape strategy and ensure cohesive execution across functions. • Understanding of FDA and ICH regulations and guidelines. • Familiarity with eCTD-compliant templates and with the use of document formatting tools such as ISI writer, Liquent Smart Desk, Acumen Stylus, or other formatting tools. • Must be an expert with MS Word and have a solid working knowledge of MS Excel, MS PowerPoint, and MS Project. • Experience in use of an EDMS such as Documentum, Core Dossier, or Veeva.

🏖️ Benefits

• Career advancement/ development opportunities • Competitive comp package • Bonus • 401K + Employer contributions • Generous stock options • ESPP Plan • 20 days of PTO to start • 18 Holidays (Including Summer & Winter Break) • Generous Benefits Package with a variety of plans available with a substantial employer match • 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 much more!