Director, Global Medical Writing

🔥 1 minute ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $175k - $215k / year

⏰ Full Time

🔴 Lead

✏️ Content Writer

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This company has sponsored H1B visas in the past.

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Deciphera Pharmaceuticals

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2016

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Deciphera Pharmaceuticals is a biotechnology company dedicated to defeating cancer by developing innovative kinase inhibitors to improve patient outcomes. The company focuses on designing switch-control kinase inhibitors to address mechanisms of tumor and drug resistance, aiming to enhance treatment responses for patients with cancer. Deciphera has a diverse pipeline of drug candidates, including ripretinib and vimseltinib, and is committed to making a significant impact on the lives of cancer patients. As of June 2024, Deciphera is a wholly-owned subsidiary of ONO Pharma and continues to work on improving human health through its scientific innovations and patient-centric approach.

📋 Description

• Serve as lead writer across clinical programs and submissions in the clinical pipeline • Independently write and manage clinical study-related documents, including clinical study protocols, master protocols, Investigator’s brochures, and clinical study reports • Lead cross-functional teams developing regulatory submission documents, regulatory response documents, and IND/CTA or global regulatory submission documents • Lead Medical Writing for one or more clinical programs, including planning, developing, and implementing content strategy • Represent Medical Writing on cross-functional clinical, regulatory, and submission teams • Participate in NDA/MAA/IND submission planning and documentation • Author and manage clinical documents and assigned tasks within established timelines and quality standards • Drive document strategies and messaging with project-team subject matter experts • Maintain current knowledge of medical writing developments and related technologies • Incorporate process improvements aligned with R&D needs • Plan and coordinate work with in-house Medical Writers and outside CROs • Perform medical literature searches • Participate in company-wide initiatives, including protocol template working groups and IB standardization • Review medical writing deliverables, statistical analysis plans, tables, figures, and listings as needed • Manage and mentor 1–2 direct reports, with future oversight of writing across a therapeutic area • Report to the Senior Director, Global Medical Writing

🎯 Requirements

• Advanced degree (MS or Ph.D.) in a relevant scientific field; Ph.D. preferred • Minimum of 8–10 years of medical writing experience • Expert knowledge and experience preparing high-quality clinical and regulatory documents • Knowledge of clinical trial disclosure • Experience authoring regulatory and clinical documents for global submissions, including NDA, NDS, MAA, and IND submissions across ICH regions • Active contribution to planning and preparation of summary documents • Excellent verbal and written communication skills • Attention to detail regarding consistency, grammar, syntax, and accuracy • Strong organizational and prioritization skills for managing multiple concurrent documents • Proficiency with eCTD Starting Point templates, Smart Sheet, databases, presentation software, MS Office (Teams, Outlook, Word, Excel, PowerPoint, SharePoint), Veeva Vault, and Please Review • Oncology, immunology, and/or neurology experience highly preferred

🏖️ Benefits

• Annual performance bonus • Long-term incentive plan • Medical insurance • Dental insurance • Vision insurance • 401(k) retirement plan with company match • Generous parental leave • Family planning benefits • Opportunities for personal and professional growth