Senior Medical Writer

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $101.7k - $136.7k / year

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 0%

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Write, edit, and format clinical regulatory documents according to domestic and/or international regulatory submission and internal standards • Produce study reports, clinical study protocols and amendments, investigator brochures, and clinical sections of INDs, NDAs, MAAs, and other regulatory submissions • Work with cross-functional groups to produce high-quality, scientifically accurate documents under strict timelines • Ensure consistency between related documents • Ensure assigned documents undergo quality checks before approval • Route documents correctly during review and approval cycles • Manage timelines and communicate expectations, milestones, and deliverables • Review and edit documents authored internally and externally • Develop and maintain medical writing processes, standards, and tools • Ensure clinical documents adhere to BeOne standards and regulatory guidelines • Coordinate and manage contract medical writers as needed

🎯 Requirements

• At a minimum 4 years' relevant industry experience as a regulatory medical writer • BA/BS degree • Demonstrated ability to communicate and write English clearly, concisely, and effectively • Recent and significant experience writing regulatory documents such as clinical study reports, protocols, and protocol amendments • Keen understanding of FDA and ICH regulatory submission requirements • Experience writing clinical sections of INDs, MAAs, and NDAs is a plus • Working knowledge of drug/biologics development, clinical research, study design, biostatistics, regulatory environment, and medical terminology preferred • Ability to comply with company and/or industry style guides and templates • Excellent attention to detail regarding consistency, grammar, syntax, and scientific accuracy • Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems • Proficiency in Microsoft Outlook, Excel, and PowerPoint • Ability to prioritize multiple projects and complete high-quality documents under tight timelines • Strong project management and problem-solving skills • Ability to work collaboratively and coordinate communications and reviews

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness