Senior Document Specialist

Job not on LinkedIn

🔥 3 minutes ago

🤠 Texas – Remote

🤠 Texas – Remote

💵 $82.1k - $112.1k / year

⏰ Full Time

🟠 Senior

👻 Ghost score 1%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

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

• Oversee, coordinate, and collect appendix documents in Veeva Vault for submission to regulatory authorities with clinical study reports • Ensure documents conform to domestic and international regulatory submission and internal document standards • Create high-quality, scientifically accurate binders according to ICH requirements and strict timelines • Ensure compliance with Medical Writing conventions, processes, and regulatory guidelines • Manage appendix collection timelines and communicate expectations, milestones, and deliverables to Medical Writers and cross-functional departments • Import, export, initiate, and approve workflows in Veeva Vault within the Report Level Content Plan • Perform quality checks and approve appendix documents • Act as Document Coordinator for SOP or WI updates and author documents within the Document Specialist scope • Participate in training on medical writing, document types, and drug and biologic development • Work within the Global Medical Writing department

🎯 Requirements

• Demonstrated ability to communicate in clear, concise, and effective English, both written and verbal • Ability to prioritize tasks, manage multiple projects, and meet tight timelines and shifting priorities • Thorough understanding of regulatory submission requirements defined in FDA regulations and ICH guidelines • Familiarity with drug and biologic development, including clinical study design, biostatistics, regulatory affairs, and medical terminology preferred • Experience managing projects, giving presentations, and leading meetings • Good problem-solving skills and independent motivation • Excellent interpersonal skills, self-awareness, inclusivity, and teamwork • Required education: Master's degree; or BA/BS plus 2+ years of relevant industry experience; or 5+ years of on-the-job training and experience, including document management and process implementation, within pharmaceutical or biotech industry • Technical expertise in Microsoft Word, Microsoft Outlook, Excel, PowerPoint, and Adobe Acrobat • Working knowledge of electronic document management systems • Proficiency in Microsoft Windows and Veeva Vault • Familiarity with SharePoint file systems is a plus

🏖️ 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 benefits • Remote work option • Occasional travel as needed

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume