{"id":3498363,"url":"https://alion.io/job/beone-medicines-senior-document-specialist","title":"Senior Document Specialist","company":{"id":99686,"name":"BeOne Medicines","domain":"beonemedicines.com","url":"https://alion.io/company/beonemedicines","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":79,"open_postings":19,"ghost_share":0,"stale_share":0.842,"repost_share":0,"time_to_fill_p50_days":41,"computed_at":"2026-11-01T06:10:25Z"}},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":82100,"max":112100,"currency":"USD","period":"year","gross":null,"usd_annual":112100},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"Veeva","optional":false},{"name":"Outlook","optional":true},{"name":"SharePoint","optional":true},{"name":"Windows","optional":true}],"status":"live","first_seen_at":"2026-10-29T00:00:00Z","employer_posted_date":"2026-10-29","last_verified_at":"2026-11-01T18:54:53Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.\nGeneral Description:\nThe Senior Document Specialist is responsible for the oversight, coordination, and collection of appendices documents within Veeva Vault that are submitted to regulatory authorities along with clinical study reports in a manner that conforms to domestic and/or international regulatory submission and internal document standards, while meeting project timelines.\nThis work can be done remotely, or from any of BeOne’s global offices.\nEssential Functions of the Job:\nWork effectively within the Global Medical Writing department to create binders containing high-quality, scientifically accurate documents as per ICH requirements under strict timelines.\nEnsure compliance with Medical Writing conventions, processes, and applicable regulatory guidelines.\nManage appendices collection timelines and communicate with Medical Writers and cross-functional departments to maintain awareness of expectations, milestones, and deliverables.\nWorks actively in the Veeva Vault environment to import, export, initiate workflows and approve workflows, and perform other tasks as needed within the Report Level Content Plan.\nResponsible for performing quality check and approval of appendices documents.\nMay act as the Document Coordinator to assist Medical Writers in SOP or WI updates or author documents designated as part of the DS scope.\nEngage in trainings that will increase knowledge of medical writing, the types of documents in the scope of the GMW team, and the development of drugs and biologics.\nQualifications:\nDemonstrated ability to communicate in clear, concise, and effective English (both written and verbal).\nAbility to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines and shifting priorities/demands.\nA thorough understanding of the key requirements for regulatory submissions as defined in FDA regulations and ICH guidelines.\nFamiliarity with the development of drugs and biologics (ie, clinical study design, biostatistics, regulatory affairs, and medical terminology) is preferred.\nExperience managing projects, giving presentations, and leading meetings.\nIndependently motivated with good problem-solving skills.\nExcellent interpersonal skills; is self-aware, acts inclusively, and consistently prioritizes teamwork.\nSupervisory Responsibilities:\nNone.\nEducation Required:\nMasters 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 a pharmaceutical or biotech industry.\n BA/BS degree; Masters, PhD/PharmD, or other graduate-level degree is a plus.\nOther Qualifications:\nEffective Communication: Confidently presents the issues related to own work to others. Be able to escalate questions/issues to appropriate stakeholders at an early stage, with guidance from line manager/mentor. Takes part in discussions with different viewpoints, and be able to provide value added- inputs.\nEmbracing Change: Always seeking and open to new opportunities and changes. Willing to explore new and different solutions when faced with new challenges. Copes well with change and new challenges, recognizing the benefits for self and the department. Contributes to specific change activities.\nCreating Innovation: Demonstrates the willingness to change perspectives and ideas that are no longer relevant and learn new skills or techniques. Proposes innovative ideas and suggests new approaches to tackle own work tasks and issues in a better way.\nThinking Strategically: Understands how concepts (eg, strategic review, lean writing) relate to own work, and applies principles (eg, best practices for strategic review, lean writing) when appropriate. Understands company strategies and general events happening in the industry (eg, regulations, guidelines, and trends), and knows how current and emerging trends affect own role.\nMentoring: Provides constructive, behaviorally-oriented feedback to others within the team as requested. Willingly shares own knowledge and experience to support others’ learning.\nComputer Skills:\nTechnical expertise in Microsoft Word, Microsoft Outlook, Excel, PowerPoint, and Adobe Acrobat. Working knowledge of electronic document management systems.\nProficiency in navigating Microsoft Windows and Veeva Vault.\nFamiliarity with SharePoint file systems is a plus.\nTravel:\nOn occasion, as needed.\nGlobal Competencies\nWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.\nFosters Teamwork\nProvides and Solicits Honest and Actionable Feedback\nSelf-Awareness\nActs Inclusively\nDemonstrates Initiative\nEntrepreneurial Mindset\nContinuous Learning\nEmbraces Change\nResults-Oriented\nAnalytical Thinking/Data Analysis\nFinancial Excellence\nCommunicates with Clarity\nSalary Range: $82,100.00 - $112,100.00 annuallyBeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.\nWe are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact .","description_format":"text","description_chars":7188,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":["Continuous learning","Equity","Life insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Biologics & Biosimilars","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-30T02:36:59Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 30","filings_12m":30,"filings_prev_12m":14,"green_card_filings_12m":0,"median_offered_wage_usd":187500,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":3,"expected_fill_days":41,"reasons":["conf:2","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-11-01T06:10:25Z"},"pay":{"stated_usd_annual":112100,"is_top_pay":false},"html_url":"https://alion.io/job/beone-medicines-senior-document-specialist","json_url":"https://alion.io/job/beone-medicines-senior-document-specialist.json","meta":{"generated_at":"2026-11-02T02:24:56Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":3619,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-03T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":99686},"rest":"https://alion.io/mcp/rest/get_company?id=99686"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbeone-medicines-senior-document-specialist"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fbeone-medicines-senior-document-specialist"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fbeone-medicines-senior-document-specialist"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/beone-medicines-senior-document-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbeone-medicines-senior-document-specialist"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3498363}},{"tool":"search_jobs","arguments":{"company":"beonemedicines.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3498363},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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