Senior Document Specialist

BeOne Medicines; Mountain Home (TX); À distance; USD 82 000 - 112 000; Plein temps

Résumé du poste

BeOne Medicines Ltd. is seeking a Senior Document Specialist to oversee appendices documents within Veeva Vault, coordinating submissions to regulatory authorities for clinical study reports.

The role can be performed remotely or from BeOne’s global offices, with emphasis on timely, accurate documentation in line with ICH and FDA requirements. You will work with the Global Medical Writing team to assemble binders, manage timelines, perform quality checks, and guidance on SOP updates.

Qualifications

• Masters degree or BA/BS plus 2+ years in pharma or biotech
• Experience with document management and regulatory submissions
• Strong English written and verbal communication
• Remote work or BeOne office-based work flexibility

Responsabilités

• Coordinate and collect appendices for regulatory submissions
• Ensure compliance with FDA/ICH guidelines
• Manage appendices timelines and liaise with Medical Writers and cross-functional teams
• Quality check and approve appendices documents
• Assist Medical Writers with SOP or WI updates in DS scope

Connaissances

English communication

Project management

Prioritization

Regulatory knowledge

Cross-functional collaboration

Problem-solving

Formation

Masters degree or BA/BS + 2+ years pharma/biotech

BA/BS + masters/PharmD/ PhD a plus

Outils

Veeva Vault

Microsoft Office

SharePoint

Description du poste

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.

General Description

• The 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.
• This work can be done remotely, or from any of BeOne’s global offices.

Essential Functions Of The Job

• Work effectively within the Global Medical Writing department to create binders containing high-quality, scientifically accurate documents as per ICH requirements under strict timelines.
• Ensure compliance with Medical Writing conventions, processes, and applicable regulatory guidelines.
• Manage appendices collection timelines and communicate with Medical Writers and cross-functional departments to maintain awareness of expectations, milestones, and deliverables.
• Works 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.
• Responsible for performing quality check and approval of appendices documents.
• May act as the Document Coordinator to assist Medical Writers in SOP or WI updates or author documents designated as part of the DS scope.
• Engage 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.

Qualifications

• Demonstrated ability to communicate in clear, concise, and effective English (both written and verbal).
• Ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines and shifting priorities/demands.
• A thorough understanding of the key requirements for regulatory submissions as defined in FDA regulations and ICH guidelines.
• Familiarity with the development of drugs and biologics (ie, clinical study design, biostatistics, regulatory affairs, and medical terminology) is preferred.
• Experience managing projects, giving presentations, and leading meetings.
• Independently motivated with good problem-solving skills.
• Excellent interpersonal skills; is self-aware, acts inclusively, and consistently prioritizes teamwork.

Supervisory Responsibilities

• None.

Education Required

• Masters 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.
• BA/BS degree; Masters, PhD/PharmD, or other graduate-level degree is a plus.

Other Qualifications

• Effective Communication: Confidently presents the issues related to own work to others. Be able to elevate 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.
• Embracing 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.
• Creating 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.
• Thinking 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.
• Mentoring: Provides constructive, behaviorally-oriented feedback to others within the team as requested. Willingly shares own knowledge and experience to support others’ learning.

Computer Skills

• Technical expertise in Microsoft Word, Microsoft Outlook, Excel, PowerPoint, and Adobe Acrobat. Working knowledge of electronic document management systems.
• Proficiency in navigating Microsoft Windows and Veeva Vault.
• Familiarity with SharePoint file systems is a plus.

Travel

• On occasion, as needed.

Global Competencies

When 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.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $82,100.00 - $112,100.00 annually

BeOne 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.

We 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 [e-mail].