Senior Document Specialist

BeOne Medicines Ltd.; Austin (TX); Remote; USD 80,000 - 110,000; Full time

Job summary

BeOne Medicines Ltd. is seeking a Senior Document Specialist to oversee appendices for regulatory submissions using Veeva Vault, ensuring compliance with FDA and ICH guidelines.

The role can be remote or based in BeOne’s offices, with cross-functional collaboration within Global Medical Writing to produce high-quality, compliant documents under tight timelines. You will manage collection timelines, perform quality checks, and support Medical Writers in SOP/WI updates, while developing your

Qualifications

• Demonstrated ability to communicate in clear, concise, and effective English (both written and verbal).
• Familiarity with regulatory submission requirements (FDA and ICH) is essential.
• Experience coordinating documents and workflows within pharmaceutical/biotech environments.

Responsibilities

• Coordinate and collect appendices documents in Veeva Vault for regulatory submissions.
• Ensure compliance with FDA/ICH guidelines and Medical Writing conventions.
• Manage appendices collection timelines and communicate with Medical Writers and cross-functional departments.
• Operate within Veeva Vault to import/export, initiate and approve workflows.
• Perform quality checks and approvals of appendices documents.
• Assist Medical Writers with SOP/WI updates or author documents as part of the DS scope.
• Participate in trainings to expand knowledge of medical writing and drug development.

Skills

Clear English communication

Project management

Prioritization under tight timelines

Attention to detail

Team collaboration

Problem solving

Education

Masters degree

BA/BS + 2+ years pharma/biotech

PharmD/PhD/MS as a plus

Tools

Veeva Vault

Microsoft Word

Excel

Adobe Acrobat

SharePoint

Job description

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 escape 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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.