Senior Document Specialist

BeOne Medicines USA; Texas; Híbrido; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

BeOne Medicines USA seeks a Senior Document Specialist to oversee appendices in Veeva Vault, ensuring regulatory submissions meet ICH and FDA requirements within tight timelines. The role involves coordinating with Medical Writers and other teams, performing quality checks, and supporting SOP updates.

The position can be remote or based in BeOne offices, with ongoing training in medical writing and drug development to strengthen expertise in regulatory science.

Formación

• Masters degree or BA/BS plus 2+ years of relevant industry experience; or 5+ years of on-the-job training in pharmaceutical/biotech.
• BA/BS degree; Masters, PhD/PharmD, or other graduate-level degree is a plus.
• Proven ability to manage projects, present to stakeholders, and lead meetings.

Responsabilidades

• Create binders containing high-quality, scientifically accurate documents per ICH requirements under tight timelines.
• Ensure compliance with Medical Writing conventions, processes, and regulatory guidelines.
• Manage appendices collection timelines and coordinate with Medical Writers and cross-functional teams.
• Work in Veeva Vault to import/export, initiate and approve workflows, and perform related tasks.
• Perform quality check and approval of appendices documents.
• Assist Medical Writers with SOP or WI updates and author documents within the DS scope.
• Engage in trainings to increase knowledge of medical writing and drug development.

Conocimientos

Project management

Regulatory knowledge

English proficiency

Multitasking

Teamwork

Educación

Masters degree

BA/BS + 2+ years

5+ years pharma/biotech

Herramientas

Veeva Vault

Microsoft Word

Microsoft Excel

PowerPoint

Adobe Acrobat

SharePoint

Descripción del empleo

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 escalated 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.

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

Global Competencies