[Hiring] Senior Document Specialist @BeiGene

Role 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.

• 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.

Requirements

• 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 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.
• 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

• 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.

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

Equal Opportunity Employer

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.

Accommodation

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 [email protected].