About Us
BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).
BeiGene 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.
Job Description
General Description:
This position is responsible for providing expertise to support the development of high-quality, fit-for-purpose clinical and regulatory documents to facilitate speed of information during development, submission, approval, and life-cycle management of products in BeiGene pipeline. The clinical and regulatory documents include, but are not limited to, clinical study protocols, investigator brochures, clinical study reports, regulatory briefing documents, and clinical modules of INDs, NDAs, BLAs, MAAs and other regulatory submissions. This position is also responsible for mentoring junior MWs (full-time employees and/or contractors/vendors) as needed.
Document Writing
Essential Functions of the Job:
- Manages the assigned writing tasks and ensures that the documents adhere to relevant regulatory guideline(s), as well as BeiGene SOP/WI(s), template(s), and style guide.
- Be able to manage multiple documents at the same time, including the complex documents (eg, those with complex content, urgent timeline, or external collaboration). Leads direction and strategy setting (including critically analyzing, synthesizing, and presenting complex information) for document development in collaboration with study team(s), and be able to help other MWs as requested.
- Contributes to the creation of document writing template/guidance for the document types listed in the General Description part. Leads part of the maintenance of document writing template/guidance for the document types listed in the General Description part.
Project /Program Management
- Navigates through uncertainties to develop and manage timeline of individual documents and multiple documents (supported by different MWs in one project, eg, works as the MW filing lead for an NDA/BLA/MAA submission). Be able to help other MWs as requested.
- Be able to identify the questions/issues that require departmental discussion or team discussion. Be able to identify the potential risks, make a mitigation plan, and work to resolve problems. Be able to help other MWs in these areas as requested.
- Builds relationship with study team(s) and program team(s) (eg, works as the MW program lead).
- Understands the role of own documents within the larger dossier and voices out any impact on upstream and downstream processes. Be able to help other MWs as requested.
Process/Tool Establishment And Optimization
- Proactively identifies needs for process/tool optimization and establishment, and proposes solutions.
- Leads part of departmental process/tool optimization. Contributes to departmental process/tool establishment.
- Contributes to cross-functional and cross-company process/tool optimization.
Training And Mentoring
- Leads (part of) the development of new training programs. Provides instructions/trainings (contentwise/process-wise) to junior MWs.
- Provides technical and operational mentorship to junior MWs (full-time employees and/or contractors/vendors).
Influence
- Understands the global MW scope and works to guide study team(s) and program team(s) within the defined scope and responsibility following established processes.
- Provides topic sharing on regulatory writing and related knowledge within the department (and to cross-functional stakeholders with guidance from line manager/mentor).
- Provides topic sharing on regulatory writing and related knowledge across companies (eg, meetings of DIA and medical writing communities) with guidance from line manager/mentor.
Qualification Required
Education Required:
- An advanced degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related science is preferred.
- MS with a minimum of 5 years of regulatory document writing (or equivalent) experience.
- PhD/PharmD/MD with a minimum of 2 years of regulatory document writing (or equivalent) experience.
Other Qualifications
- Effective Communication: Articulates information clearly, explaining complex information effectively and confidently in presentations to others. Be able to escalate questions/issues to appropriate stakeholders at an early stage. Takes part in discussions with different viewpoints, and be able to provide valueadded inputs.
- Embracing Change: Always seeking and open to new opportunities and changes. Willing to explore new and different solutions when faced with new challenges. Appreciates the need for change, addressing ambiguous or uncertain situations directly. Leads part of change efforts management within the department.
- Creating Innovation: Demonstrates the willingness to change perspectives and ideas that are no longer relevant and learn new skills or techniques. Generates innovative ideas that have the potential to provide effective alternative methods of working for self and others.
- Thinking Strategically: Understands how concepts (eg, strategic review, lean writing) relate to the future objectives and aims of the department, and actively applies principles (eg, best practices for strategic review, lean writing). Understands company strategies and general events happening in the industry (eg, regulations, guidelines, and trends), and knows how they impact the department.
- Mentoring: Provides feedback related to individual and group to support ongoing development and group performance as needed. Invests time and effort to provide instructions for junior MWs.
Computer Skills
Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel, and PowerPoint, etc.
Travel
On occasion, as needed.
What We Offer To Our Valued Employees
- Market competitive compensation package including performance-based annual bonus scheme
- Company shares (generous welcome grant and performance-based annual equity plan!)
- In-house and external learning and development opportunities
- Fantastic benefits program and keep improving!
- Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
- Join us and Make momentum in your career!
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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
BeiGene is committed to respect and protect personal information rights of job applicants and will process job applicants personal information in accordance with applicable laws and regulations.
Due to BeiGene's global operation, job applicants data will be stored overseas with adequate protection. Besides, job applicants data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeiGene. For further details, please refer to BeiGene's Job Applicant Privacy Policy (https://www.beigene.com/privacy-policy).
If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeiGene's Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeiGene's Job Applicant Privacy Policy as well as the relevant privacy terms.
If you have any concern, please DO NOT provide any resume or other personal information to us. 
