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.
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 (content‑wise/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.
Supervisory Responsibilities
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.
Education/Experience Required
MS with a minimum of 4+ years of regulatory document writing (or equivalent) experience.
PhD/PharmD/MD with a minimum of 2 years of regulatory document writing (or equivalent) experience.
An advanced degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related science is preferred.
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
Salary Range: $116,300.00 - $156,300.00 annually
BeiGene 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 BeiGene 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 and we value diversity. BeiGene 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.
