Role Description
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.
This 1-year 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 BeOne pipeline with support from line manager/mentor.
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Clinical and regulatory documents include, but are not limited to:
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Clinical study protocol
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Investigator brochures
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Clinical study reports
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Clinical modules of IND submissions
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Essential Functions of the Job:
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Document Writing:
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Manages the assigned writing tasks and ensures that the documents adhere to relevant regulatory guideline(s), as well as BeOne SOP/WI(s), template(s), and style guide.
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Be able to manage multiple documents at the development of complex documents (e.g., those with complex content, urgent timeline, or external collaboration) in collaboration with cross-functional teams.
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Contributes to direction and strategy setting (including critically analyzing, synthesizing, and presenting complex information) for document development in collaboration with study team(s).
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Provides feedback regarding available document writing template/guidance for the document types with experience.
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Project/Program Management:
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Develops and manages timelines of individual documents.
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Manages uncertainties and changes to timelines.
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Identifies questions/issues that require departmental or team discussion.
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Identifies potential risks and proposes resolutions for problems.
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Builds connection with study team(s).
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Process/Tool Establishment and Optimization:
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Identifies needs for process/tool optimization and establishment.
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Provides feedback regarding available departmental process/tool related to own work.
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Training and Mentoring:
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Participates in and provides feedback regarding available training programs.
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Influence:
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Understands the global MW scope and works to guide study team(s) within the defined scope and responsibility following established processes.
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Provides insight on global MW deliverables and related knowledge within the department.
Qualifications
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An advanced degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related science by July 2027.
Requirements
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Effective Communication:
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Explains own work clearly.
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Escalates questions/issues to appropriate stakeholders at an early stage.
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Takes part in discussions with different viewpoints and provides value-added inputs.
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Embracing Change:
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Always seeking and open to new opportunities and changes.
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Copes well with change and new challenges.
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Provides feedback regarding specific change activities.
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Creating Innovation:
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Demonstrates openness to innovation and applies new ways of working (e.g., skills or techniques) in own work.
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Provides feedback regarding innovative ideas and new approaches.
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Thinking Strategically:
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Understands key concepts (e.g., strategic review, lean writing) related to own work.
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Demonstrates awareness of company strategies and general events happening in the industry (e.g., regulations, guidelines, and trends).
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Mentoring:
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Provides specific feedback to others within own team as requested.
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Computer Skills:
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Technical expertise in Microsoft Word, Adobe Acrobat.
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Proficiency in Microsoft Outlook, Excel, and PowerPoint.
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Travel: On occasion, as needed.
Benefits
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Pay Rate: 75K/Year
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All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock.
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Comprehensive benefits package includes:
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Medical
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Dental
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Vision
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401(k)
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FSA/HSA
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Life Insurance
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Paid Time Off
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Wellness