Medical Writing Fellow

BeiGene

7d • Onsite

About The Position

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. The clinical and regulatory documents include, but are not limited to, clinical study protocol, investigator brochures, clinical study reports, and clinical modules of IND submissions.

Requirements

• An advanced degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related science by July 2027.
• Technical expertise in Microsoft Word, Adobe Acrobat; proficiency in Microsoft Outlook, Excel, and PowerPoint, etc.

Responsibilities

• 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.
• Be able to manage multiple documents at the development of complex documents (eg, those with complex content, urgent timeline, or external collaboration) in collaboration with cross-functional teams.
• Contributes to direction and strategy setting (including critically analyzing, synthesizing, and presenting complex information) for document development in collaboration with study team(s).
• Provides feedback regarding available document writing template/guidance for the document types with experience.
• Develops and manages timelines of individual documents.
• Manages uncertainties and changes to timelines.
• Be able to identify the questions/issues that require departmental discussion or team discussion.
• Be able to identify the potential risks.
• Proposes resolutions for problems.
• Builds connection with study team(s).
• Identifies needs for process/tool optimization and establishment.
• Provides feedback regarding available departmental process/tool related to own work.
• Participates in and provides feedback regarding available training programs.
• Understands the global MW scope and works to guide study team(s) within the defined scope and responsibility following established processes.
• Provides insight on global MW deliverables and related knowledge within the department.
• Explains own work clearly.
• 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 value-added inputs.
• Always seeking and open to new opportunities and changes.
• Copes well with change and new challenges.
• Provides feedback regarding specific change activities.
• Demonstrates openness to innovation and applies new ways of working (eg, skills or techniques) in own work.
• Provides feedback regarding the innovative ideas and new approaches and uses them to tackle own work tasks and issues in a better way.
• Understands key concepts (eg, strategic review, lean writing) related to own work.
• Demonstrates awareness of company strategies and general events happening in the industry (eg, regulations, guidelines, and trends).
• Provides specific feedback to others within own team as requested.

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness
• annual bonus plan
• discretionary equity awards
• Employee Stock Purchase Plan

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level