Senior Medical Writer

About the role

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 protocol, investigator brochures, clinical study reports, clinical modules of IND submissions, and clinical modules for NDAs, BLAs, MAAs and other regulatory submissions (eg, clinical summaries and bridging study evaluation report).

Responsibilities

• 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).
• Contributes to direction and strategy setting (including critically analyzing, synthesizing, and presenting complex information) for document development in collaboration with study team(s).
• Contributes to the creation and maintenance of document writing template/guidance for the document types listed in the General Description part.
• Navigates through uncertainties to develop and manage timeline of individual documents.
• Be able to identify the questions/issues that require departmental discussion or team discussion with guidance from line manager/mentor.
• Be able to identify the potential risks and make a mitigation plan with guidance from line manager/mentor.
• Resolves problems with guidance from line manager/mentor (eg, takes concrete actions according to