· Works effectively with cross-functional groups to produce high-quality, scientifically accurate documents under strict timelines, and ensures consistency between related documents · Develop and manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables · Ensure clinical documents adhere to BeiGene standards and regulatory guidelines · Ensure that assigned documents undergo a quality check before approval, and that documents are routed correctly during review and approval cycles · Ensure the key messages as defined by the team are clearly and adequately represented in the documents; drive the team to reach agreement in case of conflicting opinions. · Establish effective cross-functional communication and relationships with counterparts both internally and externally. · Participate in departmental or interdepartmental process improvement and training initiatives. · Mentor and manage entry-level FTE writers as needed

Qualification

· Minimum requirement of a master’s degree of life science/pharmacy/ nursing/medical/health related science or equivalent; PhD/PharmD in life sciences preferred · More than 1 years of relevant industry experience as a regulatory medical writer · Demonstrated ability to communicate and write English clearly, concisely, and effectively · Excellent interpersonal skills; a team player · Ability to coordinate and manage communications to enable timely reviews from other authors and reviewers and to function as a collaborative team member · Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner · Ability to complete high-quality documents according to tight timelines · Ability to comply with company and/or industry style guides and templates · Strong project management skills · Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems

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