General Description:

一般说明：

Develop high-quality clinical documents (Phase 1 to Phase 4 globally or locally) timely for submission to regulatory authorities. Clinical regulatory documents, including but not limited to: clinical study protocols and amendments, investigator brochures, clinical study reports, regulatory briefing documents, and clinical sections of INDs, NDAs, MAAs and other regulatory submission documents.

撰写高质量的临床文档（全球或本地的1期到4期），及时提交给监管机构。临床注册文件，包括但不限于：临床研究方案和修订案、研究者手册、临床研究报告、注册简报文件以及IND、NDA、MAA和其他注册递交文件的临床部分。

Essential Functions of the Job:

基本工作职能：

•Works effectively with cross-functional groups to produce high-quality, scientifically accurate documents under strict timelines, and ensures consistency between related documents.

•与跨职能部门有效合作，在严格的时间范围内撰写高质量、科学准确的文档，并确保相关文档之间的一致性。

•Develop and manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables.

•制定和管理时间表，并与团队成员进行沟通，以保持团队成员对预期、里程碑和可交付成果的知晓。

•Ensure clinical documents adhere to BeiGene standards and regulatory guidelines.

•确保临床文件符合百济神州标准和法规指南。

•Ensure that assigned documents undergo a quality check before approval, and that documents are routed correctly during review and approval cycles.

•确保分配的文档在批准之前经过质量检查，并且在审阅和批准周期内正确处理文档。

•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.

•确保团队确定的关键信息在文件中清晰、充分地体现出来；在意见冲突的情况下，促使团队达成一致意见。

•Establish effective cross-functional communication and relationships with stakeholders both internally and externally.

•与内部和外部的利益相关方建立有效的跨职能沟通和关系。

•Create/maintain/optimize templates and corresponding instructions.

•创建/维护/优化模板和相应的说明

•Participate in departmental or interdepartmental process improvement and training initiatives.

•参与部门或部门间的流程改进和培训计划。

•Mentor and manage entry-level FTE writers as needed.

•按需指导和管理刚入门的全职撰稿人。

•Enhance medical writing’s exposure and influence internally as needed.

•按需提高医学写作部门的曝光率和内部影响力。响力。

Qualification:

胜任要求

•Minimum requirement of a master’s degree of life science/pharmacy/ nursing/medical/health related science or equivalent; PhD/PharmD in life sciences preferred

•最低要求为生命科学/药学/护理/医学/健康相关理学硕士学位；生命科学理学博士学位/药学博士学位优先。

•Accumulated at least 2 years of relevant industry experience as a regulatory medical writer

•积累了至少2年的注册医学撰稿相关行业经验。

•Demonstrated ability to communicate and write English clearly, concisely, and effectively

•拥有清晰、简洁、有效的英文交流和撰写能力。

•Good interpersonal skills; a team player

•良好的人际交往技能；有团队精神

•Ability to coordinate and manage communications to enable timely reviews from other authors and reviewers and to function as a collaborative team member

•能够协调和管理沟通，以使其他作者和审阅者能够及时进行审阅，并能够作为协作团队成员发挥作用

•Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner

•能够理解和解读临床和科学数据；能够以可理解的方式呈现结果

•Ability to complete high-quality documents according to tight timelines

•能够根据紧迫的时限完成高质量的文档

•Ability to comply with company and/or industry style guides and templates

•能够遵守公司和/或行业风格指南和模板

•Good project management skills

•良好的项目管理能力