Principal Med Writer
工作标题：主任 Med 作家职位位置：远程，印度工作地点类型：远程工作合同类型：全日制工作资深级别：工作时间表标准 （月-周五）环境条件办公室工作描述从规划和协调提供高质量的医学和科学写作，通过向内部和外部客户交付最终稿件。作为主要作者，他对团队的文件进行审查，并为年轻团队成员提供培训和指导。在文档开发战略，法规和行业最佳实践上提供建议。展示了主题和治疗领域专业知识。担任备份项目经理。协作与内部和外部客户，支持并实现有效和高效的沟通，从而导致运营卓越。研究，撰写和编辑临床研究报告和研究协议，并总结临床研究数据。研究，编写和编译临床研究的报告和研究协议以及总结临终研究数据。· 作为主要作者，他撰写并提供复杂的临床和科学和项目级文档，包括 IBs,INDs 和 MAA. · 提供高级层次审查常规和复杂文件。提供其他作家和项目经理在文件编制，使用软件开发，文档类型，监管要求以及治疗领域知识方面的培训和指导。·确保对分配的文件质量流程和要求的遵守。作为主题专家，制定并审查最佳结果实现的最佳实践，方法和技术，包括各种客户特定过程，并领导进程改进倡议。还可以为指定项目的性能衡量标准进行开发，审查和管理。· 可以担任备份计划经理。识别和解决范围之外的活动。职责可能包括制定时间表，预算，预测和合同修改，并协助业务发展通过客户介绍和提案文本审查以及参加投标辩护会议和能力演示。·代表部门在项目启动会议，审核会议和项目团队会议上。该工作由 Lifelancer 主办.Lifelancers 是一个人才招聘平台生命科学，药物和 IT 领域。该平台将人才与医疗，生物技术，卫生科学，健康科技和 IT 等领域的机会联系起来。
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Job Title: Principal Med Writer
Job Location: Remote, India
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. As the lead writer, reviews documents for the team and provides training and guidance to junior team members. Provides advice on document development strategy, regulations and industry best practices. Demonstrates subject matter and therapeutic area expertise. Acts as backup program manager. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.
Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies.
Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies.
- Serves as primary author who writes and provides input on complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
- Provides senior level review of routine and complex documents. Provides training and mentorship for other writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
- Ensures compliance with quality processes and requirements for assigned documents. As the subject matter expert, develops and reviews best practices, methods and techniques for achieving optimal results, including various client-specific processes, and leads process improvement initiatives. May also develop, review and manage performance metrics for assigned projects.
- May serve as backup program manager. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications, and assisting business development with client presentations and proposal text review and attending bid defense meetings and capabilities presentations.
- Represents the department at project launch meetings, review meetings, and project team meetings.
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Originally posted on Himalayas