Regulatory Writing Senior Manager
职业类别**监管## **工作描述** **你如何挑战想象力？** 如果你觉得自己是更大的东西的一部分，那是因为你。在阿姆根，我们共同的服务患者使命驱动着我们的一切工作。这对我们成为世界领先的生物技术公司之一至关重要。我们是全球合作伙伴，共同研究，制造和提供越来越好的产品，达到全世界超过1000万患者。现在是你可以自豪的职业生涯的时候了。####监管书写高级经理### **Live** **What you will do** Let's do this.Let's change the world. 在这个关键角色中，你将担任产品团队的功能领域领导者，为复杂的产品提交提供内容负责写作活动，提供功能领域专业知识，培训和指导更多年轻作家，以及主管部门的活动。主要责任包括：- 作者或监督所有监管提交文件的编制，包括临床研究报告，调查人员小册子，对问题的回答，协议，议定书修改，信息同意表格，所有研究表格，临床概述附加，eCTD 模块2临床总结文档，简报文档和儿科调查计划 - 按照适用的标准操作程序进行作者文件的正式审查和批准- 在有限监督下，负责复杂产品提交的监管性写作活动，包括新药申请/生物学许可申请- 在产品团队担任功能领域领导 （例如全球监管团队，证据生成团队，全球安全团队，标签工作组）- 为全球监管计划和团队目标提供功能区域输入 - 监督合同和自由职作家以及经过分配的初级医学作家的工作 - 根据适当情况，领导部门和跨部门倡议。- 生成文件时间表## **Win** **我们对你的期望是什么** 我们都不同，但我们都利用我们的独特贡献来服务患者。我们寻求的是具有这些资格的领导者。### **基本资格：**博士学位和2年的直接相关经验或士学位和6年直接相关经历 OR 学士学位和8年的直接相关体验 OR 副业务学位和10年的直接相关专业经验
查看英文原文
### **Career Category**
Regulatory
### **Job Description**
**HOW MIGHT YOU DEFY IMAGINATION?**
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
### Regulatory Writing Senior Manager
### **Live**
**What you will do**
Let’s do this. Let’s change the world. In this key role you will serve as the functional area lead on product teams, lead writing activities for complex product submissions, provide functional area expertise, train and mentor more junior writers, and lead departmental activities. Key responsibilities include:
- Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
- Conduct the formal review and approval of authored documents, following applicable standard operating procedures
- With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
- Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
- Provide functional area input for Global Regulatory Plan and team goals
- Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
- Lead departmental and cross-departmental initiatives, as appropriate
- Generate document timelines
### **Win**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
### **Basic Qualifications:**
Doctorate degree and 2 years of directly related experience
OR
Master’s degree and 6 years of directly related experience
OR
Bachelor’s degree and 8 years of directly related experience
OR
Associate’s degree and 10 years of directly related experience
### Or
High school diploma / GED and 12 years of directly related experience
### **Preferred Qualifications:**
- Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
- 5+years of experience in medical writing in the Biotech/Pharmaceutical industry
### **Thrive**
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
### **Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
### **careers.amgen.com**
### Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
**Salary Range**
139,581.90USD -188,846.10 USD