医学写作主管
Director, Medical Writing
**关于该职位：**
作为西海岸中心的医学写作总监，您负责根据治疗领域、疾病状态和/或开发阶段，在组合层面撰写和/或管理复杂的上市和开发项目。您还负责直接监督医学写作项目负责人，包括对内部跨职能团队和外部开发合作伙伴可能存在的医学写作问题作出响应。您将为部门的长期发展战略做出贡献，并确保在项目内外遵循标准流程。您将协调项目的优先级，在某些情况下，代表医学写作部门参加与治理委员会、监管机构和外部开发合作伙伴的会议。在制药/生物技术行业进行外部联系，以保持对不断演变/新兴行业标准的了解，并在公司内建立医学写作的最佳实践。
**您将负责：**
- 具备知识并能够独立准备临床和监管文件及文件包：方案及修订版、总结报告、研究者手册、IND/CTA、提交文件。深入了解行业最佳实践，能够战略性地设计文件，满足其目的，同时考虑到公开披露要求。
- 根据ICH指南、公司SOP、模板和监管要求，领导文件的规划、开发和交付。支持文件开发SOP和模板的开发与维护。
- 能够批判性地分析和综合复杂的科学信息，确保文件的科学准确性和一致性。制定并整合信息和医学写作策略，确保在治疗领域和/或疾病状态下文件的一致性。
- 与跨职能专家（包括但不限于）临床开发、法规事务、生物统计学、药物警戒、临床运营合作。
- 参与监管提交计划、时间表和文件开发。
- 管理和/或监督内部和/或承包商/供应商的医学作者，确保高质量的交付成果。指导和提供初级作者的职业发展建议。可能担任一个或多个功能服务提供商（FSP）的医学写作联络人。
- 为直属下属提供指导和职业发展，以打造一个高效、专业的团队。
查看英文原文
**About This Role:**
As the Director of Medical Writing for the West Coast Hub you are responsible for the writing and/or managing complex marketed and development programs at the portfolio level based on Therapeutic Area, disease state, and/or phase of development. You are also responsible for providing direct supervision for the Medical Writing program leads, including response to potential Medical Writing issues with internal cross-functional teams and external development partners. You will contribute to the long-term growth strategy of the department and ensure that standard procedures are followed across and within projects. You will synchronize prioritization of projects and in some cases, he/she represents Medical Writing in meetings with governance committees, regulatory agencies, and external development partners. Performs outreach within pharmaceutical/biotech industry to maintain knowledge of evolving/emerging industry standards and to establish medical writing best practices within company.
**What You’ll Do:**
- Have the knowledge and be independently able to prepare clinical and regulatory documents and packages: protocols and amendments, CSRs, IBs, INDs/CTAs, submissions.Thorough understanding of industry best practices to strategically design documents that fulfil their purpose but written with public disclosure requirements in mind.
- Lead the planning, development, and delivery of documents according to ICH guidelines, company SOPs, templates, and regulatory requirements.Support the development and maintenance of SOPs and templates for document development.
- Ability to critically analyze and synthesize complex scientific information, and ensure scientific accuracy and consistency of documents.Develop and integrate messaging and medical writing strategy and ensure consistency through documents in a therapeutic area and/or disease state.
- Collaborate with cross-functional SMEs including (but not limited to), Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, Clinical Operations.
- Participate in regulatory submission planning, timelines, and document development.
- Manage and/or provide oversight of in-house and/or contractor/vendor medical writers, ensuring high-quality deliverables.Mentor and provide professional development guidance to junior writers. May serve as the MW liaison for one or more Functional Service Providers (FSP)
- Provide mentoring and career development to direct reports to create a high-quality and productive group.
- Review statistical analysis plans and clinical data reports that are incorporated in data-related documents (CSRs, IBs, etc).Provide strategic input to TFL outputs to streamline TFL production.
- Lead departmental initiatives as necessary.
**Who You Are:**
In addition to having exceptional written and communication skills, you successfully worked in a matrix environment where you collaborated with other clinical teams. You have strong regulatory writing experience and strong teamwork capabilities.You have expert knowledge of global requirements related to all aspects of clinical regulatory documentation to support all phases of clinical development (Phase 1-4), and acts as a medical writing subject matter expert to other departments. You have a demonstrated management, scientific, and customer-focused leadership skills.People management skill is nice to have but not must have.
**Required Skills**
- Minimum of BSc + 12 years’ experience in Medical Writing, or Advanced degree + 7 years’ experience in Medical Writing (pharmaceutical, biotechnology, or CRO setting)
- Experience with global regulatory submissions (e.g. BLA/NDA, MAA)
- Familiarity with eCTD format and relationships between documents.
- Familiarity with ICH, FDA, and EMA guidelines and regulations, as well as public disclosure requirements for documents.
- Proven experience authoring documents and leading teams through the authoring process.
- Strong project management skills with the ability to prioritize and manage multiple projects in a fast-paced environment.
- SME in MS Word, and proficiency in document management systems (Veeva, SharePoint).
- Experience in managing and/or mentoring other medical writers or external vendors preferred
Job Level: Management
**Additional Information**
The base compensation range for this role is: $191,000.00-$263,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families _physical, financial, emotional,_ and _social well-being_; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
**Why Biogen?**
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. [Read on](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.biogen.com%2Fresponsibility%2Fdiversity-inclusion.html&data=05%7C01%7Cdennis.mercier%40biogen.com%7C67adaf5a6edd4324716208db0dcd2182%7C7b7466bbfe1d47a0b9438ded565c8e54%7C0%7C0%7C638118946897044815%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=p2vFGx6ZWK7lyBEL4wuNIQJcKSVRZD90VuJxcOkjX04%3D&reserved=0) to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.