医学写作协调员/出版商 I
Medical Writing Coordinator/Publisher I
关于艾伯维
艾伯维的使命是发现和提供创新药物和解决方案，解决当前严重的健康问题，并应对未来的医疗挑战。我们致力于在免疫学、肿瘤学和神经科学等多个关键治疗领域对人们的生活产生重大影响，以及我们在Allergan Aesthetics产品组合中的产品和服务。有关艾伯维的更多信息，请访问我们的网站 www.abbvie.com。关注我们在 LinkedIn、Facebook、Instagram、X 和 YouTube 上的账号。
医学撰写协调员/发布员 I 是战略医学撰写运营团队的一部分，致力于提供高质量、科学准确且与战略一致的临床和监管文件，支持艾伯维将护理标准转变为现实的使命。我们的团队是在研究、开发和监管提交之间的重要纽带，确保所有临床和监管文件的清晰度和合规性。我们通过跨职能协作、敏捷方法和尖端技术的整合，不断创新并改进医学撰写的流程，推动艾伯维在全球改善患者结果的承诺。
职责：
· 与文件作者定义格式化、报告发布和临床研究报（CSR）附录活动的范围。协调并跟踪活动，执行详细的质量审查。在监管信息管理系统（RIMS）中导入并传递文件。
· 确保文件格式和样式符合 RIMS 中定义的标准，并与临床和监管模板保持一致。确保使用文件属性和命名规范。维护对 RIMS 样式和格式标准的深入了解。
· 确保所有文件在 RIMS 内容管理系统中按时发布。维护对 RIMS 和发布工具/软件的深入了解。
· 通过获取、汇编和组织在监管信息管理系统（RIMS）中的文件（例如病例本、文献参考），确认文件的完整性。维护对 CSR 和 CSR 附录以及 CTD 结构的深入了解。
· 参与医学撰写运营业务流程的开发、实施和维护。作为主文件系统和格式、报告发布或临床研究报（CSR）附录的专家（SME）为医学撰写团队提供支持。
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About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
The Medical Writing Coordinator/Publisher I part of the Strategic Medical Writing Operations Team is dedicated to delivering high-quality, scientifically accurate, and strategically aligned clinical and regulatory documentation that supports AbbVie's mission to transform the standard of care. Our team serves as a critical link between research, development, and regulatory submissions, ensuring clarity and compliance in all clinical and regulatory documents. We strive to innovate and enhance the processes of medical writing through cross-functional collaboration, agile methodologies, and the integration of cutting-edge technology, driving forward AbbVie's commitment to improving patient outcomes worldwide.
Responsibilities:
· Defines scope of formatting, report publishing and Clinical Study Reports (CSR) Appendices activities with the document author. Coordinate and track activities and perform detailed quality reviews. Import and route documents in the regulatory information management systems (RIMS).
· Ensure document format and styles are consistent with the defined in RIMS and are consistent with the clinical and regulatory templates. Ensure document properties and naming conventions are used. Maintain strong knowledge of RIMS styes and formatting standards.
· Ensures all documents are published in RIMS content management system meet required timelines. Maintain strong knowledge of RIMS and publishing tools/software.
· Confirm completeness of documents (e.g. Casebooks, Literature References) by obtaining, compiling, and organizing in the regulatory information management system (RIMS). Maintain strong knowledge of CSR and CSR Appendices and CTD structure.
· Contributes to the development, implementation, and maintenance of medical writing operations business processes. Acts as subject matter expert (SME) for the master file system and formatting, report publishing, or Clinical Study Reports (CSR) Appendices to the medical writing stakeholders.
· Effectively communicates deliverables needed to stakeholders. Must demonstrate good interpersonal and organizational communication skills, including conflict management skills.
· Assists in the management of the centralized mailbox. Tracks and maintains metrics and assists in the preparation and maintenance of training documents.
· Mentors and provides guidance and training to less senior medical writing operations staff members.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.
- High School diploma required. Note: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.
- A minimum of 2 years of relevant industry experience within medical writing in a global pharma, biotech, life science, federal agency organization delivering medicines/ therapies to a broad market across various therapeutic areas.
- Background of organization and content of clinical documents and eCTD structure. Knowledge of drug development and experience with Common Technical Document (CTD) content templates.
- Outstanding written and oral communication skills, with a comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas.
- Detail oriented with a commitment to delivering high quality, accurate and compliant documentation.
- Strong communication, collaboration, and organizational skills.
- Ability to work independently and as part of a team. Ability to work independently and as part of a team.
- Proficient skills and knowledge in Microsoft Office Products (Excel, OneNote, Outlook, PowerPoint, Project, SharePoint, Visio, Word) and Adobe in Windows operating system environment required. Proficient skills and knowledge in Microsoft document file formats (DocX) or other style file format tools, publishing software, and content management archival system(s) for eTMF/eSubmissions (Veeva Vault, CARA). Proficient skills and knowledge in reference management software (e.g., EndNote).
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
· The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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