Associate Specialist, Global Submissions Publishing
职位描述 **职位标题**全球提交出版 (GSP) 的副专家 **部门**监管规划和发布 (RPP) **职位简介**包括监管内容管理和提交出版的全球提交出版，与各利益相关者密切合作，确保按全球监管卫生当局政策和技术要求以及电子/硬件提交内部指南及时完成提交组件和装配。**提交出版**负责向卫生当局汇编，链接和交付高质量的监管档案，促进与行业周期时间相一致的快速机构审查。_ 提交发布的主要责任：_ - **提交活动支持**:执行包括质量控制，验证，完成，递交文件和存储以确保符合行业标准和监管要求的全面发布过程。- **提前完成提交会议**: 确保所有文件都在规定的时间内完成并提交，以维持项目日程安排和实现组织目标。_ 分享责任：_ - **合作**:与作者，贡献者和利益相关者合作，以确保高质量的成果，提高项目的结果和推动集体成功。- **测试和实施新工具和流程**:参与新的出版工具和过程的测试和评估。提供反和建议改善以提高效率和有效性。- **管理文档开发**: 协助创建和维护管理文档，包括标准运营程序，执行资源，指南和培训材料来支持出版流程。- **持续学习与发展**:保持有关行业趋势，最佳实践和相关的监管变化的信息。**资格，技能和经验** **教育最低要求：** - 高中学历或相等 （没有相对体验）**必需技能和经历：** - **人际技巧**:能够与他人合作并有效地沟通，无论是口头还是书面上：**技术能力**: 计算机程序知识，如 MS Word 和 Ad
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Job Description
**Position Title**
Associate Specialist, Global Submissions Publishing (GSP)
**Department**
Regulatory Planning and Publishing (RPP)
**Brief Description of Position**
Global Submissions Publishing, comprised of Regulatory Content Management and Submission Publishing, works closely with various stakeholders to ensure the timely completion of submission components and assemblies that adhere to global regulatory health authority policies and technical requirements as well as internal guidelines for electronic/hardcopy submissions.
**Submission Publishing** is responsible for assembling, linking, and delivering high-quality regulatory dossiers to health authorities, facilitating expeditious agency reviews that align with industry cycle times.
_Key Responsibilities of Submission Publishing:_
- **Submission Activities Support**: Execute the comprehensive publishing process, including quality control, verification, finalization, delivery of submission dossiers, and archiving to ensure compliance with industry standards and regulatory requirements.
- **Timely Completion of Submission Assemblies**: Ensure that all dossiers are finalized and submitted by the specified deadlines to uphold project schedules and achieve organizational objectives.
_Shared Responsibilities:_
- **Collaboration**: Collaborate with authors, contributors, and stakeholders to ensure high-quality outputs, enhance project outcomes and drive collective success.
- **Testing and Implementation of New Tools and Processes**: Engage in the testing and evaluation of new publishing tools and processes. Provide feedback and suggestions for improvements to enhance efficiency and effectiveness.
- **Development of Administrative Documentation**: Assist in the creation and maintenance of administrative documentation, including standard operating procedures, execution resources, guidelines, and training materials to support publishing processes.
- **Continuous Learning and Development**: Stay informed about industry trends, best practices, and regulatory changes related to publishing sciences.
**Qualifications, Skills & Experience**
**Education Minimum Requirement:**
- High School Diploma or equivalent (no relative experience)
**Required Skills and Experience:**
- **Interpersonal Skills**: Ability to work collaboratively with others and communicate effectively, both verbally and in writing.
- **Technical Proficiency**: Knowledge of computer programs such as MS Word and Adobe Acrobat Professional, with a demonstrated ability to learn new systems and technologies quickly.
- **Time Management**: Strong organizational skills to manage multiple time-sensitive assignments efficiently.
- **Adaptability**: Flexibility to adapt to a changing environment, staying current with new and updated processes and procedures.
- **Cultural Sensitivity**: Good interpersonal skills and experience in handling diverse cultures, with effective communication skills in English and regional languages.
- **Quality and Compliance Awareness**: Demonstrates an understanding of the business value of quality and compliance, recognizing the implications and risks of non-compliance. Adjusts behaviors to drive high-quality deliverables.
- **Problem Solving and Critical Thinkings**: Ability to independently identify and resolve problems that arise within job responsibilities, ensuring a proactive approach to challenges.
**Additional location(s) Compensation Information:**
**Required Skills:**
Adverse Event Report, Adverse Event Report, Audits Compliance, Change Management, Competency Management, Conceptual Thinking, Continuous Development, Data Quality Assurance, Documentation Maintenance, Documentation Preparation, Document Control Systems, Document Management, Efficiency Improvements, Electronic Common Technical Document (eCTD), Employee Training Programs, Lateral Thinking, Microsoft Word, Multitasking, Performance Improvements, Policy Implementation, Process Improvements, Product Delivery, Records Retention Management, Regulatory Applications, Regulatory Communications {+ 7 more}
**Preferred Skills:**
Current Employees apply [HERE](https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply [HERE](https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
**VISA Sponsorship:**
**Travel Requirements:**
**Flexible Work Arrangements:**
Remote
**Shift:**
**Valid Driving License:**
**Hazardous Material(s):**
**Job Posting End Date:**
10/22/2026
***A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.**