监管出版经理（拉美区）
Regulatory Publishing Manager (LATAM)
拉丁美洲监管发布经理
Syneos Health® 是一家领先的全集成生命科学服务组织，致力于加速客户成功。我们与药物开发和商业化全过程中的创新者合作，帮助他们应对复杂性、预见变化并加快进展。
我们的临床解决方案团队成员具备药物开发思维，运用多年的经验和专业知识，真正理解客户需求，并在我们打造的解决方案中代表这些需求。
无论您加入我们作为功能服务提供商合作伙伴还是全服务环境的一员，您都将与充满热情的问题解决者合作，作为一个团队进行创新，帮助我们的客户实现目标。我们敏捷且以交付为导向——为彼此、为客户，最重要的是，为那些需要帮助的人。
了解您的25,000名未来同事已经知道的内容：
为什么选择 Syneos Health
• 我们热衷于发展员工，通过职业发展和晋升；支持性的直线管理；技术和治疗领域培训；同行认可和全面奖励计划。
• 我们致力于建设一个包容的文化——您可以真实地做自己。这背后的核心是我们“驱动交付”的使命，体现了同事们每天到场并塑造能够显著影响他人生活的解决方案的热情。
• 我们不断打造我们所有人都希望工作的公司，以及客户希望与之合作的公司。为什么？因为我们知道，当我们将来自世界各地的聪明才智汇聚在一起时，我们可以塑造医疗健康的未来，为客户带来影响，并定义患者进展的速度。
职位职责
监管发布高级经理负责电子提交的创建、汇编和发布，并高效及时地提交给全球卫生当局。该职位负责在组合层面领导发布活动，并负责维护和生命周期管理相互关联且依赖于多个同时提交的文件。可以领导跨项目的复杂提交工作。该职位需要与相关方和项目团队合作，确保内容按时发布，并推动项目团队达到格式标准和期望。该职位负责内容的准确性。
查看英文原文
Regulatory Publishing Manager (LATAM)Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:
Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
The Regulatory Publishing Senior Manager is responsible for the creation, assembly, and publishing of electronic submissions and the delivery to global health authorities in an efficient and timely manner. The role is accountable for leading publishing activities on a portfolio level and responsible for the maintenance and lifecycle management submissions that are inter-related and dependent on multiple concurrent submissions. Can lead complex submission work across programs. This role will work with stakeholders and project teams for the timely delivery of content to be published, as well as drive for project teams the standards and expectations of format. This role is responsible for the accuracy of published output to Vertex and industry standards and health authority requirements. The Regulatory Publishing Senior Manager will be responsible for leading process improvements for the accurate and quality driven execution of submissions
Key Duties and Responsibilities:
- Works independently within the publishing/content systems to create published output for submission
- Creates and assembles all components of defined submissions in required format as per health authority guidance
- Validates submissions through the application of acquired experience
- Manage portfolio views of upcoming submissions and publishing interdependencies
- Collaborates with submission managers and regulatory leads for submission preparation and timelines
- Liaises with functional source areas to ensure documents are compliant and submission ready
- Collaborates with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Originally posted on Himalayas