上海招聘

Principal Duties and Responsibilities:

1. Writes, edits, reviews, and formats documents that conform to domestic and/or international regulatory submissions (IDEs, PMAs, 510(k), Clinical Evaluation Reports, Technical Files, Design Dossiers, Instructions for Use, Labeling) and internal document standards, while meeting project timelines.
2. Coordinates content development with multi-discipline subject matter experts, both internal and external to NAMSA.
3. Provides medical writing, editorial and peer-review support for publications, abstracts, posters, white papers and other promotional material.
4. Responsible for ensuring that assigned documents undergo a quality check before approval, and that documents are routed correctly in the document QC process.
5. Attends meetings about document(s) in development and provides management, team and reviewers with document status reports as needed.
6. Supports communication strategy development.
7. Collaborates with other writers to ensure continuous improvements in writing style, harmonization of terminology, and team initiatives.

Qualifications and Skills：

1. Bachelor’s degree or equivalent experience in life sciences or a related field, with a minimum of 5 years of medical writing experience in the medical device industry.
2. Advanced degree in Writing/English or completion of a technical writing program in addition to 4-year college degree, is a plus.
3. Fluency in English and local language, if different, required.
4. Strong computer skills, project management skills, problem solving skills and a high attention to detail.
5. Strong communication skills, both written and oral.
6. Comfortable working in a regulated industry that demands tracking changes to regulatory requirements.
7. Exceptional organizational skills.

        NAMSA建立于1967年，至今已经有50余年的历史，是全球医疗器械安全性和有效性研究领域中公认的先驱。早在美国FDA 1976年对医疗器械建立比较完整的监管法规之前，就在美国市场中为科学家对医疗器械安全性和有效性研究提供各种实验室测室测试研究服务。

        如今NAMSA为医疗器械厂商提供全程产品开发研究、风险管理、和质量管理的实验室数据测试、临床研究计划实施和 法规的咨询服务。服务的领域涉及几乎所有医疗器械产品，例如心血管、骨科、眼科、牙科、诊断试剂等等。

        在全球医疗器械安全研究领域，NAMSA始终处于学术的最前沿。很多研究成果被全球标准组织采纳，作为各国医疗器械安全监管的基础。

NAMSA is a medical research organization providing expert regulatory, laboratory, clinical, and compliance services to medical device and healthcare product manufacturers. At every stage of the product development process, we provide strategic guidance and tactical support to help clients commercialize medical products in the major markets of the world.

We serve as your trusted partner, using our insight to identify strategies for saving time, while never compromising quality. We know that compromised quality can quickly take your product right back to the starting line. That’s why it’s so important to have a smart strategy from the outset—and why we put it at the forefront of every project.

The path to regulatory approval can be long and complex. We provide a reliable way to get there.