广州招聘

Since opening in 2007, PPD’s offices in China now include 20 different departments. The combined Beijing and Shanghai offices are now seven times the size they were two years ago and are continuing to grow. This is a great time to join PPD China. Currently PPD is recruiting for Senior Regulatory Affairs Specialist to join us.

If you’re a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our 775+ regulatory experts in 29 countries contribute the regulatory strategy and knowledge to help our clients navigate the ever-changing clinical trial regulatory environment—and help get life-changing therapies to patients faster. With our end-to-end solutions, we work to ensure regulatory compliance throughout the product life cycle, while helping to advance global product development.

Essential Functions and Other Job Information:

• Coordinates and manages client submission deliverables supporting regulatory compliance
• Assists in preparing electronic document outputs that meet requirements for regulatory publishing to include documents that work with sponsor and/or regulatory agency software programs meeting consistency and validation criteria
• Ensures that all final electronic deliverables meet current regulatory electronic document and submission requirements and guidances under general supervision of Manager
• Assists with developing and implementing project-specific processes for sponsors with unique electronic publishing/submission technology requirements and may act as the PPD liaison for electronic submissions with the sponsor
• Evaluates the publishing needs in relationship to the overall project timelines, quality and delivery
• Engages other project team members, functional units or publishing management as necessary to deliver final product and resolve/mitigate identified issues or barriers to delivery
• May act independently within a project team to evaluate and deliver publishing tasks
• Working knowledge of regulatory requirements and guidance for document management, and electronic publishing/submission

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification

• Ideally you will already have 2 or 3 years regulatory (or publishing) experience within a global context.

Knowledge, Skills and Abilities:

• Strong English language (written and oral) communication skills as well as local language where applicable
• Solid attention to detail and quality as well as strong editorial/proofreading skills
• Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments
• Solid computer skills including the use of Microsoft Word, Excel, Power Point, Adobe and Adobe plug-in tools (such as ISI ToolBox, or similar) EDMS (electronic document management system), RIMS (regulatory information management system), submission publishing tools; capable of learning new technologies
• Solid organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• Solid negotiation skills
• Capable of working independently and exercising independent judgment to assess sponsor regulatory electronic document publishing and submission needs and work with project team members to producing compliant deliverables
• Solid understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; good knowledge of ICH and other global regulatory guidelines; basic understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc.
• Solid understanding of medical terminology, statistical concepts, and guidelines
• Strong analytical, investigative and problem-solving skills
• Working knowledge of budgeting and forecasting

Our offer: PPD is a place where you can grow.

We want enthusiastic, energetic and creative regulatory staff to join us.

Our corporate and regulatory training and development programme, tailored to match your skills and needs, will put you on a track where you will:

• quickly be assigned to one or more ongoing regulatory projects
• have opportunity to positively contribute early in your time with PPD.
• get internal exposure to subject matter experts who can enhance your learning and development
• according to performance, have opportunity to work on wider range of projects and/or take specific responsibilities for specific elements of a project, including client interface
• be able to grow to reach the point where you are considered to lead/manage regulatory projects in PPD.

This is a full-time, permanent position.

Locations we are hiring in are:

?Office based Beijing

PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 44 countries and more than 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit ************.