Reg & Start-Up Lead (Shanghai)
This is a role that really sets the pace for each and every study. The goal is always to help bring new drugs to market, faster and more efficiently – making a real difference to the lives of patients. It is a role where self-motivation, a dynamic personality and the ability to work with, and lead a wide variety of highly-skilled professionals can let you develop the career you choose.
Award-winning and innovative, our projects have the size and reach to help you grow professionally. The role also offers a greater level of flexibility than many, with home-based or office working as options. There is also flexibility around working hours, as many projects require work across different international time zones. Yet at the same time, even if you are home-based, we make every effort to ensure a supportive team environment.
While projects vary, your typical responsibilities might include:
- Directing and managing the delivery of all required start-up, maintenance and regulatory activities for selected studies as determined by either the agreed algorithm or the Sponsor’s (customer’s) requirements
- This includes pre-award activities, oversight of the scope of work, budget and resources
- Developing and implementing the RSU Management Plan
- Ensuring collaboration across RSU, including communication with regions and countries
- Assisting with the creation and review of core scientific, technical and administrative documentation
- Contributing to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence
- Ensuring overall project efficiency and adherence to project timelines and financial goals
You will need to be comfortable negotiating, collaborating and communicating with a variety of colleagues and customers – including project and clinical leads. Ideally, you will also have an understanding of clinical research, project management and drug development. Good time management and attention to detail are also essential skills.
You should have:
- A Bachelor’s degree or equivalent in a life sciences, biopharma, nursing or related discipline
- A minimum of three years’ (ideally five) relevant experience
- Alternatively, you should have an equivalent combination of education, training and experience
If you want to make an impact in the global research market, where we are working to make a real difference in patient health, we ask you to apply now and join our team.
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Quintiles is a strong advocate of diversity and inclusion in the workplace. We believe that a work environment that embraces diversity will give us a competitive advantage in the global marketplace and enhance our success. We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees, builds a stronger team, and allows individual employees the opportunity to maximize their personal potential.
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