PRA Health Sciences is an award winning CRO. We are proud to have won Pharma Times 'Clinical Research Company of the Year' in 2017 for the fourth consecutive year. We aren’t winning these awards by chance; PRA is being recognised industry-wide for our dedication to the future of clinical development. Most importantly for you, at PRA we recognise that our success is down to our people. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA.
An experienced Principal level medical writer is required to support our clients in China. The candidate will be responsible for writing and editing a wide range of regulatory clinical documents including clinical study reports, protocols and regulatory submissions. This position offers excellent development potential and the opportunity to join our highly successful global medical writing team.
In this role, you will act as a lead medical writer on key programs, providing scientific and medical writing consultancy to one of our top client and internal colleagues. Other responsibilities will include:
- Acts as a lead medical writer on numerous programs and individual studies at a moderate to complex level.
- Provides scientific and medical writing consultancy to clients and internal colleagues at a complex level.
- Leads project teams in drafting reports, medical writing, and coordination of regulatory submissions and data analysis.
- Manages all aspects of the medical writing function, potentially including line management.
- Serves as an active mentor to all levels of medical writing personnel.
- Develops and implements training for medical writers.
- Oversees operational activities of other medical writers as the project team leader.
- Conducts in-service training for clinical research associates, other clinical functions, and clients in areas of therapeutic expertise.
- Provides bid estimates for medical writing work for potential projects and attends bid defense meetings when requested.
- Provides project teams with expertise on regulatory requirements governing documents for regulatory submission.
A team worker with the ability to influence in order to achieve objectives. You will have excellent organisational skills, flexibility and attention to detail along with a mind-set towards adherence to timelines.
You will be a highly motivated and dynamic medical writing professional with strong knowledge of the pharmaceutical industry, a positive attitude and ambition to make things happen.
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have
- 8 years of experience in science or medical-related writing.
- Experience in medical writing to support Regulatory submission documents in China is required.
- Advanced degree in a science or health-related field is preferred.
- Advanced understanding of regulatory guidance in China is required.
- Medical writers must speak both Chinese and English.