An experienced 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.
At PRA, we don’t make our 15000+ people great. It’s the other way around. As we have grown to a top-5 CRO, we have maintained the feel of a small company, dedicated to collaboration and passion for what we do.
We always have a desire to keep seeking new and better ways to operate. We don’t settle for the same old ways. Our passion for improving patient lives worldwide permeates all that we do.
If you're ready to be a part of something inspiring join us and Discover Your PRA.
In this role, you will act as a lead medical writer on key programs, providing scientific and medical writing consultancy to our clients and internal colleagues. Other responsibilities will include:
* Leading project teams in drafting reports, medical writing, and coordination of regulatory submissions and data analysis.
* Researching, writing, and editing clinical documents by applying functional expertise and clinical drug development knowledge.
* Leading medical writing activities for key response documents and regulatory submissions.
* Leading the writing strategy providing expertise including organization, content, timelines, and resource requirements.
* Serving as lead writer for important regulatory response documents and key components of regulatory submissions.
* Providing leadership on functional teams that address requirements or issues related to document preparation and production.
* Serving as an expert in medical writing and performing work independently with minimal supervision.
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:
* Bachelor’s degree in science, health profession, or journalism (advanced degree in a science or health-related field is preferred).
* You will need substantial experience writing for CROs/pharma or biotechnology.
* Experience as lead writer for key documents included in major China and/or international regulatory submissions preferred.
* Experience managing writing activities for a major China or international regulatory submission (project or people management) preferred.
* Medical writers must speak both Chinese and English.