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.
Working fully embedded within one of our pharmaceutical clients, with the support of PRA right behind you, you’ll be at the heart of our client’s innovation.
At PRA we are heavily focused on career development. We have lots going on in the Medical Writing team; this role will grow, and the selected applicant will be fulfilled. The team is constantly reviewing the needs of the team - so, if you are a motivated and ambitious Medical Writer, the sky is the limit.
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:
* Researching, writing, and editing clinical documents by applying functional expertise and clinical drug development knowledge.
* Leading medical writing activities within a designated therapeutic or functional area 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.
* You will need substantial experience writing for pharma or biotechnology.
* Experience as lead writer for key documents included in major China and/or international regulatory submissions required.
* Experience managing writing activities for a major China or international regulatory submission (project or people management) preferred