At PRA, we don't make our 16000+ 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. Put simply, we care.
As a Senior Regulatory Publishing Specialist, you will work within one of PRA's key client partnerships with responsibility for publishing and submission support in the development of global regulatory submissions to Health Authorities.
Key tasks will include:
· Acting as the primary publisher for various regulatory submissions (including NeES, eCTD and paper formats), setting the strategy for the submission
· Planning and publishing of the lifecycle submissions portfolio, with accountability of monitoring the submissions forecast and managing timelines and quality
· Liaising with other stakeholders, including Regulatory Affairs, Submission Managers etc to ensure submission requirements and timelines are agreed upon
· Analyse regulatory guidelines and regulatory documentation practices to ensure compliance
· May also serve as Subject Matter Expert for various publishing tools or dossier types
Focused primarily on the lifecycle submissions portfolio, you may also work on departmental initiatives, process improvement, validation testing or highly-complex submissions.
Tenacious, collaborative and keen to learn new ways of working.
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:
· Proficiency in regulatory publishing across Europe or globally
· The ability to adapt to new ways of working and learn new processes
· Experience with eCTDXpress and/or Liquent IP preferred but not essential
· A strong understanding of regulatory requirements and submission processes
· Fluency in English
· Bachelor's degree in a relevant field of study
Your health, your family, your career, your money - the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace...... click apply for full job details
Apply for Job