Do you want to watch clinical development change, or do you want to be the one to shape it?
Because we’re hoping you’re here for the latter.
Who are we?
We Are PRA.
We are 13,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.
Who are you?
You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Publishing and Submission Support Specialist, you want to change the future. You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.
Still here? Good. Because if this is you, we’d really like to meet you.
What will you be doing?
As a Publishing and Submission Support Specialist, you will assume primary responsibility for the compilation and publishing of Wave 1-3 global regulatory submission types and submission support activities in accordance with Global Regulatory Affairs objectives. The PSS will contribute to publishing strategies to ensure that compliant submissions are delivered according to the worldwide regulatory submission plan and regional/country requirements. Promoting a global e-working environment and driving efficient, standardized best practices for regulatory submission document management, the PSS will participate in project teams and/or partner with document authors to communicate submission processes, internal and external submission requirements and document standards. Partnering with the Global Submission Manager, the PSS will provide input to the submission strategy to introduce efficiencies by promoting re-use of documents, adopting global dossier principles and standardizing processes to enable simultaneous compilation and publication of submissions. The PSS will also provide administrative support for submissions, e.g. obtaining certificates and key submission documents (Certificate of Pharmaceutical Product (CPP), Certificate of Good Manufacturing Practice (GMP), Letter of Authorisation), managing legalization, notarization and apostil and also ensure document submission readiness and final archiving of submissions.
What do you need to have?
Education: Bachelor’s degree is required.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.