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 Senior Manager, Global Labeling, 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 Senior Manager, Global Labeling, you will function as the regulatory expert for labeling on the global Regulatory Affairs (RA) Subteam to ensure that regulatory labeling requirements are met for new product submissions. Additionally, he/she is responsible for the development and maintenance of Company Core Data Sheets (CCDS) across multiple therapeutic areas in line with international standards and guidelines. The Manager will guide the development of submission labeling for new compounds through the RA subteam, including multiple key markets (US, EU, others in line with global Regulatory Strategy). Prepare the CCDS for assigned compounds during the development/submission cycle, and maintain through product lifecycle. Oversee label content on a global basis to ensure that messages consistently meet strategic and business objectives, with appropriate supporting data. Manages communication plans for affiliates regarding CCDS changes and required actions based on Global Labeling Oversight Committee (GLOC) decisions.
What do you need to have?
BS/BA degree with 5 years in Regulatory or related area, 3 years experience in labeling (or similar skill set) within the pharmaceutical industry.
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.