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 an Associate Director, Global Submission Management, 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 an Associate Director, Global Submission Management, you will be responsible for the daily management and oversight of local/regional staff, as well as the personal and professional development of Global Submission Managers (GSMs). The Associate Director will be responsible for ensuring alignment with the core competencies of the GSM role, and for measurement of performance against functional goals and expectations. The Associate Director retains flexibility to participate in projects as a GSM in addition to assuming leadership responsibilities for the GSMs at their site or region. The Global Submission Manager (GSM) works effectively with global/regional cross functional teams to plan, monitor and deliver compliant regulatory submissions. The GSM introduces flexibility within and across therapeutic areas (development and marketed products) to provide broad regulatory submission support to ensure all submission and business deliverables are met in a timely manner. In collaboration with key members from global and local regulatory affairs, the GSM will compile and execute submission strategy plans for new marketing authorisations as well as submission strategies for the maintenance of existing drug licenses.
The GSM promotes a global e-working environment in collaboration with Submission and Information Management personnel (SIM), this includes regulatory systems, tools and e-submission expertise. The GSM strives to drive efficient, standardized best practices for regulatory submission documentation necessary for applications via the end-end submission model to approval, through product launch and beyond. The GSM continually monitors, interprets and validates evolving agency submission standards/policies and assesses the potential impact to business process to ensure compliance and efficiency in the delivery of submissions. The GSM contributes to solutions with respect to regulatory submission issues by ensuring potential risks are identified and mitigation plans are put in place. This position also contributes to continual process improvement and change management procedures and may coach other members of the GSM team.
The above will be carried out according to regulatory guidelines as well as PRA relevant SOPs. This position will also ensure that PRA is aware and responsive to external guidelines, regulations, changes in the marketplace and other information relating to global regulatory submission management.
The GSM will act in a manner befitting PRA core values.
What do you need to have?
Education: Bachelor’s degree (or significant proven experience in a pharmaceutical environment)
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.