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We Are PRA.
We are 16,000+ employees strong, operating in more than 90 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 leader that isn’t afraid to delegate, but also isn’t afraid to get your hands dirty. You look for new and innovative ways to problem solve. You are the ultimate planner and coordinator and are an excellent communicator. You never settle for what is, but are always pushing clinical development forward to what it could be. You motivate others to do the same. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.
The Senior Regulatory Publishing Specialist will be accountable for providing publishing and submission support in the development of global regulatory submissions.
What You Will Be Doing
- Participates in submission/project and provides publishing solutions.
- Directly communicates project specifics to internal and external clients.
- Organizes, compiles and publishes documents and submissions for regulatory deliverables.
- Acts as primary publisher of all worldwide regulatory submission types, e.g., electronic, paper according to SOPs and within established timeframes requiring no technical direction.
- Sets submission strategy for submissions complex solutions.
- Provides oversight to strategic planning and publishing timeframes required for a specific submission.
- Promotes submission publishing efficiencies by promoting re-use of documents, adopting global dossier principles and standardizing processes to enable simultaneous compilation and publication of submissions.
- Collaborates with other submission publishers to assure standard practices and quality submission outcomes
- Participates in multi-discipline work streams as publishing subject matter expert.
- Provides report- or document-level publishing as needed.
- Educates document authors on technical submission formats and lifecycle management and regional submission requirements.
- Acts as submission coordinator on project teams for functional or cross functional submissions of high complexity that do not have a leader assigned
- Performs quality control review of submission component documents to client and regulatory agency specifications.
- Proactively identifies and escalates publishing issues as necessary.
- Mentors less experienced team members.
- Leads discussions or work stream to develop process efficiencies.
- Actively participates in global publishing meetings to ensure publishing processes are consistent among regions.
- Performs quality control review of published and printed documents to client and regulatory agency specifications prior to client delivery.
- Proactively escalates publishing concerns, risks and issues that may delay/impact the submission and presents risk mitigation for publishing strategy.
- May obtain certificates and coordination of relevant legalization of documents.
What do you need to have?
Typical Minimum Education/Experience:
- Bachelor’s degree in relevant field of study preferred or equivalent work experience
- Extensive background in global publishing, including eCTD, NeeS and paper submissions
Knowledge, Skills and Abilities:
- In-depth knowledge of regulations governing pharmaceutical document submissions
- Excellent skills in use of electronic submission publishing tools and/or document management systems
- Excellent communication, interpersonal and time management skills
- Ability to work autonomously under limited direction