Sr Regulatory Publishing Specialist at PRA Health Sciences in Remote

Description

We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA.

Who are we?

We Are PRA.

We are 17,000+ 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 help get life-saving drugs into the hands of those who need them most.

Qualifications

What you need to have: Bachelor’s degree in relevant field of study or equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated. 5 years of relevant experience.In-depth knowledge of the drug development process In-depth knowledge of regulations governing pharmaceutical document submissionsExcellent skills in use of electronic submission publishing tools and/or document managemet systemsAdvanced knowledge of review and approval processes of applicable regulatory agenciesStrong understanding of document management systems and conceptsSkilled in interpretation and utilization of applicable technologiesExcellent written and oral communication skillsAbility to introduce new systems and procedures based on interpretation and application of regulatory agency guidance documents and statutesStrong ability to plan, organize and deliver multiple and/or complex projects Ability to lead and motivate team members, without direct line management responsibility in matrix environmentExcellent ability to understand complex issues and propose creative and achievable solutions To qualify, applicants must be legally authorized to work in the United States or Canada, and should not require, now or in the future, sponsorship for employment visa status.PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

Responsibilities

What You Will Be Doing? The Senior Regulatory Publishing Specialist will be accountable for providing publishing and submission support in the development of global regulatory submissions.

• Acts as primary publisher of all worldwide regulatorysubmission types,e.g., electronic,paper accordingto SOPs andwithin establishedtimeframes requiring no technical direction.
• Sets submission strategy for complex submissions.
• 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 reportor 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 thatmay delay/impact the submission and presents risk mitigation for publishing
• strategy.
• May obtain certificates and coordination of relevant legalization of documents.