kansas | Sr. Regulatory Publishing Specialist in Winfield, KS

Sr. Regulatory Publishing Specialist

  • PRA Health Sciences
  • $33,530.00 - 49,070.00 / Year *
  • 2702 T P Hales Rd
  • Winfield, KS 67156
  • Full-Time
save job button



Do you want to watch drug development change, or do you want to be the one to shape it?

We're hoping you're here for the latter.

Who are we?

We Are PRA Health Sciences. We provide innovative drug development solutions across all phases and therapeutic areas. But innovation just for the sake of innovation isn't why we do it. Side by side with our clients, we strive to move drug discovery forward, to help them develop life-saving and life-improving drugs. We help change people's lives for the better every day. It's who we are. Innovating to help people is at the heart of our process, but it's even more than that. It's our privilege.

We are 15,000+ 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.

The Sr. Regulatory Publishing Specialist 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 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 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.

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

Problems are differing but related. Solutions are not readily apparent. Undertakes analysis and investigation to identify and define problems. Anticipates future issues. Work is done independently, reviewed at critical points.

Adapts style and uses persuasion in delivering messages. Issues may be complex, audience

perspectives may be divergent, and information may be non-routine in nature. Audience may not be knowledgeable about the subject matter

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, risksand issues that may delay/impact the submission and presents risk mitigation for publishing strategy.? May obtain certificates and coordination of relevant legalization of documents.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 directionProblems are differing but related. Solutions are not readily apparent. Undertakes analysis and investigation to identify and define problems. Anticipates future issues. Work is done independently, reviewed at critical points.Adapts style and uses persuasion in delivering messages. Issues may be complex, audienceperspectives may be divergent, and information may be non-routine in nature. Audience may not be knowledgeable about the subject matter5 years of relevant experienceBachelor's degree in relevant field of study.PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.


* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.