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Associate Regulatory Publishing Specialist

Lenexa, KS

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Assists in ensuring submissions of low complexity are published according to standard operating procedures (SOPs) within established timeframes. Performs quality control review of submission documents to client and regulatory agency specifications. Supports document-level publishing as needed. Proactively identifies and escalates publishing issues as necessary. Actively participates in local and global publishing meetings to ensure publishing processes are consistent among regions. Helps perform quality control review of published and printed documents to client and regulatory agency specifications prior to client delivery. Responsibilities u2022 Acts as a lead representative on projects for issues related to preparation of electronic and paper submissions. u2022 Propose solutions for technical publishing issues. u2022 Provides advanced word processing support, including troubleshooting for technical document authors. u2022 Takes a lead role in reviewing documents for legibility, format, completeness, and accuracy according to electronic submission standards. u2022 Performs quality control review of published and printed documents to client and regulatory agency specifications. Qualifications Basic knowledge about the pharmaceutical industry Good communication, interpersonal and time management skills Ability to follow directions and learn quickly Develops working knowledge ofu00a0publishing systems and processes. Exhibits basic proficiency in using pertinent computer software (MS Word, Adobe Acrobat). Understands current regulatory guidance information, particularly related to publishing electronic submissions Bacheloru2019s degree is preferredu00a0 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. PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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