Great 100% FULLY REMOTE Potential Job Opportunity Job Description: Prepare the content of labeling for revised labeling in structured product labeling (SPL) format using i4i software.
Submits SPL file using the FDA automated drug registration and listing system (eLIST) Prepare Summary of Labeling Changes section of Annual Report for Rx, Generics and OTC-NDA & Monograph products Support Regulatory Labeling team with other labeling activities as needed Top Skills Details: 4 years relevant pharmaceutical industry and regulatory experience, Bachelors degree preferred, applied knowledge of FDA labeling and SPL requirements, familiarity with XML concepts including structured product labels (SPLs) preferred.
Skills: Regulatory, annual report, labeling, labelling, pharmaceutical, consumer, FDA, Regulatory affairs, Regulatory Submissions, i4i, SPL Additional Skills & Qualifications: TECHNICAL COMPETENCIES: Strong technology skills and abilities, especially with Microsoft Office programs, and web-based programs.
Ability to critically and efficiently review detailed information to support a labeling revision.
Strong technical knowledge of drug listing and SPL, i4i software, and FDA automated drug registration and listing system (eLIST) PROFESSIONAL COMPETENCIES: Demonstrated ability in analytical reasoning and critical thinking skills Strong communication skills; both oral and written Strong interpersonal skills with the ability to influence others in a positive and effective manner Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies able to do so quickly without sacrificing attention to detail Experience Level: Intermediate Level About Actalent: Actalent connects passion with purpose.
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