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Cardinal Health logo
Cardinal Health

Cardinal Health is an award-winning Fortune 500 healthcare company specializing in the distribution of medical products and pharmaceuticals. The company serves

Scientist I

Location

United States

Posted

16 days ago

Salary

$32 - $40 / hour

Seniority

Mid Level

Job Description

Scientist I

Cardinal Health

Role Description The Scientist I in CMC supports regulatory activities for pre-approval, post-approval changes, and lifecycle management across client Rx and non-Rx products. Working as a consultant, this role assists in the preparation, review, and coordination of regulatory documentation, while ensuring alignment with applicable regulatory requirements and client expectations. The individual will collaborate closely with cross-functional teams and contribute to the timely delivery of high-quality regulatory submission content. - Support the development, authoring, and compilation of regulatory documentation related to post-approval changes and lifecycle management activities. - Assist as an authoring strategist by organizing and maintaining submission-ready documents in accordance with regional regulatory requirements. - Collaborate with cross-functional teams (e.g., CMC, Quality) to gather and verify required information for regulatory submissions. - Ensure documentation consistency, accuracy, and compliance with internal standards and client expectations. - Track and manage document timelines and deliverables to support regulatory milestones. - Maintain clear and proactive communication with client stakeholders while operating in a contractor capacity. - Ensures an established level of billable hours per fiscal year. Qualifications - 0-2 years of experience, open to new graduates. - Bachelor's degree in related field, or equivalent work experience, preferred. - Proactive, self-motivated, and able to work independently in a client-facing role. - Strong attention to detail and organizational skills. - Effective written and verbal communication skills. - Ability to manage multiple tasks and meet deadlines in a dynamic environment. - Basic proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). - Working knowledge of Adobe Acrobat for document editing, formatting, and publishing. - Team-oriented mindset with the ability to collaborate across functions. Requirements - Applies basic concepts, principles and technical capabilities to perform routine tasks with attention to detail. - Works on projects of limited scope and complexity. - Follows established procedures to resolve readily identifiable technical problems. - Works under direct supervision and executes detailed instructions. - Develops competence by performing structured work assignments. - Support client projects as a consultant. - Ability to work remotely from home office. - Requires adaptability and responsiveness to changing project priorities. Benefits - Medical, dental and vision coverage. - Paid time off plan. - Health savings account (HSA). - 401k savings plan. - Access to wages before pay day with myFlexPay. - Flexible spending accounts (FSAs). - Short- and long-term disability coverage. - Work-Life resources. - Paid parental leave. - Healthy lifestyle programs.

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