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Senior Specialist, Regulatory Submission Management

2 months ago

Oklahoma City, Oklahoma, United States Cardinal Health Full time

What Regulatory Submission Management contributes to Cardinal Health

The Regulatory Submission Management team utilizes advanced technology and expertise to format, edit, and compile both paper and electronic documents pertaining to regulatory submissions in the pharmaceutical sector throughout various stages of drug development and the product lifecycle. This role is responsible for application submission and renewal services related to state licensing, preparing specialized electronic files for drug registrations, listings, and self-identification, as well as overseeing and maintaining document management systems for version control.

Location

Remote (nationwide)

Key Responsibilities

  • Evaluate and negotiate project timelines
  • Manage client documentation utilized in submissions
  • Process client documents using publishing software
  • Identify issues and communicate effectively with internal and external partners

Qualifications

  • Proficiency in Microsoft Office (Word, etc.) is essential for success in this position
  • Experience with Adobe (formatting, editing) is a critical requirement
  • Seeking candidates with a keen attention to detail
  • Looking for individuals with strong communication skills (both written and verbal), who take pride in delivering high-quality work and are proactive in seeking clarification
  • Ideally, candidates should have 2+ years of professional experience (background in publishing, editing, or regulatory affairs is advantageous but not mandatory)

Expectations for this Role

  • Effectively applies knowledge of job and company policies to complete a variety of assignments
  • Utilizes advanced skills to independently resolve complex issues
  • May adjust processes to address challenges
  • Works autonomously within established procedures; may receive general guidance on new tasks
  • May provide guidance or technical support to less experienced team members

Compensation and Benefits

Cardinal Health offers a comprehensive benefits package to support employee health and well-being, including:

  • Medical, dental, and vision coverage
  • Paid time off
  • Health savings account (HSA)
  • 401k savings plan
  • Access to wages before payday with myFlexPay
  • Flexible spending accounts (FSAs)
  • Short- and long-term disability coverage
  • Work-life resources
  • Paid parental leave
  • Healthy lifestyle programs

Inclusivity Statement

Cardinal Health is committed to fostering an inclusive workplace that values diverse perspectives and experiences. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves every day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status, or any other status protected by federal, state, or local law.