Senior Coordinator, Regulatory Submissions Operations

4 weeks ago


Somerville, United States Cardinal Health Full time
What Regulatory Submissions Operations contributes to Cardinal Health
Regulatory Submissions Operations uses specialized technology and knowledge to format, edit and compile paper and electronic documents related to the pharmaceutical industry regulatory submissions throughout each phase of drug development and though the drug product life cycle. This position provides application submission and renewal services for state licensing activities, prepares specialized electronic files for drug registrations, drug listings and self-identification, and oversees and maintains document management databases for version and revision control.

Location - Remote (nationwide)

Responsibilities
  • Assess and negotiate timelines
  • Manage client documents used in submissions
  • Process client documents within publishing software
  • Identify concerns and communicate with upstream and downstream partners
Qualifications
  • Experience working with Microsoft Office (Word, etc) necessary for success in this role
  • Experience using Adobe (formatting, editing) a must have
  • Targeting individuals with a high level of attention to detail
  • Targeting individuals with strong communication skills (email, verbal), who take pride in producing high quality work, and aren't afraid to ask questions
  • Ideally targeting 2+ years of professional experience (background in publishing, editing, or regulatory a plus but not required)
What is expected of you and others at this level
  • Effectively applies knowledge of job and company policies and procedures to complete a variety of assignments
  • Applies advanced skills to resolve complex problems independently
  • May modify process to resolve situations
  • Works independently within established procedures; may receive general guidance on new assignments
  • May provide general guidance or technical assistance to less experienced team members
#LI-LP

#LI-remote

Anticipated Pay Range $25.20 per hour - $33.10 per hour

Bonus Eligible - No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
  • 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


Application window anticipated to close: 08/24/2024 * if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each 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.

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