Senior Coordinator, Regulatory Submissions Operations in Harrisburg, Pennsylvania

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

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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.