SR Coordinator, Regulatory Submission Operations

Cardinal Health, Inc.; Northern (KY); Hybride; USD 37 000 - 48 000; Plein temps

Avantages offerts par ce poste

Medical, dental and vision coverage

Paid time off plan

401k savings plan

Paid parental leave

Health savings account (HSA)

Résumé du poste

Cardinal Health, Inc. is seeking a Senior Coordinator for Regulatory Submissions Operations to support regulatory affairs and product development through formatting, editing and submission of documents across drug development stages.

This remote role requires meticulous attention to detail, proficiency with Word, Excel and Adobe tools, plus strong communication and project management skills; experience with SOPs is a plus.

Qualifications

• Experience in advanced formatting of Microsoft Word documents is required.
• QA, QC, and SOP experience is a major plus.
• Experience in formatting and editing Adobe documents required.
• Familiarity with Excel required.
• Editorial and data analysis experience is a plus.
• Project management experience is a plus.
• Willingness to learn scientific principles.
• Attention to detail.
• Strong written and oral communication skills.

Responsabilités

• Format, edit and compile regulatory documents across the drug development life cycle.
• Provide submission support and maintain document management databases.
• 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.

Connaissances

Advanced Word formatting

QA/QC/SOP experience

Editorial and data analysis

Attention to detail

Strong communication skills

Willingness to learn scientific princ

Project management

Outils

Adobe Acrobat/Editing

Microsoft Word

Excel

Description du poste

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a global, integrated healthcare services and products company connecting patients, providers, payers, pharmacists and manufacturers for integrated care coordination and better patient management. Backed by 50+ years of experience, with more than 50,000 employees in nearly 60 countries, Cardinal Health ranks among the top 20 on the Fortune 500.

We boast tremendous opportunities to grow and apply technical skills to meet organizational needs, empowering talented team members who mentor and uplift others, led by leaders with afocus on employee development and well-being, dedicated training programs, and a collaborative atmosphere.

We currently have a career opening for a SR Coordinator Regulatory Submissions Operations

Location

Remote

What Regulatory Submissions Operations contributes to Cardinal Health

Regulatory provides regulatory affairs and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. This function applies subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting.

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 job family 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.

Responsibilities

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 through the drug product life cycle. This position provides application submission, prepares specialized electronic files for drug registrations, and oversees and maintains document management databases for version and revision control.

Additional responsibilities include:

• 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 in advanced formatting of Microsoft Word documents is required.
• QA, QC, and SOP experience is a major plus
• Experience in formatting and editing Adobe documents required.
• Familiarity with Excel required.
• Editorial and data analysis experience is a plus.
• Project management experience is a plus.
• Willingness to learn scientific principles.
• Attention to detail
• Strong written and oral communication skills.

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

Anticipated Pay Range $27.00 - $34.56 per hour USD

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

The hourly 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.

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.