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Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by diversity and inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health equity on a global scale. Join us to start Caring. Connecting. Growing together.

Optum is seeking a seeking a detail-oriented and highly organized individual to join our team for Licensure Support within the pharmaceutical and life sciences sector. This role is for a new service line within the Optum network and will work closely with cross-functional teams to facilitate the timely and accurate submission of licensure applications and maintain ongoing compliance throughout the licensure process.

You’ll enjoy the flexibility to telecommute* from anywhere within the U.S. as you take on some tough challenges.

Primary Responsibilities:

• Coordinate and manage the preparation, submission, and tracking of licensure applications, ensuring completeness, accuracy, and timeliness

• Oversee and manage the preparation and submission of regulatory documentation for any product labeling requirements

• Support team of regulatory professionals, both domestic and global, facilitating regulatory adherence, maintaining documentation, and meeting any authorization renewal requirements

• Ensure adherence to all applicable regulatory requirements for license and labels, including FDA, EMA, Wholesale Distribution Authorization (WDA), and other relevant authorities

• Support design and implementation of regulatory strategies for a new service line; ensure compliance with local and international regulations, including FDA, EMA, and other relevant regulatory agencies

• Provide guidance and support to project teams regarding regulatory requirements and potential risks and mitigation strategies

• Maintain an organized and up-to-date repository of all licensure-related documentation, including licenses, permits, certificates, and other relevant records

• Stay informed about changes in regulatory requirements and guidelines related to licensure support and ensure timely implementation of any necessary updates or modifications

• Identify potential risks and develop strategies to mitigate them, ensuring that regulatory activities are conducted in a manner that minimizes regulatory and compliance risks

• Proactively identify opportunities for process optimization and efficiency enhancements within the regulatory function, implementing appropriate measures to drive continuous improvement

You’ll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.

Required Qualifications:

• High School Diploma/GED (or higher)

• 2+ years of experience in licensure support independently submitting applications (or bachelor’s equivalent) within the pharmacy, pharmaceutical or wholesaler industry

• 2+ years of experience with FDA regulations, EMA guidelines, state requirements and other relevant regulatory requirements applicable to pharmaceutical manufacturing, distribution, and sales

Preferred Qualifications:

• Demonstrated intermediate-expert level of knowledge or 2-5 years of experience in health care policies, procedures, and documentation standards

• Demonstrated intermediate-expert level of knowledge or 2-5 years of experience in developing licensure strategies

• Demonstrated intermediate-expert level of knowledge or 2-5 years of experience in helping organizations apply for and procure licenses such as the Wholesale Distribution Authorization (WDA)

Soft Skills:

• Excellent organizational skills with the ability to manage multiple tasks and prioritize effectively

• Attention to detail and accuracy in documentation and record-keeping

• Strong communication and interpersonal skills to effectively collaborate with cross-functional teams and external stakeholders

• Ability to work independently and proactively while taking ownership of regulatory support activities

*All Telecommuters will be required to adhere to UnitedHealth Group’s Telecommuter Policy.

California, Colorado, Nevada, Connecticut, New York, New Jersey, Rhode Island, Hawaii, Washington, or Washington D.C Residents Only : The salary range for California, Colorado, Nevada, Connecticut, New York, New Jersey, Rhode Island, Hawaii, Washington, or Washington D.C residents is $88,000 to $173,200 per year. Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. UnitedHealth Group complies with all minimum wage laws as applicable. In addition to your salary, UnitedHealth Group offers benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with UnitedHealth Group, you’ll find a far-reaching choice of benefits and incentives.

Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

Application Deadline: This will be posted for a minimum of 2 business days or until a sufficient candidate pool has been collected. Job posting may come down early due to volume of applicants.

At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone–of every race, gender, sexuality, age, location and income–deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes — an enterprise priority reflected in our mission.

Diversity creates a healthier atmosphere: UnitedHealth Group is an Equal Employment Opportunity / Affirmative Action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law.

UnitedHealth Group is a drug - free workplace. Candidates are required to pass a drug test before beginning employment.

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