Regulatory Affairs Associate Specialist - Ft Worth TX

McKesson Corporation is a Fortune 8 company and is one of the largest providers of healthcare supply chain management solutions, retail pharmacy, medical & pharmaceutical supplies, healthcare technology, community oncology and specialty care in the United States with revenues of $231 billion in 2020. The company was founded in 1833 by John McKesson and Charles Olcott in New York with a focus on importing and wholesaling pharmaceutical products. United by our ICARE shared principles, McKesson's 80,000 employees work together every day to make better care possible around the globe - one product, one partner, one patient at a time.

This role is located at the Fort Worth Office

Position Description

We are seeking a Regulatory Affairs Associate Specialist. As a member of the Central Support Team, this role's primary responsibility is to support McKesson's Controlled Substance Monitoring Program (CSMP). The duties for this position include, but are not limited to, providing administrative support to the Regulatory Affairs Department; supporting the Regulatory Affairs Team Lead in the processing of regulatory documentation; conducting initial customer due diligence; and using tools, reports, and data in accordance with CSMP policies and procedures. This position supports projects ranging in size, complexity, effort, and that impacts the CSMP. This will require collaboration with internal partners, regulatory affairs team members and customers.

Key Responsibilities

• Organize and coordinate incoming regulatory requests, which includes monitoring and ensuring completeness of documentation and creating and maintaining regulatory due diligence files in accordance with CSMP policies and procedures;
• Participate in due diligence reviews that may include conducting state license and DEA registration checks, Office of Inspector General database checks, open-source checks, and use of external data (i.e. ARCOS);
• Drafting, detailed due diligence reports or other related documents;
• Frequently interact with Regulatory Affairs team members to support CSMP processes;
• Liaison with customers or McKesson Sales personnel on behalf of the Regulatory Affairs Department to secure additional information as needed.

Minimum Requirements

Minimum 0-2 years of relevant experience.

Critical Skills

• Understanding of project management and process development
• Excellent ability to prioritize and manager multiple, concurrent projects, priorities, tasks effectively
• Ability to succeed in a high-stress environment; ability to work under pressure and manage multiple deadlines in an efficient and timely manner
• Excellent verbal and written communication, collaboration, and influencing skills
• Detail oriented, strong writing and analytic skills

Additional Knowledge & Skills

• Working knowledge of Federal and State government laws and regulations related to controlled substance pharmaceuticals preferred
• Intermediate to advanced MS Office skills (Word, Outlook, Excel & PowerPoint)
• Ability to adapt to changing environment/technology, results oriented
• Must be a team player who can develop strong working relationships
• Proactive problem-solving approach with strong interpersonal skills
• solid business acumen and integrity

Education

HS Diploma or equivalent required, Bachelor's Degree preferred

Physical Requirements

General office demands

Must be authorized to work in the US. Sponsorship is not available for this position

We take pride in our culture of connection and believe in a workplace where everyone can be their full, authentic self. We welcome and encourage veterans, individuals with disabilities and others with diverse perspectives to join our growing team. Your unique perspective and experience are valuable assets that can translate into a rewarding career path with us. Apply to join our team and help shape the future of healthcare!

McKesson is an Equal Opportunity/Affirmative Action employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.Qualified applicants will not be disqualified from consideration for employment based upon criminal history.

McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to McKessonTalentAcquisition@mckesson.com . Resumes or CVs submitted to this email box will not be accepted.

Current employees must apply through the internal career site.

Join us at McKesson!