Senior Regulatory Affairs Consultant – Regulatory Lead
Parexel
Senior Compliance Associate
Maxor National Pharmacy Services, LLC
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $75,000 per year
Job Level
Senior
About the role
- Perform onsite pharmacy audits utilizing pharmacy compliance tools.
- Document and assess audit findings.
- Provide continual risk assessment in the area(s) of expertise.
- Escalate concerns as appropriate.
- Assist in the development, coordination, and execution of various initiatives.
- Research policies, laws, rules, & regulations, with assistance, and apply to appropriate setting.
- Investigate routine findings thoroughly.
- Review pharmacy practices and make recommendations to leadership on appropriate responses.
- Possess knowledge and experience to make decisions and judgments on sensitive, confidential issues.
- Seek ways to improve processes and propose changes effectively.
- Identify process/quality improvement opportunities that present risk to the organization.
- Educate team on regulatory requirements and best practices identified.
- Train entry-level associates.
- Perform other duties as required.
- Maintain regular attendance in accordance with established policies.
- Promptly report and escalate any allegations of impropriety appropriately.
- Comply with VytlOne Code of Conduct and Business Ethics policy and Compliance Program.
- Remain free from exclusion under the OIG and SAMS Medicare/Medicaid lists.
- Complete required training, as assigned, within the established timeframes.
Requirements
- High School Diploma or Equivalent
- Bachelor’s Degree preferred
- Active PTCB certification required
- Minimum of five (5) years of retail pharmacy experience required
- Two-five (2-5) years of Compliance experience required
- Compounding and hospital/health system experience preferred
- Knowledge of federal & state pharmacy requirements
- Ability to partner with diverse types of teams
- Excellent written and verbal communication skills
- Proficient in the use of various pharmacy and Microsoft Office software programs
- Knowledge of pharmacy practice and workflow
- Ability to work within deadlines and other stressful situations
- Ability to interpret policies and procedures and their applicability in the operation of the pharmacies
- Strong problem solving, organizational and decision-making skills
- Understanding of auditing best practices
- Must be able to accommodate frequent overnight travel up to 60%.
Benefits
- Comprehensive mental health and wellbeing resources
- Nationwide Blue Cross Blue Shield PPO with employee friendly plan design, including $850 individual annual medical deductible, $25 office visit copays, Low biweekly premiums
- Company paid basic life/AD&D, Short-term and Long-term disability insurance
- Rx, dental, vision, short-term disability, and FSA
- Employer-matched 401k Plan
- Industry leading PTO plan
- And MORE!
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
pharmacy compliance toolsaudit findings assessmentrisk assessmentprocess improvementregulatory requirementspharmacy practice knowledgecompoundinghospital experiencefederal pharmacy requirementsstate pharmacy requirements
Soft skills
communication skillsproblem solvingorganizational skillsdecision-making skillsability to work under stressteam collaborationtraining skillsprocess improvement mindsetconfidentiality judgmentinitiative execution
Certifications
PTCB certification
