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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacy auditing and compliance, with a strong understanding of REMS guidelines and FDA regulatory requirements. Capable of managing audit processes, training teams, and ensuring adherence to quality standards in the pharmaceutical and healthcare industries.
Highest-signal resume keywords
Pharmacy Auditing ExperienceREMS Guidelines KnowledgeFDA Regulatory ComplianceMicrosoft Office ProficiencyStrong Attention To Detail
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Pharmacy AuditingCompliance ReviewAudit DocumentationQuality ImprovementProject-Specific Audit PlansSOP ReviewsAudit TrainingDocument ReviewCorrective ActionsRisk Evaluation
Soft Skills
Effective CommunicationOrganizational SkillsProblem-Solving AbilitiesTime ManagementProfessionalism Under Pressure
Industry Keywords
HealthcarePharmaceutical IndustryREMS ProgramAudit FindingsRegulatory AuthoritiesQuality ComplianceStakeholder CommunicationContinuous Quality ImprovementEthical StandardsConfidentiality Protocols
About the role
Key responsibilities & impact- Provide effective communication to relevant stakeholders as the primary point of contact for REMS stakeholders in healthcare settings, pharmacies, and wholesalers/distributors
- Maintain thorough and accurate documentation of interactions
- Review project-specific audit plans, procedures, work instructions, questionnaires, and supporting documentation
- Complete timely reviews of assigned audit questionnaires
- Conduct document reviews for completeness, accuracy, and compliance with REMS program standards
- Follow up on audit documentation deficiencies and actions via phone or email
- Identify, evaluate, address, and communicate audit findings
- Complete audit review forms verifying adherence to REMS program requirements
- Assist with continuous quality improvement efforts
- Record and report audit results and corrective and preventive actions
- Collaborate with REMS Auditors to share best practices
- Complete SOP reviews and client-specific training
- Develop project-specific audit plans, procedures, and work instructions
- Provide program audit training to REMS Associate Auditors
- Maintain professional communication with clients, sponsors, and regulatory authorities
- Manage multiple tasks and priorities according to business needs
- Guide audit teams in addressing findings and contribute to quality improvement with REMS Management and Project Management
- Conduct on-site audits as requested by clients
- Support the Global Quality Compliance team with client and regulatory audits
- Supervise up to five direct reports
Requirements
What you’ll need- Bachelor’s Degree preferred
- At least three (3) years of experience in pharmacy auditing, compliance, or a related field within the pharmaceutical and/or healthcare industry
- Strong understanding of pharmaceutical industry practices, including Risk Evaluation and Mitigation Strategies [REMS] guidelines and FDA regulatory requirements and industry standards
- Ability to work independently without supervision
- Strong attention to detail and analytical skills
- Proficiency in Microsoft Office suite
- Strong organizational and time management skills
- Willingness to learn and adapt to new processes and regulations
- Ability to work efficiently and prioritize tasks effectively
- Strong problem-solving abilities
- Adherence to ethical standards and confidentiality protocols
- Ability to maintain composure and professionalism under pressure
- Willingness to travel up to 10%
Benefits
Comp & perks- Remote opportunities
- Competitive salaries
- Growth opportunities for promotion
- 401K with company match*
- Tuition reimbursement
- Flexible work environment
- Discretionary PTO(Paid Time Off)
- Paid Holidays
- Employee assistance programs
- Medical, Dental, and vision coverage
- HSA/FSA
- Telemedicine(Virtual doctor appointments)
- Wellness program
- Adoption assistance
- Short term disability
- Long term disability
- Life insurance
- Discount programs