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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates proficiency in audit processes and compliance within the pharmaceutical industry, particularly with Risk Evaluation and Mitigation Strategies (REMS) and FDA regulations. Exhibits strong organizational, analytical, and communication skills to effectively manage documentation and stakeholder interactions.
Highest-signal resume keywords
Audit ReviewREMS ComplianceMicrosoft Office ProficiencyAttention to DetailProblem-Solving
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Audit Questionnaire ReviewDocumentation AccuracyQuality ImprovementSOP ReviewRegulatory Compliance
Soft Skills
Organizational SkillsTime ManagementAdaptabilityProfessionalismCommunication Skills
Industry Keywords
Pharmaceutical IndustryRisk Evaluation and Mitigation StrategiesFDA Regulatory RequirementsStakeholder CommunicationAudit Findings
About the role
Key responsibilities & impact- Provide consistent and effective communication with REMS stakeholders as first-line support and single point of contact
- Maintain accurate and complete documentation of all contacts
- Review audit plans, project-specific procedures, work instructions, audit questionnaires, and supporting documentation
- Complete assigned audit questionnaire reviews within project audit-plan timelines
- Review submitted documentation for completeness, accuracy, and REMS program compliance
- Follow up on documentation deficiencies and actions according to client timelines
- Communicate with stakeholders by phone or email regarding outstanding documentation
- Identify, evaluate, and address audit findings
- Explain audit results to stakeholders
- Complete automated or manual audit review forms
- Assist REMS Senior Auditors with continuous quality improvement
- Record and report audit results and document corrective/preventive actions
- Collaborate with REMS Associate, Auditor, and Senior Auditor teams to share best practices
- Complete SOP review and client-specific training documentation within required timelines
- No supervisory responsibility
Requirements
What you’ll need- Minimum Associate Degree required; Bachelor’s Degree preferred or equivalent work experience
- Basic understanding of pharmaceutical industry practices, including Risk Evaluation and Mitigation Strategies (REMS) guidelines and FDA regulatory requirements
- Proficiency in Microsoft Office suite
- Strong attention to detail and analytical skills
- 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
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