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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates strong attention to detail and analytical skills while maintaining compliance with REMS guidelines and FDA regulatory requirements. Proficient in documentation management and effective communication with stakeholders to ensure project success.
Highest-signal resume keywords
REMS ComplianceAudit ReviewMicrosoft Office ProficiencyAttention To DetailAnalytical Skills
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 ReviewSOP ReviewQuality ImprovementCorrective Actions Documentation
Soft Skills
Organizational SkillsTime ManagementProblem-Solving AbilitiesProfessionalism Under PressureEffective Communication
Industry Keywords
Pharmaceutical Industry PracticesRisk Evaluation And Mitigation StrategiesFDA Regulatory RequirementsStakeholder CommunicationConfidentiality Protocols
About the role
Key responsibilities & impact- Provide consistent and effective communication to REMS stakeholders as first-line support and single point of contact
- Maintain accurate and complete documentation of all contacts
- Review project-specific documentation, including audit plans, procedures, and work instructions
- 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
- 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
- Formally record and report audit results and document corrective/preventive actions
- Collaborate with REMS Associate, Auditor, and Senior Auditor colleagues to share best practices
- Complete SOP reviews and client-specific training within required timelines
- No supervisory responsibility
Requirements
What you’ll need- Minimum Associate Degree required; Bachelor’s Degree preferred or equivalent work experience
- Strong attention to detail and analytical skills
- Basic understanding of pharmaceutical industry practices, including Risk Evaluation and Mitigation Strategies (REMS) guidelines and FDA regulatory requirements
- 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
- Ability to communicate with stakeholders via phone or email
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