Full-Time
Senior Associate Operational Excellence & Compliance
Integrated Resources
501-1,000 employees
No salary listed
Cambridge, MA, USA
In Person
 Biology & Biotech (2) |
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- In depth understanding of clinical research and pharmacovigilance operations and regulations, including knowledge of ICH Good Clinical Practice, Good Pharmacovigilance Practice, and FDA, European Union, and Rest of World regulations
- 5+ years of experience in clinical research and/or pharmacovigilance, including compliance
- Team player with excellent interpersonal skills
- Strong attention to detail and excellent communication skills, both written and oral
- Bachelor's Degree required
- Collaborates with internal departments on implementation of quality principles and regulatory requirements related to Good Pharmacovigilance Practice
- Coordinates pharmacovigilance-related aspects of inspection readiness activities
- Assists other departments in addressing audit findings and development of Corrective and Preventive Actions (CAPAs)
- Participates in development and reporting of compliance metrics related to Good Pharmacovigilance Practice activities
- Conducts effectiveness checks and internal assessments of current processes and procedures to identify potential process improvement opportunities
- Assist in hosting regulatory inspections related to pharmacovigilance
- Applies departmental Standard Operating Procedures and participates in the development of departmental Standard Operating Procedures, as appropriate
- Responsible for maintenance, update, and change control of the Pharmacovigilance System Master File (PSMF)
- Monitors commitments from internal audit and regulatory inspection findings
- Performs late case investigations and writes delayed case reports
- Master's Degree preferred
- Excellent knowledge of Standard Operating Procedures and auditing/compliance background preferred
Company Size
501-1,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Edison, New Jersey
Founded
1996
Simplify's Take
What believers are saying
- Certification boosts appeal to quality-focused healthcare organizations.
- Reskilling programs cut time-to-hire amid workforce shortages.
- Positions IRI among 15,000 Joint Commission-accredited elite firms.
What critics are saying
- Certification lapses in 12-18 months from failed onsite review.
- Patient complaints trigger decertification and client losses in 6-12 months.
- AMN Healthcare captures IRI's mid-sized clients in 12-24 months.
What makes Integrated Resources unique
- Joint Commission Gold Seal certifies IRI's staffing compliance since 2009.
- AI tool Nova hybridizes with reskilling to close healthcare skills gaps.
- Focuses on diversity hiring and performance monitoring for elite placements.
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Benefits
Wellness Program
Mental Health Support
Flexible Work Hours
Phone/Internet Stipend
Home Office Stipend
Conference Attendance Budget
Company News
Edison, New Jersey - Integrated Resources Inc. has earned The Joint Commission's Gold Seal of Approval(R) for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards.
Integrated Resources Inc. has earned The Joint Commission’s Gold Seal of Approval ® for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards.