Vice President, Capital Markets, Fixed Income, Compliance Testing
FINRA
Associate Director, Clinical and Safety Quality Compliance
Takeda
full-time
Posted on:
Location Type: Hybrid
Location: Boston • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $153,600 - $241,340 per year
Job Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Ensure compliance to Regulatory Intelligence Procedures
- Execute the regulatory intelligence process in partnership with compliance teams
- Implement change control for new and revised regulations
- Oversee reviews and closure of routine and complex change controls
- Provide data insights to emerging regulations and compliance metrics
- Participate in enterprise-wide projects and initiatives
- Support implementation of new and revised processes across CPMQ
- Contribute to the Clinical and Safety Quality Compliance strategy as part of the Leadership Team
Requirements
- BSc in a scientific or allied health/medical field (or equivalent degree)
- Minimum of 7 years of increasing responsibility and relevant experience in the global pharmaceutical industry
- At least 3 years of experience in GCP Quality/Compliance
- Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations (FDA, EU, MHRA, PMDA, ICH)
- Successful development and implementation of a clinical or pharmacovigilance audit program
- Experience hosting/leading regulatory inspections and remediation activities on a global level
- Skilled in managing global, cross-functional projects
- Successful management of business transformation/change management initiatives
- Excellent communication skills and active listening skills
- Outstanding problem-solving abilities
- Fluency in written and spoken English, additional language skills a plus
Benefits
- Medical, dental, vision insurance
- 401(k) plan with company match
- Short-term and long-term disability coverage
- Basic life insurance
- Tuition reimbursement program
- Paid volunteer time off
- Company holidays
- Well-being benefits
- Up to 80 hours of sick time per calendar year
- Up to 120 hours of paid vacation for new hires
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GCP QualityGCP regulationsGVP regulationspharmaceutical developmentmedical affairsclinical audit programpharmacovigilance audit programregulatory inspectionschange managementdata insights
Soft skills
communication skillsactive listeningproblem-solvingleadershipproject managementcollaborationorganizational skillsadaptabilitycritical thinkinginterpersonal skills
