Associate Director, Clinical PV, Medical Quality
Takeda
full-time
Posted on:
Location Type: Office
Location: Boston • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $153,600 - $241,340 per year
Job Level
Senior
About the role
- Provides oversight from a clinical research and pharmacovigilance perspective of regulated post-authorization activities in the commercial business units and affiliates.
- Contributes to and implements the engagement strategy among R&D, Business Units, and affiliates and Quality.
- Drive a fit-for-use global Quality framework and enables them to deliver their clinical research and pharmacovigilance-related regulated activities with high compliance and agility.
- Ensure that the Global Quality Audit functions consider clinical research and pharmacovigilance regulated activities.
- Participate in the audit planning and be a proactive partner in the mitigation of identified risks.
- Provide expert input in high to medium and/or potential systemic quality investigations in the business units and affiliates.
- Escalate issues of potentially critical non-compliance to Senior Management.
- Support inspections to ensure that any risks are well-communicated within the GPD and Global Quality organizations.
- Analyze and communicate relevant risks within the GPD and Global Quality organizations.
- Ensure that post-authorization and commercial perspectives are analyzed and understood using CPMQ data trends and insights.
Requirements
- BSc in a scientific or allied health/medical field (or equivalent degree).
- Minimum of 10 years of increasing responsibility and relevant experience in the global pharmaceutical industry.
- At least 3 years of Quality/Compliance.
- Advanced knowledge of clinical research, medical affairs activities and pharmaceutical commercial operations.
- Experience must include cross-functional and enterprise collaborations and initiatives, particularly between R&D and Commercial.
- Experience working within complex organizations, working closely with senior staff and executive level colleagues.
- Excellent communication skills to convey message, whether through public speaking, writing, or interpersonal interactions.
- Exceptional active listening skills to understand the needs and concerns of others.
- Outstanding ability to apply critical thinking and problem-solving abilities to address challenges and advocate for solutions.
- Fluency in written and spoken English, additional language skills a plus.
Benefits
- U.S. based employees may be eligible for short-term and/or long-term incentives.
- U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and 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.
- New hires eligible to accrue up to 120 hours of paid vacation.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchpharmacovigilanceQuality/Compliancemedical affairspharmaceutical commercial operationsrisk analysisaudit planningdata trends analysissystemic quality investigationspost-authorization activities
Soft skills
communication skillsactive listeningcritical thinkingproblem-solvinginterpersonal skillscollaborationagilityleadershipstrategic thinkingstakeholder engagement