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Senior Study Lead, Post-marketing Surveillance & Strategic Management, Japan Medical Office / ジャパンパディカルγ‚ͺフィス PMSγ‚Ήγƒˆγƒ©γƒ†γ‚Έγƒƒγ‚―γƒžγƒγ‚Έγƒ‘γƒ³γƒˆ シニをスタディγƒͺード

Takeda
Full-time
On-site
Tokyo, Tōkyō, Japan
🌐 Digital Marketing

πŸ“Œ Core Information

πŸ”Ή Job Title: Senior Study Lead, Post-marketing Surveillance & Strategic Management, Japan Medical Office

πŸ”Ή Company: Takeda

πŸ”Ή Location: Tokyo, Tōkyō, Japan

πŸ”Ή Job Type: On-site

πŸ”Ή Category: Not Specified

πŸ”Ή Date Posted: April 2, 2025

πŸ”Ή Experience Level: 5-10 years

πŸ”Ή Remote Status: Hybrid

πŸ“Œ Essential Job Details

πŸš€ Job Overview

Key aspects of this role include:

  • Leading post-marketing surveillance studies
  • Ensuring compliance with GPSP and regulatory requirements
  • Enhancing evidence generation and data utilization
  • Developing innovative approaches to lead the industry

ASSUMPTION: The role primarily involves strategic management with a focus on regulatory compliance and innovation in post-marketing surveillance. This assumption is based on the emphasis on GPSP and evidence generation in the job description.

πŸ“‹ Key Responsibilities

βœ… Execute regulatory requirements related to post-marketing surveillance

βœ… Ensure strict adherence to compliance standards

βœ… Lead cross-functional initiatives

βœ… Propose and implement new business models

βœ… Submit applications for product re-examinations

ASSUMPTION: The responsibilities listed focus heavily on regulatory and compliance activities due to the post-marketing nature of the role.

🎯 Required Qualifications

Education: Bachelor's degree or higher

Experience: At least 5 years in GCP/GPSP roles; experience with study lead, project management, data management, or statistical analysis

Required Skills:

  • Leadership and decision-making abilities
  • Excellent communication skills
  • Experience managing cross-functional projects

Preferred Skills:

  • Experience in regulatory submissions or new drug applications
  • Ability to work with global partners

ASSUMPTION: Preferred skills extend to regulatory submission experiences to enhance the capability of handling product life cycles.

πŸ’° Compensation & Benefits

Salary Range: Not specified (industry context suggests competitive compensation typical for senior roles in pharmaceutical companies)

Benefits:

  • Commutation, housing, and overtime allowances
  • Annual salary increase and semi-annual bonus payments
  • Comprehensive health insurance and retirement plans

Working Hours: Standard 40 hours per week with some flexibility and potential hybrid work

ASSUMPTION: The listed benefits and working hours assume consistency with global standards at Takeda, providing support for work-life balance.

πŸ“Œ Applicant Insights

πŸ” Company Context

Industry: Pharmaceutical Manufacturing

Company Size: 10,001+ employees (indicative of a large, well-established enterprise with global influence)

Founded: 1781

Company Description:

  • Committed to transforming lives through pharmaceutical innovation
  • Values-driven approach built on integrity and patient care
  • Emphasizes diversity and inclusion within a large global structure

Company Specialties:

  • Pharmaceuticals
  • Therapeutics
  • Oncology and vaccines

Company Website: https://www.takeda.com/

ASSUMPTION: Company's global and historical presence suggests stability and vast resources for innovation in pharmaceuticals.

πŸ“Š Role Analysis

Career Level: Senior Leadership

Reporting Structure: Likely reports to executives or senior departmental heads

Work Arrangement: Combination of on-site and flexible remote work arrangement

Growth Opportunities:

  • Potential for leadership roles in global offices
  • Opportunities to lead innovative projects and partnerships
  • Access to broad range of expertise within a global network

ASSUMPTION: Growth is likely supported by Takeda's expansive global reach and commitment to leadership development.

🌍 Location & Work Environment

Office Type: Modern corporate office with potential for flexible workspace arrangements

Office Location(s): Multiple global locations providing diverse cultural experiences

Geographic Context:

  • Located in Tokyo's international and business-rich environment
  • Access to vibrant cultural and business sectors
  • Proximity to other Asian markets for regional collaboration

Work Schedule: Aligns with corporate norms; 9 AM to 5:30 PM standard with flexibility

ASSUMPTION: Tokyo’s status as a business hub implies high accessibility and potential for international collaboration.

πŸ’Ό Interview & Application Insights

Typical Process:

  • Initial application submission
  • Screening interviews with HR and technical teams
  • Panel interviews with cross-functional teams

Key Assessment Areas:

  • Technical knowledge in GCP/GPSP
  • Leadership and management capabilities
  • Problem-solving skills and strategic thinking

Application Tips:

  • Emphasize your regulatory and compliance expertise
  • Highlight past leadership in similar projects
  • Demonstrate global mindset and cross-cultural skills

ATS Keywords: Leadership, GPSP, Compliance, Project Management

ASSUMPTION: The interview process is comprehensive given the seniority of the role and the focus on regulatory expertise.

πŸ› οΈ Tools & Technologies

  • Regulatory compliance software
  • Data management systems
  • Project management tools

ASSUMPTION: Assumed usage of advanced software for regulatory and data management consistent with industry standards.

πŸ‘” Cultural Fit Considerations

Company Values:

  • Integrity and honesty
  • Dedication to patient care
  • Commitment to diversity and inclusion

Work Style:

  • Collaborative and cross-functional environment
  • Proactive and innovation-driven
  • Flexibility to adapt in a fast-paced sector

Self-Assessment Questions:

  • How do you lead cross-functional teams?
  • What’s your approach to ensuring regulatory compliance?
  • How do you drive innovation in a regulated environment?

ASSUMPTION: Values and work style align with Takeda's emphasis on integrity and patient-centered care in dynamic global settings.

⚠️ Potential Challenges

  • Navigating complex regulatory landscapes
  • Leading initiatives in a highly competitive market
  • Balancing innovation with compliance
  • Engaging diverse stakeholders

ASSUMPTION: Challenges are typical of high-level roles in a regulated industry, demanding both innovation and adherence to compliance.

πŸ“ˆ Similar Roles Comparison

  • Similar roles may require less post-marketing focus but comparable senior leadership skills
  • Differences may include industry-specific regulatory expertise
  • Opportunities in smaller firms may offer more direct cross-functional involvement

ASSUMPTION: Comparative analysis assumes an overlap in leadership focus but variance in market and regulatory exposure.

πŸ“ Sample Projects

  • Leading a global post-marketing surveillance initiative
  • Developing innovative compliance tools
  • Conducting cross-market regulatory alignments

ASSUMPTION: Project examples reflect standard expectations for roles of this nature involving strategic oversight in pharmaceuticals.

❓ Key Questions to Ask During Interview

  • How does Takeda support regulatory knowledge sharing among global teams?
  • What is the company's approach to innovation in post-marketing surveillance?
  • How do cross-functional teams collaborate on surveillance projects?
  • What are the main challenges facing this department right now?
  • How does Takeda encourage ongoing professional development in this role?

ASSUMPTION: These questions are crafted to provide insights into company support systems and strategic directions.

πŸ“Œ Next Steps for Applicants

To apply for this position:

  • Submit your application through this link
  • Prepare for initial screenings by HR
  • Research Takeda's recent developments in PMS
  • Gather examples of past leadership roles in similar settings
  • Highlight your commitment to compliance and patient care

⚠️ This job description contains AI-assisted information. Details should be verified directly with the employer before making decisions.