Study Lead, Post-marketing Surveillance & Strategic Management, Japan Medical Office / ジャパンメディカルオフィス PMSストラテジックマネジメント スタディリード

📌 Core Information

🔹 Job Title: Study Lead, Post-marketing Surveillance & Strategic Management, Japan Medical Office

🔹 Company: Takeda

🔹 Location: Tokyo, Tōkyō, Japan

🔹 Job Type: On-site

🔹 Category: Not Specified

🔹 Date Posted: Tue Apr 01 2025

🔹 Experience Level: 3-5 years

🔹 Remote Status: Hybrid

📌 Essential Job Details

🚀 Job Overview

Key aspects of this role include:

• Leadership in post-marketing surveillance for pharmaceuticals.
• Ensuring compliance with regulatory requirements and Takeda's policies.
• Engagement in strategic management across various teams.
• Promotion of operational excellence and evidence generation.

ASSUMPTION: It is assumed that the role requires significant interaction with cross-functional teams and international stakeholders, given the global nature of the business and the specified requirements for English proficiency and leadership skills.

📋 Key Responsibilities

✅ Execute regulatory requirements related to post-marketing surveillance.

✅ Ensure compliance with processes leading up to re-examination and new drug application approvals.

✅ Plan, implement, and report on PMS results and evidence generation.

✅ Lead or participate in cross-functional initiatives.

✅ Develop business models and conduct PMS planning, execution, and result publication.

ASSUMPTION: Responsibilities may involve extensive collaboration with third-party organizations and government regulatory bodies to support PMS and regulatory submission processes.

🎯 Required Qualifications

Education: Bachelor's degree or higher

Experience: 3-5 years in GCP or GPSP, with preferred experience in regulatory submissions or new drug approvals.

Required Skills:

• Leadership
• Ownership
• Decision Making

Preferred Skills:

• Experience in pharmaceutical industry-specific project management.
• Proficiency in data management and medical writing.

ASSUMPTION: It is assumed that the candidate will need to possess a proactive approach to aligning PMS operations with emerging industry trends and standards.

💰 Compensation & Benefits

Salary Range: Not specified, aligned with industry standards for pharmaceutical leadership roles in Japan.

Benefits:

• Commutation allowance and housing subsidies
• Annual salary increase and biannual bonuses
• Comprehensive social insurance and retirement plans

Working Hours: 9:00-17:30 with office flexibility; possible telework and flextime options.

ASSUMPTION: The benefit package is designed to attract experienced professionals by offering competitive compensation typical of large multinational companies.

📌 Applicant Insights

🔍 Company Context

Industry: Pharmaceutical Manufacturing, focused on biopharmaceutical R&D.

Company Size: 10,001+ employees, providing vast career advancement opportunities.

Founded: 1781, with a rich history of innovation and leadership in the pharmaceutical sector.

Company Description:

• Global leader in biopharmaceutical innovations.
• Values-driven organization with a focus on integrity and patient welfare.
• Committed to diversity and inclusion.

Company Specialties:

• Pharmaceuticals
• Therapeutics
• Oncology

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

ASSUMPTION: The company's commitment to values such as Takeda-ism suggests a work environment that encourages ethical decision-making and a focus on the societal impact of their products.

📊 Role Analysis

Career Level: Experienced professional level, focused on strategic leadership within PMS.

Reporting Structure: Likely reports to senior medical management within Takeda's Japan Medical Office.

Work Arrangement: Predominantly on-site with flexibility for remote work, depending on project needs.

Growth Opportunities:

• Potential to lead larger teams or manage larger strategic initiatives.
• Opportunities for global exposure and cross-functional collaborations.
• Professional development through advanced training programs.

ASSUMPTION: With the industry's evolution, there may be new roles or advancements in regulatory affairs or clinical data strategy.

🌍 Location & Work Environment

Office Type: Modern corporate office setting in Tokyo.

Office Location(s): Tokyo headquarters, with potential travel to other offices.

Geographic Context:

• Located in a major global business hub.
• Proximity to key industry and regulatory bodies in Japan.
• Access to a vibrant professional community and network.

Work Schedule: Predominantly 9:00-17:30, with slight variations based on specific site operations.

ASSUMPTION: The proximity to Takeda’s global offices enhances opportunities for collaboration and learning from a diverse pool of experts.

💼 Interview & Application Insights

Typical Process:

• Initial application through Takeda's job portal.
• Screening by HR and Department Heads.
• Technical and panel interviews with potential colleagues.

Key Assessment Areas:

• Understanding of regulatory compliance in pharmaceutical surveillance.
• Leadership and management capabilities.
• Problem-solving and strategic thinking skills.

Application Tips:

• Highlight regulatory or GCP/GPSP experience in your CV.
• Demonstrate ability to work effectively in cross-cultural environments.
• Prepare examples of strategic initiatives you've led successfully.

ATS Keywords: GCP, GPSP, Regulatory Compliance, Leadership, Pharmaceutical Surveillance.

ASSUMPTION: Insights assume a structured hiring process typical in large multinational organizations focusing on competency and cultural fit.

🛠️ Tools & Technologies

• Clinical Trial Management Systems (CTMS)
• Regulatory Information Management (RIM) tools
• Data analysis software such as SAS or equivalent

ASSUMPTION: Based on the role's focus, it is likely that advanced tools for PMS data analysis and management are utilized.

👔 Cultural Fit Considerations

Company Values:

• Integrity
• Fairness
• Innovation

Work Style:

• Collaborative and team-oriented environment.
• Emphasis on ethical decision-making.
• Encouragement of proactive and strategic thinking.

Self-Assessment Questions:

• Can I navigate complex regulatory environments effectively?
• Am I comfortable leading cross-functional teams?
• Do I have the ability to manage large-scale projects efficiently?

ASSUMPTION: It is assumed that candidates who align with Takeda’s core values and demonstrate a strong team and leadership ethos will make the best cultural fit.

⚠️ Potential Challenges

• Navigating complex regulatory landscapes in Japan and globally.
• Ensuring alignment across diverse cross-functional teams.
• Adapting to the rapid pace of change in pharmaceutical regulations and innovations.
• Balancing multiple strategic projects simultaneously.

ASSUMPTION: Challenges are typical of high-responsibility roles in a leading pharmaceutical company with global operations.

📈 Similar Roles Comparison

• Comparable roles within other global pharmaceutical leaders may require additional regulatory knowledge specific to regional markets.
• Similar positions may have a stronger emphasis on data analysis or project management based on specific organizational needs.
• Some roles may offer more remote work flexibility than described for this position.

ASSUMPTION: Comparisons assume equivalence in responsibilities and industry standing across similar biopharmaceutical companies.

📝 Sample Projects

• Leading post-marketing surveillance strategies for new oncology products.
• Coordinating GPSP compliance initiatives with international partners.
• Developing innovative business models for post-marketing research.

ASSUMPTION: Sample projects are inferred from typical functions within the post-marketing surveillance departments.

❓ Key Questions to Ask During Interview

• What upcoming regulatory changes may impact this role?
• How does Takeda support career development and professional growth for this position?
• What systems are in place to facilitate collaboration among cross-functional teams?
• Can you describe a successful strategic initiative led by the team recently?
• What measures does Takeda take to ensure data integrity in PMS operations?

ASSUMPTION: Questions are designed to gauge organizational alignment and clarify expectations and support structures.

📌 Next Steps for Applicants

To apply for this position:

• Submit your application through this link
• Prepare a tailored resume highlighting relevant experience and skills.
• Write a cover letter addressing Takeda's core values and the role's requirements.
• Review common pharmaceutical regulatory requirements.
• Reach out to current employees on professional networks for insights and advice.

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