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Director, Global Medical Information & Review

7+ years
Not Disclosed
10 Nov. 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

The Director, Global Medical Information & Review position at Takeda Oncology is a critical leadership role within the Global Medical Affairs Oncology (GMAO) team. This role drives the strategy, processes, and team performance related to medical information and review activities for a broad portfolio of oncology products, both marketed and pipeline. The successful candidate will be responsible for integrating advanced systems, fostering change management, and maintaining Takeda's reputation for high-quality medical communications.


Key Responsibilities

Leadership and Strategy

  • Lead, manage, and develop a high-performing global team, ensuring alignment with Takeda’s oncology goals.
  • Establish and oversee budgets, resource allocation, and outsourced services to support organizational needs.
  • Create and execute functional strategies and goals aligned with business objectives.

Medical Information Systems & Processes

  • Implement a global medical information system tailored for oncology, ensuring integration and optimization across regions and functions.
  • Develop global core response documents (GCRDs) that align with regional and local needs, ensuring strategic consistency.
  • Oversee contact center operations for the U.S., continuously assessing and implementing technological advancements.

Medical Review Oversight

  • Manage the team responsible for advanced medical and scientific reviews of non-promotional materials.
  • Ensure the efficiency and compliance of review processes, identifying opportunities for improvement.

Stakeholder Collaboration

  • Partner with key functions (e.g., Pharmacovigilance, Quality Assurance, Therapeutic Leads) to maintain high operational standards.
  • Align medical information activities with alliance partners and internal stakeholders for products in collaborations.

Compliance and Reporting

  • Ensure adherence to global regulations and Takeda’s SOPs, maintaining up-to-date processes reflecting industry standards.
  • Create dashboards and reports to monitor performance metrics and compliance for senior management.

Congress and Signal Management

  • Oversee booth support and scientific coverage at medical congresses, collaborating with global strategy and brand teams.
  • Establish a robust system to detect and respond to strategic signals in medical information requests.

Qualifications

Required:

  • Education: Bachelor's degree in a scientific discipline.
  • Experience:
    • 7+ years in healthcare or related fields.
    • 5+ years in medical affairs or publications planning, with 3+ years of budget or people management experience.
    • Significant expertise in clinical trial data interpretation and global medical information systems.
  • Proven leadership, teamwork, and decision-making skills.
  • Advanced knowledge of global regulations impacting medical affairs.
  • Proficient in Microsoft Office and medical information/reporting tools.

Preferred:

  • Advanced degree (PhD, PharmD, or equivalent) in a scientific discipline.
  • Oncology therapeutic area experience.
  • Post-doctoral residency or fellowship.
  • Experience in global integration of medical information systems.

Travel and Work Environment

  • Willingness to travel (domestic and international) approximately 5-30% of the time.
  • Hybrid work environment per Takeda's policy.

Compensation and Benefits

Takeda offers a competitive compensation package, including:

  • Comprehensive health benefits.
  • 401(k) plan with company match.
  • Paid vacation, sick time, and volunteer hours.
  • Professional development opportunities.

Diversity and Inclusion

Takeda is committed to fostering a diverse and inclusive workforce, providing equal opportunities regardless of background, identity, or protected status.


This role offers an opportunity to lead strategic medical information and review activities in a cutting-edge oncology environment. Let me know if you’d like assistance preparing for this position!