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Speaker Program Compliance Monitor

gsk · Tokyo

New
CDI Senior 🇬🇧 English

Job description

About the role

GSK Japan is looking for a Speaker Program Compliance Monitor to provide independent, second-line assurance over its speaker program. The role checks that speaker slide reviews by the Material Excellence (ME) team and event monitoring by the Speaker Program Center of Excellence (CoE) meet the MHLW Guidelines on Promotion Information Provision Activities, the JPMA Code and GSK policies, and helps the program scale safely with prevention-focused controls.

Key responsibilities

  • Monitor speaker slide decks after ME review and before final approval, assessing review quality against the MHLW Guidelines, the 70:30 GSK slide rule, approved labelling and GSK review standards.
  • Attend national and regional speaker events (on-site and online, including evenings and weekends) on a risk-based sample to verify that the CoE detects and corrects deviations.
  • Identify potential MHLW Guideline deviations (e.g. exaggerated efficacy, off-label or unbalanced statements) and confirm they are corrected promptly.
  • Measure and report KPIs such as slide revision rate, CoE miss rate and right-first-time quality, with trend analysis by brand, speaker and deviation type.
  • Escalate significant or repeat findings to the Compliance Business Partner, Supervisory Division and business owners, and track corrective actions.
  • Give structured feedback to ME reviewers and CoE monitors, contribute to case-study training and capability assessments, and recommend preventive improvements to briefings, slide templates, review manuals and checklists.
  • Support pilot testing of AI-assisted monitoring tools and maintain audit-ready records for MHLW CAPA commitments and internal audits.

Required profile

  • Bachelor's degree in life sciences, pharmacy, medicine/nursing, law or a related field; a pharmacist licence or advanced degree is preferred.
  • 3+ years in the pharmaceutical industry in compliance, monitoring, promotional material review, medical information/affairs or a related function, with hands-on use of the MHLW Guidelines and the JPMA Code.
  • Strong knowledge of the MHLW Guidelines, Pharmaceutical and Medical Device Act advertising rules and the JPMA Code.
  • Native-level Japanese and business-level English (written and spoken).
  • Legal right to work in Japan.

Required skills

  • Analytical skills to track KPIs, spot trends and write concise reports.
  • Clear, constructive feedback and coaching skills.
  • Flexibility to travel nationally and to attend evening/weekend events; comfort with digital and AI-assisted monitoring tools.

What we offer

  • Full-time permanent position at GlaxoSmithKline K.K. in Tokyo, with flexible working hours and up to 2 days of remote work per week.
  • 3-month probation period, annual paid leave, eligible for social insurance and a bonus once per year.
  • Commuting allowance provided.

Questions fréquentes

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Le contrat proposé est un CDI basé à Tokyo.
Source : ats:workday

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Published 11時間前

Expires 1ヶ月後

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gsk

Tokyo