Speaker Program Compliance Monitor

Job Purpose

Provide independent, second-line assurance over the GSK Japan Speaker Program by monitoring the quality of speaker slide reviews performed by the Material Excellence (ME) team and the effectiveness of on-site/online event monitoring performed by the Speaker Program Center of Excellence (CoE). The role verifies that speaker content and event delivery adhere to the MHLW Guidelines on Promotion Information Provision Activities, the JPMA Code and GSK policies, evaluates ME and CoE capabilities, and drives continuous improvement so that the Speaker Program can scale safely with prevention-focused controls.

Key Responsibilities

• Conduct Compliance monitoring of speaker slide decks after ME review and prior to final approval, assessing ME review quality against 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 sampling basis, prioritising first-time and higher-risk speakers, to verify CoE detection and correction of potential deviations.
• Independently identify potential MHLW Guideline deviations (e.g., exaggeration of efficacy, off-label or unbalanced statements) and confirm that corrections are made promptly during or after the event.
• Measure and report monitoring KPIs, including ME slide revision rate, CoE miss rate and right-first-time slide quality, with trend analysis by brand, speaker and deviation category.
• Escalate significant or repeat findings to the Compliance Business Partner, Supervisory Division and relevant business owners in a timely manner, and track resolution of corrective actions.
• Provide structured feedback to ME reviewers and CoE monitors, and contribute to case-study training and capability assessments/certification.
• Identify root causes and recurring themes, and recommend preventive improvements to commercial briefings, GSK slide templates, review manuals and monitoring checklists.
• Support pilot testing and quality validation of AI-assisted tools (e.g., AIM slide screening and live event monitoring) and ensure human oversight of their outputs.
• Maintain complete, audit-ready monitoring records and evidence to support MHLW CAPA commitments, internal audits and management monitoring reports (e.g., RMCB, Annual Confirmation).
• Stay current on MHLW, JPMA and GSK policy updates and apply them consistently in monitoring criteria.

Breadth/Scope of Accountability

Covers Speaker Program activities across GSK Japan brands (Specialty, Respiratory/Immunology, Oncology and Vaccines), including GSK stand-alone and congress co-sponsored events at national and regional levels. Indicative capacity per FTE: c. 100 speaker slide decks per month and 8–10 speaker events per month. Works across Business Unit/Marketing, Speaker Program CoE, Medical/Material Excellence and the Supervisory Division.

*Future scope of job and working location will be determined by company.

Knowledge/ Education/ Previous Experience Required:

A. Educational Background

• Minimum Level of Education: Bachelor's degree
• Area of Specialization: Life sciences, pharmacy, medicine/nursing, law or related discipline
• Why is this level required: Needed to understand scientific and clinical content in speaker slides and presentations, and to interpret regulatory requirements accurately
• Preferred Level of Education: Pharmacist licence or advanced degree (e.g., Master's)
• Preferred Area of Specialization: Pharmacy, life sciences or medical science
• Why preferred: Strengthens the ability to judge efficacy/safety claims, off label risk and balance of scientific information independently

B. Job-Related Experience

Minimum Level of Job-Related Experience Required

3+ years in the pharmaceutical industry in compliance, monitoring, promotional material review, medical information/affairs or a related function, including hands-on application of MHLW Guidelines and the JPMA Code.

Why is this Level of Experience Required?

The role must independently assess the quality of expert reviewers and monitors, which requires practical judgement on promotional content and HCP-facing activities and credibility with business stakeholders.

C. Other Job-Related Skills/ Background

• Strong working knowledge of MHLW Guidelines on Promotion Information Provision Activities, Pharmaceutical and Medical Device Act advertising rules and the JPMA Code.
• Sound judgement, objectivity and courage to raise and escalate concerns.
• Analytical skills to track KPIs, identify trends and write concise reports for management.
• Clear, constructive feedback and coaching skills.
• Native-level Japanese; business-level English (written and spoken).
• Flexibility to travel nationally and to attend evening/weekend events.
• Comfort with digital and AI-assisted monitoring tools.

*Legal right to work in Japan.

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Selection Process

• Application Screening
• Two to Three Interviews
• Background Check

Work Location:
GlaxoSmithKline K.K.
Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

Employment Type: Full-time (Permanent)

Bonus: Eligible (once per year)

Salary Review: Eligible (once per year)

Commuting Allowance: Provided

Insurance Coverage: Eligible for social insurance benefits

Annual Paid Leave: Eligible

Probation Period: 3 months

Working Arrangement: Flexible working hours (Flextime system)

Remote Work: Available (up to 2 days per week)

Skills

Business Acumen, Influencing Without Authority, Insight Generation, Learning Agility, Problem Solving, Risk Management

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact [email protected]. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

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