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Alexion

Global biopharmaceuticals focusing on rare diseases

Associate Director Promotion Audit

Regulatory Compliance & EthicsConfirmed live in the last 24 hours
Full-timeTokyo, JapanNo salary listedIn-person

About the Job

Requirements

  • At least 10 years of experience working at a pharmaceutical company.
  • Practical experience reviewing promotional materials and events at a pharmaceutical company, or practical experience in a compliance-related department.
  • Knowledge of pharmaceutical-industry compliance, including the Pharmaceuticals and Medical Devices Act (pharmaceutical advertising regulations), the Guidelines for Provision of Sales Information, the Fair Competition Code, and preparation guidelines, as well as comprehensive knowledge of pharmaceutical companies’ external activities.
  • Business-level ability to use Excel, Word, PowerPoint, and Outlook.
  • Japanese language ability at daily-conversation level and English ability to write and read business documents.

Responsibilities

  • Build, maintain, and manage systems to ensure that Alexion Pharma GK’s corporate activities comply with applicable laws, regulations, and industry self-regulatory rules.
  • Serve as the supervisory department specified under the Guidelines for Provision of Sales Information for Prescription Drugs.
  • Serve as the contact department for the Fair Trade Council of the Japan Pharmaceutical Manufacturers Association.
  • Review promotional materials and related event applications for compliance with laws, codes, and internal rules, and provide final approval.
  • Lead the establishment and ongoing monitoring of the operational framework for the Guidelines for Provision of Sales Information, including operating standards, approval workflows, and record management; implement corrective actions and training as needed.
  • Coordinate with industry organizations and internal and external stakeholders, and promote internal communication of updated regulations and guidance.
  • Monitor sales-information provision activities, including establishing and reviewing supervisory systems and their operation, managing records, and following up on corrective measures.
  • Review and provide final approval for various materials.
  • Review and provide final approval for various event applications.
  • Create and manage internal compliance rules, including standard operating procedures; design and standardize approval processes and establish operating standards under the Guidelines for Provision of Sales Information.
  • Plan and deliver compliance-related training.
  • Respond to compliance-related consultations from relevant departments.
  • Consult, collaborate, and coordinate with compliance, legal, and executive teams as needed.
  • Coordinate with and serve as the contact for the Fair Trade Council, and communicate and disseminate external guidance internally.

Desired Qualifications

  • At least 3 years of experience creating approved materials in a marketing or medical department at a pharmaceutical company.
  • At least 3 years of experience leading events such as lectures, co-hosted academic conferences, or advisory board meetings.
  • Ability to communicate effectively within the department and with other departments.
  • Ability to deliver clear presentations in training sessions, meetings, and similar settings.
  • Knowledge of disease areas in which Alexion Pharma GK operates.
  • Ability to make evidence-based, objective, and fair judgments and explain them logically and persuasively.
  • Experience coordinating or negotiating with industry organizations such as the Fair Trade Council, or leading internal dissemination and training on external guidance.

About the Company

Alexion

Global biopharmaceuticals focusing on rare diseases

Alexion, now the rare disease group within AstraZeneca, develops and sells therapies for rare and ultra-rare diseases by targeting the complement immune system. Its drugs, such as Soliris and Ultomiris, inhibit the C5 component to slow or stop disease processes, while Strensiq and Kanuma address specific metabolic disorders. It differentiates itself through a deep focus on complement biology, pursuing first- or best-in-class therapies, and using a strategy that blends internal R&D with acquisitions to expand its pipeline. Its goal is to improve outcomes for patients with rare diseases and bring these therapies to a broader international market using AstraZeneca’s scale and capabilities.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Boston, MA
Founded
1992

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