Healthcare Compliance Manager - Pharmaceutical Company

勤務地 Tokyo, Japan
職種 正社員
給与 ¥9000000.00 - ¥12000000.00 per annum
専門 法務・知財・コンプライアンス,
Sub-specialization コンプライアンス, 企業内法務,
お問合せ Makito Toyonaga
参照 JO-1812-408751
see Makito's jobs


[Company Description]
Global Pharmaceutical Company

[Responsibilities]

  • Translating global strategies into local level, based on appropriate local needs, goals and objectives, taking into account local external regulatory trends and environment
  • Acting as a consultant, and where appropriate, or required by the Guide A, assuring review and approval for Health Care Professional (HCP)/Government Official (GO) oriented activities
  • Stimulating and contributing to innovative approaches towards HCP's and GOs consistent with the guidelines A and framework and performing business plan reviews
  • Providing and coordinating appropriate guidance, education, training, and regular communications on the program A to all covered employees
  • Conducting self-assessments and risk assessments to detect process gaps and inconsistencies
  • Executing a testing & monitoring plan in place to assess that the B program is effective
  • Partnering with Corporate Internal Audit to deliver successful audits
  • Establishing and monitoring the progress of the Management Action Plan, and guiding the business partners to close gaps and implement corrective actions
  • Managing day-to-day allegations and investigations
  • Participating in and leading investigations of non-compliance and implementing the escalation process for serious allegations, as appropriate

Other duties may be assigned.

[Requirements]
EDUCATION and EXPERIENCE:

  • Minimum of BA/BS required;
  • Minimum of 7 to 10 years business, legal and/or compliance-related experience
  • Knowledge of laws, regulations and industry standards for Japan

SKILLS and ABILITIES:

  • Fluent in English (reading, writing, verbal)
  • Fluent in Japanese required
  • Breadth of experience in all areas of compliance and regulation
  • Demonstrate strong organizational, interpersonal and communication skills
  • Excels at developing and maintaining effective partnerships and working relationships with key stakeholders at all levels of organization based on an understanding of their concerns, needs and motivations.
  • Deals well with ambiguity

[Preferred Knowledge, Skills and Abilities]

  • Other advanced degree (Master/Ph.D) preferred but not required

[Desired Characteristics]

  • Ability to make and stand by difficult decisions
  • Strong drive for results and solution orientated
  • Independent and objective thinker, able to advance ideas and influence others
  • Manages conflicts in an open and constructive manner
  • High level of integrity with good ethical core values

[Employment Type]
Full time

[Salary]
9 Million Yen ~ 12 Million Yen
(Experiences and skills will be considered)

[Location]
Tokyo


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