Global Pharmaceutical Company
- 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.
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
- 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
9 Million Yen ~ 12 Million Yen
(Experiences and skills will be considered)
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