Legal & Compliance Manager
Minato-ku, Tokyo-To, JP
Job Description:
Position: Manager, Legal & Compliance
Department/Section: Legal & Compliance
Reference & position: Director, Head of Legal & Compliance
Manager for: NA
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Purpose of the job:
The purpose of this position is to support the organization in further developing its Compliance Program with appropriate corporate governance, internal control, practices and procedures. Under the supervision of Head of Legal and Compliance in Lundbeck Japan (LuJ), the responsible person will (i) conduct compliance monitoring on LuJ’s activities and (ii) implement and maintain compliance and relevant controls including review and approval procedures as well as (iii) conduct training and communication, where the objective thereof is to ensure that LuJ remains in compliance with applicable laws and regulations as well as industry code, detects material breaches and takes prompt corrective and preventive actions. The responsible person is also providing advice and solutions to the day to day operations of LuJ’s business from the compliance perspective.
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Responsibilities:
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Compliance monitoring:
(i) Conduct compliance monitoring against both Lu J’s 1) promotional activities to be performed based on the requirement of MHLW Promotion Guideline and 2) transfer-of-value activities, e.g. company-sponsored events to be conducted as per LuJ’s Compliance requirements, and (ii) take corrective actions and/or preventive actions to 1) achieve early correction of non-conformity and 2) more effective proactive control of compliance risks, both of which will lead to promote right behaviors among LuJ employees.
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Responsible for LuJ compliance process:
Provide support to other LuJ departments and approve business activities, e.g. company sponsored events to ensure compliant and ethical interaction with healthcare professionals, healthcare institutions, patients, patient groups and government officials. Of note, LuJ donation process handling would be included in its responsibility.
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Third Party compliance due diligence management:
Provide support to the responsible department or person in conducting due diligence procedures, in accordance with Lundbeck Global SOPs, prior to entering into contracts with external vendors. Manage the contract module in Ariba, and provide training to employees.
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Personal data protection management:
Plan and execute LuJ’s personal data protection-related actions to comply with Lundbeck global requirements as well as Japan Personal Information Protection Act, including conducting trainings to LuJ employees with the support given by external law firm and other vendors.
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Compliance training & communication:
Conduct compliance training and send out compliance communication from time to time.
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Transparency disclosure:
Plan and lead the transparency disclosure-related assignment to make sure that the disclosure on payments to healthcare professionals, healthcare institutions, and patient groups is completed in compliance with applicable industry code and LuJ’s disclosure policy.
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Compliance investigation:
Conduct investigations in accordance with Lundbeck’s global investigation procedure and local investigation procedure, as applicable.
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Nurturing LuJ compliance culture:
Advocate and live Lundbeck’s “always do the right thing” by example, build a proper mindset among LuJ employees and strengthen/maintain a corporate environment based thereupon.
3. Skills and experience:
1) Experience
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At least 3 years of experience as compliance professional responsible for promotional compliance and/or transfer-of-value compliance within the pharmaceutical industry.
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Experience in monitoring, auditing and/or compliance investigation preferred.
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Experience as MR (Medical Representative) and/or MSL (Medical Science Liaison) preferred.
2) Personal skills
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Logical thinking
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Stakeholder management skill, i.e., adaptability and flexibility skills
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In-depth knowledge on healthcare laws and regulation/applicable industry code
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Passion for compliance and integrity
3) Lundbeck Competency “Three Behaviors”
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CURIOSITY
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ADAPTABILITY
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ACCOUNTABILITY
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.