メディカル・バイオ - メディカルアフェアーズ

JOB SUMMARY

 Engage for Medical Governance and Processes in Japan
 Primary Country Signatory for Country Clearance Committee (CCC) and Country Lead for the Global Clearance system, Source Clear
 Make sure all communication materials reviewed and approved are within the set expectation in line with company policies, UCB code of standards, local laws, regulations, and guidelines such as "GUIDELINE FOR SALES INFORMATION PROVISION ACTIVITIES"
 Responsible person for CCC secretariat
 Make sure efficient / effective review, update, approval, archiving, and expiration management processes are in place within Medical Integrity
 Interface and manager for co-promotion partner companies in Medical Integrity
 Adjust sales partners’ processes are aligned to the MAH/UCB Japan’s expectations
 Leader to propose/establish new mechanisms for local medical governance
 Manage and overcome the facing challenges such as "GUIDELINE FOR SALES INFORMATION PROVISION ACTIVITIES", revision for global SOPs for GCC/EUCC/CCC and local business model change
 Support all SOPs, associated instructions, forms for Medical Governance are established / revised for adequate executions

MAJOR ACCOUNTABILITIES

 As a primary Country Signatory for CCC and Country Lead for Source Clear:
 Ensure the CCC is in place for review and approval of local communications and local minimal adaptations of global communications in accordance with company policies, UCB code of standards for Promotional (sop-ai-008517) or Educational (sop-ai-008518) or Press Communications (sop-ai-012672).
 Ensure that all communications comply with local laws, regulations, and guidelines as well and that the stricter applies in case of conflict with the UCB Policies and UCB codes of standards.
 Ensure that all communications are reviewed and approved in the global clearance system, Source Clear, within timelines, and that a unique identifier code is provided to each approved communication as defined locally.
 Ensure archiving for a minimum of 6 years of the reviewed and approved communication as well as evidence using the global clearance system.
 Ensure that the approved communications are updated in case of a change in label, safety issue, change in regulation, litigation, or any other change requested by GCC/EUCC or CCC members.
 Ensure expiration date is provided according to the decision from CCC approval and expiration status is managed.
 Ensure timely improvement of the medical operation's process /system to manage and overcome the facing challenges such as "GUIDELINE FOR SALES INFORMATION PROVISION ACTIVITIES", revision for global SOPs for GCC/EUCC/CCC and local business model change.
 Support head of Medical Operation
 Ensure all SOPs for Medical Governance are established/revised for adequate executions.
 Ensure propose / establish new mechanisms / systems /processes for medical governance.

■休日：完全週休二日制, 祝日, 夏季休暇, 年末年始

EDUCATION & QUALIFICATION

Education Level : Bachelor's Degree
Master's Degree

Life science, data management, medical writing etc.

Experience :

 Substantial and broad-ranging experience in the pharmaceutical / biotechnology area including significant time working in Medical / Compliance -related areas.
 Experience in leading the compliance review for Medical communications that internal and external use such as promotional, educational, and publication with depth of understanding of global / local policies, procedures, guidelines, and regulations.
 Experience in managing function that handles medical information enquiries with depth of understanding of global / local policies, procedures, guidelines, and regulations.
 Minimum of 5 years working in Medical-related areas, 5 years working in Compliance and/or a combination of the two.

COMPETENCIES

 In depth knowledge and understanding of Medical Affairs tasks in the pharmaceutical industry and of applicable regulations and guideline, and practice. Able to apply theoretical knowledge in practical situations
 Leadership to implement grants programs that foster increased understanding of science, clinical, and healthcare issues and contribute to the enhancement of patients care.
 Confident and good communicator, able to communicate with interdepartmental stakeholders and represent company with KOLs, external business partners and deliver clear verbal and written messages in a constructive and effective manner to a variety of relevant.
 Effective verbal and written communication skills. Should be able to adapt communication style to suit different audiences/cultures.
 High level of personal integrity with a strong commitment to medical compliance and ethical behavior.
 Demonstrated self-starter, highly reliable, with positive, enthusiastic approach, ability to manage own workload, set priorities within the remit allocated by management and willingness to accept responsibility.
 Fluent in written and spoken Japanese / English for business use for excellent communication with the global counterpart.
 Ability to oversight compliance management process / system and medical operations in support of compliance culture and operational output, balancing requirements against internal / external expectations.
 Good negotiator, able to influence and obtain cooperation from colleagues, external business partners and other stakeholders.
 Action oriented person.
 Ability to proactively identify, assess, mitigate and manage potential risks to add value for medical operational practice and maintain UCB's reputation.

■職種未経験者：不可