患者さんのためにあなたの力を発揮してください
※フルリモート不可/Hybrid work model
※Please check if the candidate has applied for a job at UCB in the past year. 一年以内のご応募歴を必ずご確認ください。
※Please make English and Japanese resume combined in one document to submit 英語と日本語の書類を一つに纏めてご提出ください。
※If you have any questions, please contact recruiting team 質問がございましたら採用チームまでお問い合わせください
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.
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.
患者さんのために価値を創造し、あなたの力を発揮して「その先」に進む準備はできていますか？もしそう思われるなら、ぜひご応募ください！
UCBについて
UCBは神経学と免疫学に特化したグローバルなバイオ医薬品企業です。UCBは、世界各地に約8,500人の従業員を擁し、患者さんに触発され、科学を原動力としています。
UCBで働く理由
UCBでは、単に仕事をこなすだけでなく、価値を創造します。私たちは、患者さんのために前進し、協力し、革新することを恐れません。UCBには、思いやりがあり、協力的な社風があります。そこでは、誰もが仲間とともに尊重され、ベストを尽くす機会を公平に与えられています。私たちは、患者さん、従業員、地球のいずれに対しても、常に人間的な視点に立ち、患者さんのために価値を創造する「その先」を目指します。UCBで働けば、自分が成長できる場所を発見し、自分の可能性を最大限に発揮するために自分のキャリアパスを切り開く自由を得ることができます。
UCBにおけるサステナビリティと、それが私たちのビジネスアプローチにどのように統合されているかについては、こちらをご覧ください。
UCBとその子会社は、職場における多様性と包括性を奨励しています。人種／肌の色／宗教／性別／国籍／退役軍人／障害／年齢／性的指向／性自認による差別は行いません。
あなたの強みや能力を発揮するために、日本での職種への応募に特別な配慮が必要な場合は、Ucb_recruit@ucb.com までご連絡ください。その他のお問い合わせの場合、このルートではサポートできませんのでご注意ください。
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