Job Description

企業概要

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

求人内容

Missions:

The appropriateness of information provision activities in AbbVie is ensured by assisting in the development of an internal code system/examination review system as a sales information provision activity supervision department in accordance with relevant laws and regulations (pharmaceutical machinery law, proper advertising standards, sales information provision activity guidelines, etc.), industry standards (pharmaceutical cooperation codes, material preparation procedures, fair competition rules, etc.) and AbbVie internal ethics/regulations relating to promotion activities, and communicating with internal and external stakeholders.

Main job description:

1. Operations related to formulation/revision of in-house codes
2. Services related to education/training
3. Operations related to monitoring
4. Deviation-related operations
5. Operations related to challenges/escalations from implementation departments, etc.
6. Examination of various promotional materials
7. Review work for slides of lectures, etc.
8. Pre-examination/review consultation/inquiry handling services
9. Secretariat operations such as the Examination/Supervisory Committee/Scientific Advisory Board/Mutsuki Association

Role details:

1. Formulation and revision of AbbVie's in-house code in accordance with the Pharmaceutical Cooperative Code
2. Planning and implementation of education/training on various codes/rules, etc. related to promotion activities
3. Risk analysis and examination of countermeasures through continuous activity monitoring
4. Deflation related support (including VVR)
5. Response to challenges/escalations from implementation departments, etc.
6. Establishing review standards for lecture slide reviews and ensuring consistency of review comments
7. Appropriate review of examination standards and processes, and disseminate and thoroughly implement them to the commercial department
8. Pre-examination consultation and response to inquiries
9. Functional operation support for review and supervisory committees and scientific advisory boards
10. Collection of information on other companies through Mutsuki Association

Missions:

プロモーション活動に関わる関連法規（薬機法、適正広告基準、販売情報提供活動ガイドライン等）、業界規範（製薬協コード、資材作成要領、公正競争規約等）やアッヴィ社内倫理/規則に則り、販売情報提供活動監督部門として、社内コード体制/審査レビュー体制の整備を補佐し、社内外ステークホルダーとのコミュニケーションを図ることで、アッヴィにおける情報提供活動の適切性を確保する。

Main Job description:

1. 自社コードの策定/改定に関する業務
2. 教育/トレーニングに関する業務
3. モニタリングに関する業務
4. デビエーションに関する業務
5. 実施部門等からのチャレンジ/エスカレーションに関する業務
6. 各種プロモーション資材の審査業務
7. 講演会等スライドのレビュー業務
8. 審査/レビューの事前相談/お問合せ対応業務
9. 審査・監督委員会/Scientific Advisory Board/むつき会等の事務局業務

Role details:

1. 製薬協コードに準拠したアッヴィ自社コードの策定ならびに改定
2. プロモーション活動に関わる各種コード/ルール等に関する教育/トレーニングの企画・実施
3. 継続的な活動モニタリングを通じたリスク分析と対応策の検討
4. デビエーションに関する対応（VVR含む）
5. 実施部門等からのチャレンジ/エスカレーションへの対応
6. 講演会スライドレビューにおけるレビュー基準の整備とレビューコメントの一貫性の担保
7. 審査の基準・プロセスの適切な見直しとコマーシャル部門への周知・徹底
8. 審査の事前相談やお問合せの対応
9. 審査・監督委員会やScientific Advisory Boardの機能的な運営サポート
10. むつき会を通じた他社情報の収集

資格

Required competencies and experience:

1. Practical experience in supervisory department work or material review work in the pharmaceutical industry (3 years or more)
2. In-depth knowledge and understanding of relevant laws, industry norms, internal rules, etc.
3. University graduate or above (pharmacy, medical recommendation)
4. People with experience on the Pharmaceutical Cooperative Committee, etc. (preferred)

Education and training:

1. Bachelor’s degree or above (recommended for pharmacy, medicine, law, etc.

Required competencies and experience:

1. 製薬業界における監督部門業務あるいは資材審査業務の実務経験（3年以上）
2. 関連法規、業界規範、社内ルール等への深い知識と理解
3. 大卒以上（薬学、医学　推奨）
4. 製薬協委員等の経験者（尚可）

Education and qualifications:

1. 大卒以上（薬学、医学、法学等　推奨）

その他の情報

アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。