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[Innovative Medicine] Experienced Labeling Specialist, Labeling Group, License ＆ Operations, Regulatory Affairs
年収：800万 ～ 1300万
採用企業案件
特集求人
ヤンセンファーマ株式会社
-
- 会社規模501-5000人
- 医薬品メーカー
| 部署・役職名 | [Innovative Medicine] Experienced Labeling Specialist, Labeling Group, License ＆ Operations, Regulatory Affairs |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
■JOB SUMMARY Under the supervision of their supervisor: ・Develop Japanese package inserts (Japanese PI) based on Japanese target label ・Run Japan Labeling committee process to develop labeling positions for marketed product issues ・Collaborate with Global Labeling and/or CDT on creation/revision of Japanese PI proactively ・Maintain some Japanese PI in post-approval environment and negotiate Japanese labeling of Marketed products with HA ■KEY RESPONSIBILITIES ♢Development J-PI ・Participates in development of labeling negotiation Japanese strategies and development of supporting documentation for Japanese labeling ・Develop Japanese PI from Japanese Target Label ・Update Japanese PI based on updated CCDS and new data ・Interface with tracking function to ensure that changes are being tracked and advise on Japanese label audit ・Run the Japan Labeling Working Group process and participate in these groups ♢Labeling Committee ・Run Japan Labeling committee process to develop Japanese labeling positions for both development and marketed product issues ・Explain labeling position on proposed labeling at the Japan Labeling Committee ・Prepare final proposed Japanese PI for review by Labeling Working Group and Labeling Committee ♢Relationship with Global Team ・Serve as a support member of the global Labeling Working Group and provides input on proposed updates to the CCDS/USPI/SmPC ・Receive information on CCDS from Global Labeling and disseminate it to relevant people in JANSSEN JAPAN ・Communicate with Global Labeling and/or CDT on creation/revision of Japanese PI ・Share information with Global Labeling on US/EU/Japan labeling and act as a window to it ・Provide support in preparing responses to Call for Information in preparation of PSURs regarding Japanese input (Approval information: Indication, Dosage and Administration etc). ♢Post approval maintenance ・Maintain Japanese PI in post-approval environment ・Revise Japanese PI and provide input on implementation timelines as necessary ・Provide labeling support necessary to defend the company labeling position in Japan when issues arise ・Team with Japanese Labeling Therapeutic area representatives and collaborate with partners including Health Authorities, Manufacturing, Regulatory Operations, and Regulatory Affairs etc in Japan. ♢Interactions with HA ・Negotiate Japanese labeling of post-approval products with HA (ensure alignment with global strategy) as appropriate ・Review Japanese PI in preparation for meeting with Health Authorities ♢Print Labeling and others ・Execute the technical aspects of labeling process (e.g., partner with Japan Submission Operations to prepare labeling submissions, and with Graphic Services to develop artwork for implementation in packaging and website display) ・Prepare Japan unique explanatory documents called "Kaisetsusho" which explains rationale for "Precautions for Use" included in new drugs' J-PI. ・Ensure effective quality control of labels |
| 応募資格 |
【必須（MUST）】 ♢Experience/KnowledgeA minimum of 3 years of pharmaceutical industry experience (clinical development, safety, regulatory affaris) and/or experience associated with product labeling/labeling regulations is required. ♢Skills/Capabilities Good verbal and written communication skills in Japanese/ English is required. TOEIC score: over 700 ♢Qualification/Certificate A minimum of Bachelor degree in a scientific discipline, especially pharmaceutical science, is preferred. ♢Preferred Skills: Analytical Reasoning, Brand Research, Business Behavior, Design Thinking, Detail-Oriented, Industry Analysis, Market Research, Package and Labeling Regulations, Problem Solving, Process Oriented, Product Packaging Design, Project Management, Project Support, Proof Reading Software, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Risk Assessments, Safety-Oriented |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | その他 「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください |
| 更新日 | 2026/01/19 |
| 求人番号 | 6534521 |
採用企業情報
- ヤンセンファーマ株式会社
-
- 会社規模501-5000人
- 医薬品メーカー
-
会社概要
私たちヤンセンファーマは、世界最大級のトータル・ヘルスケア・カンパニー、
ジョンソン・エンド・ジョンソン（J＆J）グループの製薬会社として、いまだ
満たされていない医療ニーズに迅速に応え、最先端の医薬品を一刻も早く患者
さんの手元に届けることができるよう取り組んでいます。
私たちは、世界57ケ国200社以上に及ぶJ＆Jグループを貫く経営理念「我が信条
（Our Credo）」を志とし、さらに、46年間に84品目もの新薬を開発したヤンセ
ン・ファーマスーティカ社の創業者、ポール・ヤンセン博士の妥協なき開発精
神を継承し、J＆Jグループの優れた新薬の導入はもちろん、医療現場への適切
かつ最新の医療情報の提供、さらには、患者さんのＱＯＬ（クオリティ・オブ・
ライフ）の向上を目指した支援活動などをおこなっています。
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です