求人ID : labo-375692579

【正社員】Global Labeling Lead

会社名非公開

リーダー , メンバー
1100万円~1350万円

募集要項

  • こだわり条件

    上場企業 従業員1000名以上 設立50年以上 土日祝日休み

  • 仕事内容

    ・Advises global internal stakeholders and business partners on best practices regarding planning and execution of labeling strategies.
    ・Responsible for leading the creation, implementation and maintenance of the Company Core Data Sheets applying scientific and clinical knowledge to the process.
    ・Manages labeling content review and approval process applying regulatory, therapeutic area and clinical knowledge to the process.
    ・Collaborates to assure labeling-relevant aspects of global and local regulatory strategies reflect best in class applications and programs meet all applicable regulatory and business requirements.
    ・Provide oversight to other Regulatory personnel including regional leads and ROW labeling implementation leads who are responsible for developing labeling/packaging or managing labeling content and ensure consistency across product
    labels.

  • 応募条件

    ・Working knowledge of FDA, EU, Japan, and China guidance, and labeling standards to business situations and medical and scientific content. 
    ・Demonstrated expert proficiency in managing and control of pharmaceutical labeling in accordance with local and global regulatory requirements. Direct pharmaceutical labeling development experience required with demonstrated proficiency in managing change control.
    ・Communication skills to establish positive relationships with the stakeholders and vendors
    ・Business level Japanese and English skills to comfortably work and communicate with colleagues in a global environment (TOEIC score 750 points or higher or equivalent)
    ・Proven effectiveness with stakeholders in the labeling system from content development through commercial supply.
    ・Previous experience working with US and ex-US labeling requirements, company core data sheet (CCDS) implementation and execution, and other regulatory requirements impacting or associated with labeling.
    ・Must be able to effectively influence peers both inside and outside the organization and maintain

  • 年収

    1100万円~1350万円
    【諸手当】Discretionary work allowance, Housing allowance, Commutation allowance, etc.
    【Salary Raise】Once a year
    【Bonus】Twice a year (July, December)

  • ポジション

    リーダー , メンバー

  • 雇用形態

    正社員

  • 勤務地

    東京都
    【最寄駅】
    ・JR山手線・京浜東北線・中央快速線の神田駅東口より徒歩15分
    ・JR総武快速線の新日本橋駅5番出口より徒歩5分
    ・東京メトロ鉄銀座線・半蔵門線の三越前駅A6出口より徒歩約3分

  • 勤務時間

    8:30~17:30
    【休憩時間】就業時間内1時間

  • 休日・休暇

    【Holidays】
    Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays

    【Vacation Leaves】
    Annual paid leave, childcare leave system, nursing care leave system, etc.

  • 福利厚生

    【保険】Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System,Property Accumulation Savings System

  • 勤務時間備考

    ※8:30~17:30(Mon~Thu)、8:30~15:45(Fri)、Flex-time system or Discretionary Work System

求人会社情報

  • 設立

    1939年3月

  • 資本金

    103,001,000,000円(2020年3月時点)

  • 従業員

    15,883名

  • 事業概要

    【業種】医薬品
    製薬会社

この求人の取り扱い人材紹介会社・コンサルタント ご相談や条件交渉などのサポートを行います

人材紹介会社情報

この求人に関連するスキルで検索



似ている求人を探す

求人検索をする

送信に失敗しました。

送信に失敗しました。