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求人ID : 1462835 更新日 : 2024年05月23日
IT x ライフサイエンス

Senior Lead, Global Compliance and Strategy, APAC (治験業務経験者)

採用企業 メディデータ・ソリューションズ株式会社
勤務地 東京都 23区, 千代田区
雇用形態 正社員
給与 1100万円 ~ 1500万円

ワークスタイル

リモートワーク・在宅勤務 服装カジュアル 副業OK フレックスタイム制

募集要項

Your Mission:

With Medidata’s continued growth in the Asia regions (including Japan, China, Korea, Singapore, and Australia), the ideal candidate will serve as a geographically local resource focusing on matters related to Medidata’s Quality Management System and regulatory strategy with a specific focus on the Japan market and region. Enable both internal and external stakeholders to progressively enhance Medidata’s value proposition through the adoption of emerging clinical trial technologies while successfully meeting and navigating global regulatory expectations. Reporting directly to the Director, Global Compliance and Strategy (“GCS”) APAC, the ideal candidate will:

  • ●        Engage with key local regulatory agencies in the Japan region (e.g. PMDA, JPMA) and government authorities if applicable to ensure that Medidata’s interest as a Software as a Service (SaaS) technology company serving regulated companies is considered in regulatory guidance documents and agency perceptions.

    ●        Interact directly with customers to address quality and regulatory related matters relevant to the use of technology in performing clinical trials.

    ●        Collaborate cross-functionally with other Medidata business units (e.g. Legal, Information Technology, Product Development, Sales, RFX) to contribute to achieving Medidata’s goals, business plan, and long-term strategy.

    ●        Grow Medidata’s Unified Protection Strategy in collaboration with Information Security, Data Privacy and Cloud Operations and work closely with the Quality/Customer Management and Regulatory functions within GCS.

    ●        Collaborate with GCS peers in the performance and delivery of day-to-day activities of the GCS organization.

    ●        Balance multiple priorities, workload, and complete assignments to ensure the team achieves overall customer focused mission and objectives.

    ●        Fulfill the responsibilities for providing operational support to GCS-managed programs (e.g. quality incident management, internal quality system audits, customer audit/inspection needs).

応募必要条件

職務経験 10年以上
キャリアレベル 中途経験者レベル
英語レベル ビジネス会話レベル (英語使用比率: 50%程度)
日本語レベル ネイティブ
最終学歴 大学卒: 学士号
現在のビザ 日本での就労許可が必要です

スキル・資格

Your Competencies:

  • ●     Strong understanding of regulations governing clinical trials, including:

    ●     Framework guidelines including ICH Good Clinical Practices (GCP) and regional distinctions.

    ●     Clinical Regulations (e.g. JGCP, specific requirements in Japan on Clinical trials, and PMDA inspections).

    ●     Regulations on data management in clinical trials.

    ●     Computer Systems Validation.

    ●     Extensive experience in clinical trial processes and technologies, including, but not limited to a strong working knowledge of trial master file and site master files (TMF/SMF) and eTMF.

    ●     Understands quality systems processes and enablement including auditing, root cause analysis and CAPA development.

    ●     PMDA inspection experience is preferred.

    ●     Proven track record of working independently to evaluate requirements and propose solutions.

    ●     Strong teamwork spirit and good communication skills.

    ●     Fluent (read, write, speak) in English and Japanese.

    ●     Based in Medidata’s Tokyo office.

 

Your Education & Experience:

  • ●        Bachelor's degree required with 8 years of experience, 5 years of experience with a Master’s; or equivalent years of experience in the life sciences industry and/or medical/clinical operations.

    ●        Requires a minimum of 2 to 3 years of experience in clinical trial processes and technologies, including a strong working knowledge of Quality Management Systems enablement.

    ●        Strong understanding of regulations governing clinical trials including Clinical Regulations and Framework guidelines including ICH Good Clinical Practices (GCP).

    ●        Demonstrated experience as a compliance functional expert (especially with regards to clinical processes and technologies) with proven ability to present to corporate executives.

    ●        Inspection management experience is a strong plus.

    ●        Ability to travel expected at approximately 10%.

    ●        Able to work independently.

    ●        Prior experience with a large central IRB or Ethics Committee is preferred.

勤務地

  • 東京都 23区, 千代田区
  • 山手線駅

労働条件

雇用形態 正社員
給与 1100万円 ~ 1500万円
勤務時間 Super Flex
休日・休暇 Weekends, Japanese Public Holidays, Company Holidays
配属部署 Global Compliance and Strategy
業種 ソフトウエア

職種

  • 技術・専門職系(メディカル) > 薬事・学術
  • 技術・専門職系(メディカル) > 生産管理・品質管理・品質保証・工場長(メディカル)
  • 技術・専門職系(メディカル) > 臨床開発、治験、CRA・CRC
  • 技術・専門職系(メディカル) > 研究・開発(医薬品)
  • 技術・専門職系(メディカル) > プロジェクトマネージャー(メディカル)

会社概要

会社の種類 外資系企業
外国人の割合 外国人 半数