Apr 07, 2022

Job Description

For both biosimilar products and small molecules products, conducting and reporting clinical trials using CROs,preparation of submission dossier documents (CTD M2, M4, M5), interaction with PMDA during pre-submission and review period, and acquisition of approvals on schedule.

Your Responsibilities:
Review and evaluate clinical data
 Plan clinical development strategy with assistance from GM (Group manager) and global team
 Prepare documents for PMDA consultation in collaboration with global team
 Learn relevant therapeutic area for biosimilar products
 Execute and report (mainly management of the CRO) bioequivalence studies and pharmacodynamic studies
in accordance with GCP and other regulatory requirements with assistance from GM
 Prepare submission dossier and response to PMDA inquiries (English draft is prepared by the Global team)
about non-clinical and clinical part with assistance from GM and global team
 Archive relevant documents
 Support marketing team after getting approval
 Budget control and vender Management
 Submit CDISC standard compliant data for biosimilars to PMDA. (You may use the help of an outside expert)
 For the non-clinical part (*), it is a plus if you have the ability to review the eligibility of the materials created
by the Global team or the non-clinical Expert of the affiliated company as the approval application materials
in Japan. (*: Pharmacological studies, pharmacokinetic studies, toxicity studies of M4 and M5 of CTD)

 臨床データをレビューおよび評価する
 Group managerとグローバルチームの⽀援を受けて臨床開発戦略を計画する
 グローバルチームと協⼒してPMDAの対⾯助⾔に必要な資料を準備する
 担当するバイオシミラー製品の治療領域に必要な知識を習得する
 Group managerの⽀援を受けて、CROを利⽤し、GCP及びその他規制要件に準拠した⽣物学的同等性試験及び薬⼒学的試験の実施および報告(委託先CROのマネジメントが主となる)を⾏う
 Group managerおよびグローバルチームの⽀援を受けて、申請資料及び照会事項回答の⾮臨床・臨床パートを準備する。(英語原案はGlobalにて作成)
 関連ドキュメントをアーカイブする
 承認を得た後、マーケティングチームをサポートする
 予算とベンダー(CRO)の管理をする
 バイオシミラーのCDISC標準準拠データの提出を⾏う。(外部識者の助けを借りてよい)
 ⾮臨床部分(*)について, Global team⼜は提携会社の⾮臨床Expertが作成した資料について、⽇本での承認申請資料としての適格性をレビューするレベルの能⼒があれば尚可。(*:CTDのModule 4及びModule 5の薬理試験,薬物動態試験,毒性試験)

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

What you will bring to the role:
More than 5 years experiences of clinical studies in Japan. Experience of multinational
trials is preferable.
 Experience in biosimilar project is preferable
 Experience of project management is also preferable.
 Understanding of GCP and other related Japanese guidelines
Bachelor degree in pharmaceutical science, biochemistry or Master degree is
preferable. Veterinary science is also acceptable

Languages: Fluent Japanese and business level of English

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Sandoz!
Commercial OPS SIR SZ
Research & Development
Full Time
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