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Consultant, PAREXEL Consulting / 新薬開発計画に関わるCMCパートのコンサルタント

Tokyo, Tokyo, Japan Date posted 09/11/2019 Job ID 54736BR

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.

  • Full Time
  • Level: Mid
  • Travel: Yes
  • Glassdoor Rating 3.5

Success Profile

Check out the top traits we're looking for and see if you have the right mix.

  • Detail-Oriented
  • Proactive
  • Problem-Solver
  • Results-Driven
  • Organized
  • Multi-Tasker
  • "They say if you are passionate about what you do, you will never work a day in your life. I can honestly say that this applies to me. I love what I do."

    Jasen - Consultant
  • "My experience so far with Parexel has been great! I had initially started at Parexel as an Independent Consultant but was then presented with a full time job opportunity to really become a part of this fascinating company. I have enjoyed the flexibility to be able to orchestrate a good work/life balance, as well as learn from so many experts in consulting arena and really have a hands-on role with every day bringing a new but exciting challenge."

    Aqip – Consultant
  • "I was offered an incredible opportunity to continue my career in regulatory affairs without relocating 1,000 miles away and making major life changes. Parexel is an innovative, growing company which offers much needed flexibility and opportunities for professional growth."

    Blaine – Consultant
  • "Parexel is a very large organization and holds a top position amongst the different companies engaged in the Consulting business. It can offer many opportunities for development and career progression. Also the diversity of projects can offer a great expansion of knowledge in many areas of the Regulatory Affairs arena. Last (but not least), Parexel offers a variety of rewards to the employees (bonus scheme, benefits etc)."

    Giannis – Consultant
  • "Parexel is a CRO that I had always inspired to join because of the variety of knowledge, experts, culture, flexibility and exposure to be client facing as well as to use my technical knowledge all under a professional and diligent environment. I believe it has provided me the right platform to grow both professionally and individually with the opportunities to present my views and to dialogue with colleagues and clients with all but positive outcomes."

    Aqip – Consultant

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Management

    Strong management with depth of experience working for global health authorities.

Responsibilities

PAREXEL Consulting部では、海外で開発あるいは承認されている医薬品や医療機器を、いかに海外データを有効利用して日本における臨床開発、 申請から承認取得までを最低限の時間と経費で取得できるか、その承認申請にかかわる薬機法(各国の規制要件の分析)、行政の動向、や医学専門家との 協議をもとに新薬開発戦略(プロトコールの作成、治験相談、CTD作成サポートなど)を立案し、海外や国内の医薬品、 医療機器のクライアントへコンサルテーションを行っています。


職務内容:
  • プロジェクトリーダーの指示のもと、新薬開発段階での開発戦略及びCMC薬事戦略策定から製造販売承認申請及び承認取得後の製品の変更管理に関わるCMC薬事業務全般。また、クライントと協議、交渉を行う。
  • パレクセルの業務遂行手順を順守する。
  • クライアントに提出する成果物に、新たに習得した知識を効果的に反映させる。
業務内容
プロジェクトにアサインされた後、クライアントと協同して、下記のコンサルテーションやCMC関連の薬事申請資料を作成サポートします。
  • 薬剤開発における既存成績並びに情報の分析並びに評価
  • 日本での臨床開発計画及び薬事申請のためのCMC薬事戦略の策定。
  • 製造販売承認申請資料(新規申請、一変申請及び軽微変更届)の作成及び申請。
  • PMDA相談資料作成及び規制当局との照会事項対応。
  • 申請後の照会事項対応及びPMDAとの対応支援を行い、製造販売承認を取得。
  • 医薬品原薬等登録原簿(MF)及び外国製造業者認定(FMA)手続きの支援
  • GMP適合性調査サポート
  • カルタヘナ法に係る申請手続きの支援
  • 医薬品原薬等登録原簿の国内管理人業務(変更管理における薬事評価を含む)
  • 様々な薬事コンサルティング

Qualifications

技術的能力
  • 製薬会社における医薬品開発(もしくはCROでの勤務)におけるCMC薬事経験5年以上
  • 製造販売承認申請書作成、CTD作成、医薬品原薬等登録原簿の作成などの経験
  • 生物製剤に関するCMC経験者なら、尚可
  • 最終学歴: 大学卒(薬学もしくはその他の自然科学分野の専攻)
インターパーソナル能力
  • コミュニケーション能力
  • ロジカルシンキング
  • 英語での業務上のコミュニケーションが可能(スピーキング、ライティング)
    • コンサルタント> TOEIC 700(目安)

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