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Consultant, PAREXEL Consulting / eCTD申請におけるパブリッシング(eCTDの作成・編纂業務)業務担当者

Tokyo, Tokyo, Japan Date posted 02/12/2020 Job ID 58989BR

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。

主な業務は、PMDAeCTD要件に則りwordPDFファイルの加工やチェック(品質管理)を実施し、弊社のeCTD編集システムを使い、各リーフファイルのeCTD構造への割り付け、文書間リンクの作成、パブリッシュ(eCTDパッケージ作成)などを行う業務です。その他、薬事申請資料・承認審査関連資料の編集やフォーマッティング等の業務全般です。日本のプロジェクトチームのメンバーとして業務を行う他、海外のeCTDパブリッシングチームとの共同作業やプロジェクト管理等の機会もあります。

- Publisher in PC Japan who will work on JNDA/e-CTD Module 1 and 2.
- Project management of Publishing
- Publishing task with clients' publishing system

Qualifications

-実際にeCTD編纂システムを使用したeCTD編纂業務の経験
-CTD作成サポート経験(Authoring経験はなお可)
-パソコンスキル(PDF・エクセル・ワード・パワーポイント)
-英語(読み、書き、話せれば、なお可)


- Experience with publishing software (document and sequence level publishing) and DMS structure.
- Current knowledge of global regulatory standards, registration requirements and approval.
- Proficiency with use of PDF Plugins
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support, manage and prioritize multiple projects.
Proficiency with Microsoft Office.
- Excellent verbal and written communication skills.

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