Labeling Manager

Job Details

Responsible for preparation and revision of package insert in timely manner for appropriate use of the company’s products

<Responsibilities>
1. Control, manage and educate team members for target clearance and improve quality of works in the group
2. Satisfy CCDS submission compliance in the group
3. Control group resources (budget, time and information) effectively
4. Prepare new package insert and revise current package insert in timely manner and appropriately as which they can result in the appropriate use of the product
5. Make closer communication with global labeling team (strategic global labeling) on new labeling preparation, labeling change and improve quality of labeling
6. Sufficient training for sales people, customer support and other concerned people on labeling change with enough and higher quality training materials in the expected time line
7. Collect domestic and international updated regulatory information and knowledge on labeling and co-use with people concerned and prepare for newly coming labeling requirement
8. Maintain relevant local SOPs and work instructions for efficient work

<応募要件>

・Strong proven leadership
・Ability and desire to create results
・Ability to effectively work under tight deadlines and manage projects independently
・Resourcefulness in solving problem
・Cutting-edge regulatory knowledge including PI
・Knowledge about global PI trend, mainly US and EMA
・Requires excellent written and verbal communications (both in English and Japanese)
・Excellent people skills and an upbeat and enthusiastic attitude
・At least 3 year labeling activities
・5 year regulatory, clinical development, or GVP related activities preferred
・Bachelor’s degree, ideally science area, such as pharmacy, biochemistry

※グローバルに展開する研究開発型のバイオ医薬品企業です。こちらの企業では、様々な福利厚生プログラムが用意されている他、異なるライフステージにいる社員一人ひとりがベストのパフォーマンスを出せるよう、主体的なワークライフマネジメントをサポートする制度も整えられています。

Job application

Apex delivers strong profile and highly skilled candidates that match the job description requirements. Their candidate know how, network and experience helped us to initiate contact and integrate the candidate into our company. We are very happy with the candidate selected by Apex. K.K. consulting service. Thank you for the professional recruitment consulting service throughout the selection and follow up. We really appreciated it and strongly recommend Apex.

APAC Head of Supply Chain

Global Healthcare Company