Chūō 第一三共株式会社
ADC変更管理担当

募集要項

・ADC品目の市販後CMC変更管理に対する、

1.製造所等から提案される変更案件のリスト化、および薬事評価要否検討

2.上記の薬事評価要否検討結果に対する関係部所との協議、合意形成

3.各変更が最終的に紐づく製剤ロット、および市場出荷時期の可視化

4.各変更の承認希望時期の設定、および関係部所への情報提供

5.変更案件の薬事対応ステータス、および影響を受ける製剤ロットの確認

必要な経験・スキル

<必須>

・製薬企業でのQA、RA、CMO管理等の業務において、市販後CMC変更管理に関わる業務経験

・英語でのメール、会議が可能な英語力(目安としてTOEIC 730点以上 もしくは、それに相当する英語力)

<望ましい>

・抗体、ADCに関する知識と業務経験

資格・身分

<必須>

・大学卒業以上の方

<望ましい>

-

給与

経験・能力を考慮し、当社規定により算出します。

昇給・賞与

昇給:年1回 賞与:年2回(7月、12月)

福利厚生

各種社会保険、社宅制度、財産形成支援制度、自己啓発支援 等

休暇

年次有給休暇、リフレッシュ休暇、育児休業制度、介護休業制度、ボランティア休暇 等

諸手当

住宅手当、通勤手当、出張・外勤手当、時間外労働手当等

休日

毎週土曜日・日曜日、祝日、会社設定休日(GW・夏季・年末年始)等

勤務地

東京(日本橋・本社) ※第一三共グループは2020年4月より敷地内全面禁煙です。また標準就業時間帯は、事業場内外を問わず禁煙となります。

募集人数

若干名

備考

入社時期:応相談

※エントリー時に学歴・職務経歴書をアップロードする必要がありますので、あらかじめご用意ください。

○学歴・職務経歴書について

・書式は自由です。

・高校からの学歴・職務経歴を記載ください。

・右上に顔写真の貼付をお願いいたします。

・推奨ファイル形式はPDFです。

Word,Excel,PowerPointもご利用いただけますが

使用するPC環境によりレイアウトが変わる可能性がありますので、

PDFファイルのアップロードをお勧めいたします。

上記4つ以外のファイル形式はアップロードできませんのでご注意ください。

・アップロードできるファイルサイズは最大2MBまでとなります。
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