社名
社名非公開
職種
薬事、メディカルライティング
業務内容
オンコロジーに強み持つ日本立ち上げ段階の企業の募集です
多くのパイプラインを有しており、今後が期待される企業です
少数精鋭の組織のため経験者を歓迎しております
求められる経験
• BA/BS Degree in sceintific disciplines, MS/PhD preferred
• 3+ years of related pharmaceutical or pharmaceutical industry regulatory CMC experience with proven record of experience in global submissions for clinical trial/market applications and subsequent response to HA queries.
...
• Experiences to prepare CTD M2.3 and M1.2 (Application Form).
• Experiences to respond against inquiries from PMDA.
• In-depth knowledge of ICH requirements, US/EU/JP regulatory and requirements.
• Knowledge/experience with rest of world regions and GMP regulation and post-approval submissions is a plus.
• Experience in authoring complex technical documents and regulatory CTD (M2 and M3) sections.
• Educational background in scientific disciplines and expertise in at least one area in pharmaceutical development (chemical process, formulation, manufacturing, QC, QA, etc).
• Excellent oral and written communications skills are a must-have.
• The candidate should be detail-oriented, a self-motivated, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment
保険
健康保険 厚生年金保険 雇用保険
休日休暇
土曜日 日曜日 祝日
給与
年収1,000 ~ 1,500万円
賞与
-
雇用期間
期間の定めなし
show more
社名
社名非公開
職種
薬事、メディカルライティング
業務内容
オンコロジーに強み持つ日本立ち上げ段階の企業の募集です
多くのパイプラインを有しており、今後が期待される企業です
少数精鋭の組織のため経験者を歓迎しております
求められる経験
• BA/BS Degree in sceintific disciplines, MS/PhD preferred
• 3+ years of related pharmaceutical or pharmaceutical industry regulatory CMC experience with proven record of experience in global submissions for clinical trial/market applications and subsequent response to HA queries.
• Experiences to prepare CTD M2.3 and M1.2 (Application Form).
• Experiences to respond against inquiries from PMDA.
• In-depth knowledge of ICH requirements, US/EU/JP regulatory and requirements.
• Knowledge/experience with rest of world regions and GMP regulation and post-approval submissions is a plus.
• Experience in authoring complex technical documents and regulatory CTD (M2 and M3) sections.
• Educational background in scientific disciplines and expertise in at least one area in pharmaceutical development (chemical process, formulation, manufacturing, QC, QA, etc).
• Excellent oral and written communications skills are a must-have.
• The candidate should be detail-oriented, a self-motivated, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment
...
保険
健康保険 厚生年金保険 雇用保険
休日休暇
土曜日 日曜日 祝日
給与
年収1,000 ~ 1,500万円
賞与
-
雇用期間
期間の定めなし
show more