- 常勤
- 東京都
【東京都品川区】外資系大手製薬メーカーMA
メディカルアフェアーズグループマネージャーorメディカルアドバイザー/グループマネージャーorノンラインマネージャー /医薬開発本部クリニカルディベロップメント・メディカルアフェアーズ心・腎・代謝領域
- 300422296
- 2026年02月16日更新
- 当直なし
- オンコールなし
| 勤務地 | 東京都品川区 |
|---|---|
| 給与（年収） | 1000万円 応相談 |
| 募集科目 | 一般内科、循環器内科、内分泌内科、糖尿病内科、腎臓内科、その他、製薬会社 |
| 交通アクセス | *** |
| 医療機関区分 | その他会社 |
| 病床数 | ・・・ |
| 屋内の受動喫煙対策 | 敷地内禁煙 |
求人情報
勤務内容・条件
| 募集科目 | 一般内科、循環器内科、内分泌内科、糖尿病内科、腎臓内科、その他、製薬会社 |
|---|---|
| 勤務内容 | その他 対象専門科目：内科、循環器内科、糖尿病内分泌科、腎臓内科 仕事内容： Basic purpose of the job To contribute to execute CDMA (Clinical Development & Medical Affairs) activities in Japan according to TA (Therapeutic Area) strategy between start of preclinical development and late stages of commercialization. Accountabilities ・Strengthen the profile of our products by providing medical/scientific robust guidance in the responsible therapeutic area through the total process of the clinical development phases, in collaboration with Global and other departments. ・Ensure and support Japanese submission and registrations in the respective products collaborating with regulatory/ clinical development team. (Support the clinical part until approval, such as preparation of responses to PMDA queries.) ・Responsible for making Japanese clinical development plan recognized by global Medicine as well aligned with global development strategy in the respective therapeutic area. ・Support our company make development/data building decision based on total picture (all projects/trials in the respects of resource/budget) in the therapeutic area. ・Contribution to CDPs (Clinical Data Packages) after proof of concept and late stages of commercialization. ・Prepare Integrated Customer Plan to address Japan specific needs, together with Marketing and Market Access & aligned with global IAP (Integrated Asset Plan). ・Build new scientific evidence by collaboration with external experts through clinical/pre-clinical researches, investigator initiated studies and RWE (Real World Evidence) studies. ・Contribution to benefit/risk evaluations of products. ・Gain insight from external expert with MSL (Medical Science Liaison) and propose medical strategy. Regulatory and / or Organizational Requirements Contribute to Strategy and Activity Review Committee meetings. Ensure ethics and compliance. Ensure re-examination by reviewing documents and process. Plan strategically to allow for effective, safe & medically sound global preparation of drug commercialization efforts. Provide input and medical review of all internal and external documentation prepared by Marketing and Public Relations. Define trials needed to answer relevant questions regarding our products and their related development projects to meet regulatory and payer requirements and our commercial needs build upon from the trial’s concepts developed by the Medical subteam and local project team for registration. Provide medical input into epidemiology studies. Ensure communication with CPL (Clinical Project Leader). Support obtaining preferable pricing. Job Complexity ・Works in a cross-functional team including MSL, CPL, RA (Regulatory Affairs), PSPV (Patient Safety & Pharmacovigilance), BDS (Biostatistics & Data Sciences), Marketing, and Market Access ・Requires driving cross-functional projects. People management responsibilities may be assigned depending on the candidate’s career background and organizational needs. ・Plays a key role in planning and leading medical education initiatives in collaboration with internal and external stakeholders. |
| 週勤務日数 | 5.0日 |
| 勤務時間 | (月～金) 09時00分 ～ 17時30分 週5日（月～金曜日） 9：00-17：30 （休憩時間60分） フレックスタイム制（コアタイム無） |
| 当直 | なし |
待遇・手当
| 給与（年俸） | 1000万円 応相談 |
|---|---|
| 赴任手当 | - |
| 住宅手当 | - |
| 宿舎の提供 | - |
| 自動車通勤 | - |
福利厚生
| 休日 | 日曜日、祝日、土曜日 |
|---|---|
| 休暇 | 年末年始、その他休暇、初年度有給休暇 |
| 研究日 | なし |
| 社会保険 | 健康保険、雇用保険、労災保険、厚生年金 |
| 学会出席 | - |
その他
| 試用期間 | あり（6カ月）同条件 |
|---|---|
| 備考 | ・勤務地：東京都品川区 ・年収1000万円～（目安）※経験・スキルによります。 ・時間外労働：あり ・加入保険 社会保険：健康保険、厚生年金保険 労働保険：雇用保険、労働者災害補償保険 【必須条件】 ・生命科学分野の修士号 ・臨床または研究環境におけるTA経験（腎臓学、心臓病学、内分泌学分野が望ましい） ・ビジネスレベルの英語力（TOEIC800以上） 【歓迎スキル】 ・医師免許保有者 ・PhD保有 ・PMDA相談、新薬承認申請（NDA）、製品発売に関連する臨床開発・規制当局対応の経験があれば尚可 ・研究プロジェクトの構想立案、基礎・臨床研究の独立実施、学術論文執筆能力 |
