This is a contractor role untill End of Mar 2025 医薬品,医療機器等の品質,有効性及び安全性の確保等に関する法律(以下,薬機法) 及び関連法規に基 づく,医薬品,医薬部外品の薬事承認申請,⾏政対応,外国製造所との対応等の業務を,業務報告者の監督の下に行う 。 • 医薬品又は医薬部外品の薬事承認申請,届出 • 医薬品又は医薬部外品の変更管理業務(適切なRegulatory Assessmentの実施) • 外部講習会及び関連学会への参加等による薬事•業界知識の向上及び部内への伝達•理系大卒以上 • 5 年以上の CMC 薬事の経験。若しくは CMC 研究または生産部門で 5 年以上の業務経験と, CMC 申請資料作成の経験があり,薬事業務に興味と意欲がある。 •海外カウンターパート及び国内関係部門と連携して業務を遂行する調整能力がある。 •複数の製品の次々に発生する変更事項について,複数の国の変更申請を確実に履行するための,整理•計画•実行能力がある。 •業務上必要な英語の読み書きと会話ができ,さらに上達意欲がある。 (
Job Description [Position/ ポジション名] 渉外本部 Public Affairs Manager or Assistant Manager [Responsibilities/ 職務内容] Public Affairs Manager/Assistant Manager implements the business strategy, engagement, and activation of external stakeholders who drive or influence the policies that determine our ability to
Work Flexibility: Hybrid The Jobs Mission Under minimum supervision by Manager and Lead Specialist, he/she understands the laws and regulations, and efficiently conducts the duties such approval applications, notifications and other related tasks. マネジャー、リードスペシャリストの最小の指導の下、薬機法全般に精通し、豊富な知識と経験を有し、円滑な薬事申請及び関連業務の遂行を目的とする。 Key Activities
Job Description [Position/ ポジション名] 渉外本部 Public Affairs Manager [Responsibilities/ 職務内容] Public Affairs Manager implements the business strategy, engagement, and activation of external stakeholders who drive or influence the policies that determine our ability to successfully secure patient’s access
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
Job Description Summary ・Develop the medical expert engagement plan(s) in assigned therapeutic area(s) and local areas under the direction and agreement of the Group manager. Job Description Develop the medical expert engagement plan(s) in assigned therapeutic area(s) and
Job Description Summary Role Purpose: The Lead, TA Medical or Associate, TA Medical is accountable for building responsible brand or disease area medical strategy and ensuring its execution in collaboration with MSLs, MSEs and other partners with support from
Job Description Summary Develop the medical expert engagement plan(s) in assigned therapeutic area(s) and local areas under the direction and agreement of the Group manager. Job Description Develop the medical expert engagement plan(s) in assigned therapeutic area(s) and
Are you passionate about advancing Microsofts policy agenda and aligning it with the countrys interests? Do you have extensive experience and networks in government, policy, law, communications and/or corporate affairs? Do you want to work for a
Title: Medical Advisor / Medical Scientific Liaison FOP Company: IPSEN K.K. Job Description: As part of the Medical Affairs department, the MA/MSL is a hybrid, field-based scientific expert to external and internal stakeholders delivering non-promotional information exchange, supporting data and
Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive
■ 職務内容 / Job Description Drive development and execution of external communications strategy to drive a corporate reputation and advance science and therapeutic area leadership of AZKK. Leads a team of external communication managers and specialists
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
Title: Regulatory Affairs Manager Company: IPSEN K.K. Job Description: Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health
Responsibility: Co-develop global medical strategy to cater local unmet medical needs Support local EE network development and transfer of relationship ownership to Vaccine and Infectious Disease team Deep capabilities of MSLs to have a meaningful exchange with their
This is what you will do: The Medical Affairs Associate Medical Lead prepares a medical plan, which serves as the basis of medical activities of Alexion Pharma GK (AP-J) as a whole, and carries it out in cooperation with MSL and
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health
Are you interested in improving the lives of millions of people, contributing to a company that works with innovation and is a pioneer in addressing the unmet medical needs? Do you have an innovative mindset to drive
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Title: Clinical Affairs Specialist III, in vitro diagnostics (IVD) At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join
- Work closely with the Medical Affairs team to formulate and execute strategic medical activities in alignment with business objectives. This includes evidence generation, publication, and new product development. - Report directly to the head of medical affairs in Japan 企業情報
