職務内容： 以下の業務をRegulatory Expertと共に業務を行います。 ・DMF新規、変更及び維持管理（原薬及び添加剤等）と製販への連絡 ・外国製造業者認定の代理人としての業務 ・体外診断用医薬品/医療機器 承認申請維持管理 ・申請書内容と製造実態との定期的点検 ・PMDA相談 ・GMP適合性調査対応 ・輸入確認（薬監証明） ・法改正動向確認及びグローバル薬事への展開 応募要件： ・薬剤師免許取得 ・日常的な英文メールのやりとりに拒否反応が無いこと。 ・他部署と積極的にコミュニケーションが取れること。 ・医療業界で、薬事申請、品質保証又はCMC経験がある方は歓迎します。...
This is what you will do: This position, Head of Medical Affairs Rare Bone & Endocrine Disorders, Rare Tumours will provide strategic leadership to Alexion’s assigned therapeutic area portfolio, including in-line and pipeline assets. Responsible for providing
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director, Global Medical Communications - Japan to join our Medical Affairs team, supporting
Principal Responsibilities Contribute to the TA strategy through researching the medical environment, identifying and building relationships with KEEs, and through the planning, preparation of advisory board meetings. Participate in program meetings to stay updated on the
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
Pricing Manager Are you ready to shape how millions of patients in Japan access breakthrough treatments in obesity and cardiovascular care? This is a rare moment to join a market access team just as two of
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
Job Purpose The Clinical Scientist (CS) in Japan is responsible and accountable for clinical scientific outputs for assigned projects and studies in Japan. The CS will have accountability for approximately 2 - 4 projects (assets) at
Position summary Provide leadership and oversight as the Quality Assurance Responsible Person mandated by the Pharmaceuticals and Medical Devices Act, ensuring continued compliance with regulatory requirements and the maintenance of the companys pharmaceutical business license. Key accountabilities
Company Description Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant® is transforming patient care and accelerating new cancer therapies
Role Summary The Oncology Medical Science Liaison (MSL) is a field-based, non-promotional role supporting GSK’s clinical development activities in oncology in Japan. This position is focused on supporting ongoing and planned clinical trials through high-quality scientific
主な職務内容Key Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: ●Shape medical strategies that advance patient outcomes and strengthen GSK’s leadership in
Job title: PMS Planning and Management Specialist • Location: Tokyo, Japan - About the job As a PMS Planning and Management Specialist within our Regulatory Affairs team, youll help ensure the safety and integrity of new medicines by
Job Title: PMS Planning and Management Head • Location: Tokyo, Japan - About the Job As PMS Planning and Management Head within our Regulatory Affairs & Patient Safety team, youll lead a high-performing group responsible for shaping post-marketing
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Basic Purpose of the Job The Clinical Program Leader assumes Clinical Development responsibilities supporting early or late development projects, reporting to the Associate Global Head or the Global Clinical Programme Team Leader. The Clinical Program Leader