職務の目的
開発品目の承認申請時の添付文書案作成等:
市販品目の添付文書管理:
アートワーク管理:
市販後薬事:
主な業務内容
必要な条件
望ましい条件
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
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Minato MedtronicJOB TITLE: RA Specialist · DEPARTMENT:QA-RA CV/DIB portfolio CRM · REPORTING TO:RA Director · ********************************************************************************************** · Main Mission of Job · "Being a "bridge" to deliver "meaningful" medical device to Ja ...
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Minato 711 GlaxoSmithKline K.K. Full time職務の目的 · 開発品目の承認申請時の添付文書案作成等: · 薬事規制及びGSKポリシーに従い、申請内容に基づく添付文書案作成においてプロジェクトチームをリードする。 · CCDSに基づく添付文書の記載事項が承認されるよう、承認審査における添付文書関連照会事項に対する回答作成をリードする。 · 市販品目の添付文書管理: · 薬事規制及びGSKポリシーに従い、最新の情報に基づく添付文書の改訂及び改訂添付文書の公開を滞りなく行う。 · 添付文書に係るカスタマーからの問い合わせに対して適切に回答する。 · アートワーク管理: · 必要な薬事Inputを行い、 ...
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Minato Baxter Full timeThis is where you save and sustain lives · At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves out ...
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Minato Goldman SachsCompliance, Regulatory Practice Group, Vice President (Tokyo) · Responsibilities · The RPG team for Tokyo coordinates, on behalf of Goldman Sachs, responses to requests for information received by the firm from Japanese regulators. The team also periodically responds to request ...
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Minato 711 GlaxoSmithKline K.K. Full timeJob Purpose: · The CPMS Asia/Japan Lead will provide technical therapeutic, and product development support for GlaxoSmithKline projects. Individuals will ensure the optimal application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and will have a proficiency in practi ...
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MSL(Oncology)
2日前
Minato 711 GlaxoSmithKline K.K. Full timeJob purpose · Medical Science Liaison (MSL) is a field-based role in the new Medical and Development organization, reporting to MSL Head. · In order to build a trust with External Experts (EE) and scientific community through, MSL needs to play a role as external facing function ...