About Johnson & Johnson 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,
About Johnson & Johnson 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,
About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter
About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter
Description Who We Are At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, were the house of iconic brands - including Dr.Ci:Labo®, NEUTROGENA®, AVEENO®,
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
JOB SUMMARY: Briefly state the objective of this position. JCS supports Japan Clinical Lead (JCL) activities in the development and execution of clinical development strategy for target indication(s) in assigned compound(s) to obtain regulatory approval in Japan.
About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter
As a Manager in Market Access & Marketing, you will oversee insurance applications, regulatory submissions, and launch strategies for advanced cancer diagnostics. You will also lead a marketing team and drive commercial success for the Oncomine Dx Target
The Japan Safety Pharmacovigilance Associate ensures compliance with local safety regulations and executes pharmacovigilance processes. The role involves collaborating with cross-functional teams and regulatory authorities to manage safety data effectively. Client Details The client is a leading
Take lead in RA activities to obtain product approval. Ensure effective submission requirements as well proper timelines of new/existing regulatory projects. Client Details * One of the top global pharmaceutical companies in the industry * Specializing in oncology,
Take lead in RA activities to obtain product approval. Ensure effective submission requirements as well proper timelines of new/existing regulatory projects. Client Details * One of the top global pharmaceutical companies in the industry * Specializing in oncology,
JOB DESCRIPTION: 職務記述書 募集用 RA Senior Specialist, Grade 14～15 体外診断用医薬品及び医療機器の新規申請品目の薬事申請、保険適用に関する戦略を関連部門と協議の上策定する。 担当事業部製品に対し、MKTG、R/Dと薬事申請、保険適用のプランを部門長と共に行う。 プランに従い、新規製品の薬事申請、保険適用及び必要な社内の手続きを行う。 製品の変更連絡を評価し、返答を実施する。該当する場合、必要な薬事上の手続きを行う。 広告、顧客レター等のタイムリーなレビューを行う。 薬事部メンバー及び他のプロジェクトチームメンバー等に薬事申請、薬事規制、法規制等についてトレーニング を行う。 業界団体（臨薬協、AMDD等）の活動に参加し、当社のコンプライアンスポジションを優位な状態に維持すると 共に、業界の発展に寄与する。 担当事業部関連業務の進捗状況を上長へ報告する。申請戦略やコンプライアンス戦略、その他薬事上の決定でリーダーシップを取る責任がある。 厚生労働省、PMDA、都道府県庁及び他社と薬事上の問題についての解決案を策定し、上長に適切な進言し、また必要に応じて直接交渉を行う責任がある。 薬事規制とビジネスとのバランスを取りつつ、コンプライアンスを遵守する方策を考え、上長へ進言をする。その他、上長より指示された業務を遂行する。 TOEIC:600点以上 海外製造所との電話会議の実施が必要。 •Develop strategies for new IVD applications and reimbursement coverage. •Conduct IVD submission applications, reimbursement
Work ScheduleStandard (Mon-Fri) Environmental ConditionsOffice Job Description Job Posting Title : Program Manager Hiring Legal Entity : Life Technologies Japan Ltd. Division :CSD Job Band : 6 *Manager role is expected for Band 6 or
About Johnson & Johnson 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,
Study Start Up Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission
【応募要件】 臨床試験の経験は必須、企業経験（3-5年以上）があり開発経験があるMD（日本医師免許）保持者限定 経験によりClinical Science LeadもしくはSr. Clinical Scientistでの採用となる可能性あり Assume overall responsibilities as a regional/country level Development Team leader in the matrix setting to ensure alignment across key stakeholders and promote team work. Drive the development of Clinical
Obtaining and maintaining regulatory approvals from the Ministry of Health, Labour and Welfare to market ophthalmology-specific medical devices, pharmaceuticals and quasi-drugs in Japan. [Strengths] The role will provide a wide range of knowledge and experience in regulatory affairs,
Job Description SummaryTo manage business and operational activities of local regulatory writing (RW) to ensure timely production of high quality clinical documentation. To ensure compliance with global RW strategy and implementation of technical activities & strategies according
Responsibilities:• Under general direction, leads/coordinates Quality Assurance activities in accordance with cGMP standards• Ensures compliance with established internal specifications, standard operating procedures (SOP) and government regulations• Coordinates and manages complex deviations, task forces and communication to
