社名
社名非公開
職種
薬事、メディカルライティング
業務内容
...
Responsible for planning and executing medical activities and make sure timely and effective execution aligned to medical strategy. Reporting to TA Medical head1. Key accountabilities1-1. Lead Medical Strategy■ Lead and monitor the execution of the Japan Medical Plan to ensure on-time and on-budget delivery of all tactical activities or deliverables■ Provide medical and technical input into medically accurate development of Brand promotional materials in close alignment with marketing team and communicate the details and progress of the Medical Plan to local Medical Team, the Global Medical and all parties responsible for execution■ Work with cross-functional, multidisciplinary teams to facilitate the creation of medical strategies about products to answer unsolicited medical requests from internal and external stakeholders and ensure strategic and cross-functional alignment across the organization and any joint ventures to achieve the medical mission of supporting safe and appropriate use of a particular brand(s)/ projects■ Leverage (unmet) medical needs in order to support lifecycle opportunities based on patient needs on a rolling basis through the development cycle1-2. Evidence generation■ Liaise with key internal stakeholders to help develop, secure approval for and implement independent post approval studies that have the potential to support our company products. Review, approve and supervise all aspects of clinical study programs, including preparation of study protocols, case report forms, study reports, statistical analysis plans, clinical trial guidelines and the accurate and timely reporting of study data■ Oversee conduct of all clinical studies in adherence to both Company standards, and government/industry regulations (GCP/ICH)■ Actively engage regional thought leaders, investigators and potential investigators in two-way scientific communication around ISS/phase IV studies■ Lead the review and approval of the concepts/protocols of Post-Authorization Safety/Effectiveness Studies (PASS/PAES), Investigator Sponsored Study (ISS) and Diagnostic Testing Programs, according to applicable SOP(s)■ Advise on locally driven early stage clinical trial plans■ Maintain up-to-date working knowledge and adherence of all applicable prevailing guidance, regulation, and law that mandates the nature in which pharmaceutical organizations function including but not limited to local health authority.1-3. Lead Medical Communication/Publication and Exchange■ Provide medical leadership and expertise to sales, marketing, legal and regulatory functions for marketed products and drugs in development.■ Lead Publication strategy planning and its execution. Lead activities related to article publications, presentations at congresses and symposia■ Provide medical review or support to the medical designee for scientific review and approval of promotional material and medical materials in compliance with corporate standards and government/ industry regulations.■ Establish and maintain contact with Key Opinions Leaders (KOLs)/ Key Thought Leaders (physicians and researchers) with high level scientific and business communication skills within pertinent medical community■ Lead to shape field strategies in line with global medical director group and local MSLs■ Develop and maintain scientific relationships with KOLs/TLs to create awareness and understanding of the therapeutic area and products, and facilitate scientific exchange with KOLs■ Fosters the establishment and maintenance of external scientific advisory boards and assists in advocacy development■ Develop and leverage medical/scientific insights through attendance at scientific meetings to further develop own knowledge base in line with company and medical strategy, and remain informed of current developments within pertinent medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, professional associations,■ Conduct/attend/present at Advisory Boards initiated by the affiliate organization if there is a clear need for specific medical input■ Support medical information role in alignment with medical information lead
求められる経験
Requirements
Education/experience
■ Degree: MD and/or PhD is mandatory. MBA is a desirable additional option
■ Min 5-year experience in R&D and/or Medical in pharmaceutical companies including at least three years of Medical Manager/Medical Advisor’s role
■ Understanding of pharma industry related knowledge including GCP, health economics etc.
■ Research and publication experience in immunology (dermatology, respiratory, rheumatology, gastroenterology etc.)
保険
健康保険 厚生年金保険 雇用保険
休日休暇
土曜日 日曜日 祝日
給与
年収1,800 ～ 2,300万円
賞与
-
雇用期間
期間の定めなし
show more
社名
社名非公開
職種
薬事、メディカルライティング
業務内容
...
Responsible for planning and executing medical activities and make sure timely and effective execution aligned to medical strategy. Reporting to TA Medical head1. Key accountabilities1-1. Lead Medical Strategy■ Lead and monitor the execution of the Japan Medical Plan to ensure on-time and on-budget delivery of all tactical activities or deliverables■ Provide medical and technical input into medically accurate development of Brand promotional materials in close alignment with marketing team and communicate the details and progress of the Medical Plan to local Medical Team, the Global Medical and all parties responsible for execution■ Work with cross-functional, multidisciplinary teams to facilitate the creation of medical strategies about products to answer unsolicited medical requests from internal and external stakeholders and ensure strategic and cross-functional alignment across the organization and any joint ventures to achieve the medical mission of supporting safe and appropriate use of a particular brand(s)/ projects■ Leverage (unmet) medical needs in order to support lifecycle opportunities based on patient needs on a rolling basis through the development cycle1-2. Evidence generation■ Liaise with key internal stakeholders to help develop, secure approval for and implement independent post approval studies that have the potential to support our company products. Review, approve and supervise all aspects of clinical study programs, including preparation of study protocols, case report forms, study reports, statistical analysis plans, clinical trial guidelines and the accurate and timely reporting of study data■ Oversee conduct of all clinical studies in adherence to both Company standards, and government/industry regulations (GCP/ICH)■ Actively engage regional thought leaders, investigators and potential investigators in two-way scientific communication around ISS/phase IV studies■ Lead the review and approval of the concepts/protocols of Post-Authorization Safety/Effectiveness Studies (PASS/PAES), Investigator Sponsored Study (ISS) and Diagnostic Testing Programs, according to applicable SOP(s)■ Advise on locally driven early stage clinical trial plans■ Maintain up-to-date working knowledge and adherence of all applicable prevailing guidance, regulation, and law that mandates the nature in which pharmaceutical organizations function including but not limited to local health authority.1-3. Lead Medical Communication/Publication and Exchange■ Provide medical leadership and expertise to sales, marketing, legal and regulatory functions for marketed products and drugs in development.■ Lead Publication strategy planning and its execution. Lead activities related to article publications, presentations at congresses and symposia■ Provide medical review or support to the medical designee for scientific review and approval of promotional material and medical materials in compliance with corporate standards and government/ industry regulations.■ Establish and maintain contact with Key Opinions Leaders (KOLs)/ Key Thought Leaders (physicians and researchers) with high level scientific and business communication skills within pertinent medical community■ Lead to shape field strategies in line with global medical director group and local MSLs■ Develop and maintain scientific relationships with KOLs/TLs to create awareness and understanding of the therapeutic area and products, and facilitate scientific exchange with KOLs■ Fosters the establishment and maintenance of external scientific advisory boards and assists in advocacy development■ Develop and leverage medical/scientific insights through attendance at scientific meetings to further develop own knowledge base in line with company and medical strategy, and remain informed of current developments within pertinent medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, professional associations,■ Conduct/attend/present at Advisory Boards initiated by the affiliate organization if there is a clear need for specific medical input■ Support medical information role in alignment with medical information lead
求められる経験
Requirements
Education/experience
■ Degree: MD and/or PhD is mandatory. MBA is a desirable additional option
■ Min 5-year experience in R&D and/or Medical in pharmaceutical companies including at least three years of Medical Manager/Medical Advisor’s role
■ Understanding of pharma industry related knowledge including GCP, health economics etc.
■ Research and publication experience in immunology (dermatology, respiratory, rheumatology, gastroenterology etc.)
保険
健康保険 厚生年金保険 雇用保険
休日休暇
土曜日 日曜日 祝日
給与
年収1,800 ～ 2,300万円
賞与
-
雇用期間
期間の定めなし
show more
