16821 Medical Publication Lead
・Contribute the medical value of the products and therapeutic areas through dissemination of scientific publications.
・Secure smooth operation through effective communications with external/internal stakeholders.
・Actively contribute to the objectives achievement and system / process improvement of Division / Department as a member of Japan Medical.
・Contribute to realize the Value Statement of Medical Publication as a member of WW Medical Capabilities through the collaboration and cooperation with the internal stakeholder, Head Quarter, Japan-medical capabilities and alliance companies.
・As Publication Lead, be accountable for the medical/scientific aspects of the scientific manuscripts as well as domestic and international congress presentations and posters developed by the company.
・Preside over author’s meeting upon the initiation of a publication process by collaborating with internal stakeholders
・Drive medical/scientific discussions within the authors and major stakeholders, and reflect the discussions / consensus to the publication in a scientifically appropriate way.
・Manage each publication projects by tracking the progress, assuring quality, keeping cost within budget and handling issues ・Collaborate and communicate with internal stakeholders like Medical Lead, HEOR, Development lead, WW Publication lead and WWl Medical Lead as well as external stakeholders like external authors and medical writing vendors.
・Develop and maintain publication plan in the company including timing, budget and resources. Report them upon request.
・Standardize the timely, accurate and effective procedure of publications in collaboration with WW Publication lead.
・Provide trainings to internal and external stakeholders for the company’s publication procedure and backgrounds.
・Knowledge of general process of publications, International committee of medical journal editors (ICMJE) recommendations, Good Publication Practice (GPP) guidelines, and the company’s scientific publications SOP. ・Knowledge of medical, pharmaceutical or life-science field at advanced academic degree level. Can understand details of the topics related to the products from scientific, physiological and pharmacological viewpoint. Knowledge of assigned therapeutic area (disease mechanism, epidemiology and typical treatment in Japan) and products at medical function-required level. ・Basic knowledge about clinical development (Ph1-4), post-marketing safety monitoring activities such as EPPV and PMS in Japan, and healthcare system in Japan. Detailed knowledge about product-related data scheme including phases and composition of clinical development, characteristics of data from Japanese EPPV and PMS, architecture of Common Technical Document etc. ・Knowledge about Medical Affairs Law, Fair Competition Code (FCC), Promotion Code, Guideline for Clinical Research (MHLW) and any other applicable regulations in Japan. ・Teamwork skills to nurture trust and confidence with internal stakeholders. ・Skill to demonstrate the company’s values, passion, innovation, accountability, urgency, inclusion, integrity. ・Proficient communication skill in Japanese and English
・Development of publications in English science journal is mandatory ・B.S. in medical / pharmaceutical / veterinarian / life-science area is mandatory. Ph.D. in these area is preferable ・Holder of ISMPP Certified Medical Publication Professional (ISMPP CMPP) is preferable.