Medical Science Liaison， 炎症・免疫 / 外資製薬メーカー
|職種||Medical Science Liaison， 炎症・免疫|
Medical Science Liaison (MSL)s are responsible for developing and enhancing professional relationships with medical / patient advocate /etc thought leaders involved in various phases of product development. MSLs provide both non-branded / branded medical information through scientific exchange in a fair-balanced manner to increase awareness of compounds’ characteristics and provide clinical/scientific support
・Identify Key Opinion Leaders (KOLs)， and establish and maintain scientific relationships with KOLs; connecting KOLs in academic and community centers.
・Act as primary liaison to investigators interested in developing and performing investigator initiated trial/research.
・Develop and execute Medical Brand Plan.
・Contribute to the development of Medical strategies.
・Provide clinical presentations and information in response to unsolicited questions (as appropriate) in academic， community， and healthcare provider setting both in group and one-on-one situations.
・Lead brand data building.
・To be recognized for an advanced knowledge of our products and clinical pipeline， research strategy ＆ the competitive landscape.
・Provide medical insight and interpretation of relevant data to internal colleagues.
・Develop and present internal therapeutic area training modules. Provide congress updates and act as a point of medical/scientific expertise internally for ad-hoc as well as structured training requests.
・Collaborate with the Clinical organization to enhance patient enrolment in our clinical trials by identifying appropriate clinical trial sites and interacting with investigators in ongoing studies.
・Provide timely feedback/information on emerging clinical/scientific teams and opportunities to internal stakeholders.
・Drive our specialized company by stakeholders throw medical activities
・BS degree in scientific and/or medical discipline required; M.D.， Ph.D. strongly preferred.
・Minimum 3 years experience in medical affairs or clinical development， experience in inflammation， immunology TA strongly preferred.
・Proven ability to work independently as well as in cross-functional networks.
・Current working knowledge of Japanese legal， regulatory and compliance regulations and guidelines relevant to industry interactions with health-care professionals.
・Ability to partner and maintain relationships within the medical community.
・Excellent communication， presentation and time management skills.
・Willingness to travel as needed
|年収||850万円 - 1300万円|
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1.Maintenance -Ensure equipment functionality and reliability. Maintain all production equipment， facilities and utilities in an effective operating and compliant state. -Equipment qualification， documentation and change control. Ensure that changes to equipment and systems are carried out， qualified， and documented according to approved change control procedures. 2.Engineering -Planning for Engineering Project aligned with quality ＆ EHS requirements and with the local and global strategy. -Engineering compliance， to provide necessary guidance to ensure compliance with all applicable external and internal regulations and requirement regarding quality and EHS. -Manage engineering budget， run an efficient and effective engineering activity through managing the engineering site budget and resources. 3.People ＆ Organization -Lead a professional engineering team， by identify， develop and retain qualified people to provide engineering and maintenance services. -An influential functional expert within the site management team. Influence decision making and take an active role in promoting cross-site initiatives， collaboration across site’s functions. -Implement global best practices and actively share knowledge and lesson learned to contribute and support a high professional level of engineering globally.
＜Job Description＞ Ensuring the analysis and presentation of biomedical data is accurate and complete. Adherence to Amgen Policies， SOPs and other controlled documents
＜Group Purpose＞ Facilitate patient access to Amgen products in Japan through executing the development and regulatory plans; providing strategic regulatory expertise; interfacing with agencies on regulators; aligning with key cross-functional partners; integrating into Amgen’s commercialization process， and continuously improving our processes and developing our talent ＜Job Summary＞ Support the tactical execution and detailed deliverable to support Regulatory Activities including CTN， PMDA consultation， and NDA (eCTD) ＜Key Activities＞ *Oversight service providers for eCTD and/or e-Data *Execute preparation， compilation， and submission of regulatory dossiers according to Japanese requirements *Ensure the contents and format of dossiers conform to internal and external guidelines and regulations *Provide guidance to global teams on the structure of regional dossiers and eCTD Japan specific requirements *Document management *Responsible for ensuring quality control procedures for dossiers and components are in place and adhered to *Evaluate and ensure timely data entry for regulatory registration tracking system *Participate in the development and maintenance of policies， SOPs and associated documents for GRAAS Japan