【Purpose & Scope】
・アステラス製品の有効性・安全性・品質についての社外問合せ対応(二次対応)
医療従事者(HCP)は、最良の患者ケアを提供するために最も信頼できるデータを求めています。患者は、自分自身を健康に保つために信頼できて、わかりやすい情報を必要としています。メディカルインフォメーションセンターのメディカルコミュニケーターは、アステラス製品、疾患に関する正確で科学的な情報を提供します。情報提供の際、必要に応じてCRD(Custom Response Document)を作成します。
・問合せ対応から入手したVoC (Voice of Customer)情報の収集・分析、得られたInsightを社内ステークホルダーに共有します。
・安全管理実施部門として、問合せ時の安全管理情報は専門部へ速やかに報告します。
【Essential Job Responsibilities】
Oversight and strategic lead for Medical Information function for the assigned therapeutic area. This includes:
•Develop and oversee the strategy or operations of Medical Information function for assigned TA(s) through consolidation of input from appropriate stakeholders with identification of key clinical issues, gaps, and/or process improvements.
•Identify new and innovative solutions to fill the gaps related to Medical Information function, and manage, develop, review, and maintain specific ongoing or new projects or operations regarding Medical Information as assigned.
•Manage, develop, review, and maintain Medical Information projects or operations as assigned. This may include collaborating with product partners and other internal and external stakeholders.
•Contribute to Japan Core Medical Team (J-CMT) as Medical Information representative.
•Contribute to the development and implementation of J-CMP for assigned project(s)
•Bring expertise related to the function to Medical Information group.
•Manage the role allocation and work load in assigned TA(s)
•Document in Global Medical Information Database (GMID) and respond to unsolicited requests from HCPs and patients with appropriate data
•Interpret Medical Information data to generate insights and gap analyses
•Conduct product and process training for contact center vendor staff and other departments as requested
•Monitor Medical Information key performance indicators
•Review standard/custom response documents for medical accuracy and veracity, as assigned
•Collaborate with groups outside Astellas MA, Japan (Medical Information global, Patient Centricity, Patient Advocacy, Legal, Commercial, E&C, etc.) as appropriate
•Responsible for active participation on Japan Core Medical Team as assigned
•Verify Medical Information Request Web Forms from the Medical Representatives are unsolicited per applicable country requirements
•Report potential adverse events and potential product complaints per Astellas policy and established processes
•Ensures effective communication between internal and external groups regarding Medical Information.
•Works proactively and in collaboration with stakeholders to identify and manage constraints and risks, facilitating resolution
•Ensure compliance and transparency within processes and procedures of Medical Information in alignment with Legal / Regulatory /Compliance
•Develop and maintain compliance relevant to regional legislation, regulations and internal Astellas policies.
•Remain current on regional and local regulations.
•Develop and maintain regional quality documents required for local needs, aligning with global quality documents.
•Oversee the outsourced vendor related to the preparation and/or review of promotional/non-promotional material.
Quantitative Dimensions:
•Oversee across multiple products in assigned TA(s)
•Identification of gaps in policy/procedural areas of Medical Information
•Interacts with and influences internal and external stakeholders effectively regarding system and quality document issues
•Direct impacts compliance with: regulatory/safety/legal requirements of the regional regulatory agencies, regional and international pharmaceutical codes, and internal Astellas policies
•Fulfillment of escalated unsolicited medical information inquiries, quality monitoring of these activities as assigned
•Handling multiple projects with a high level of efficiency
•Collaboration with global groups, vendors and other Astellas colleagues as appropriate for project.
Organizational Context:
•Reports to the Team Lead, Medical Information Escalation-Japan, Global Medical Information.
•Works in a matrix environment; collaboration with leadership and product teams, collaboration with stakeholders at varying levels including, but not limited to Medical Affairs, Commercial, Legal, Compliance, Regulatory and Pharmacovigilance.
•Provides leadership for new and ongoing initiatives across Medical Communications.
【Specific Physical or Environmental Requirements】
•This position is based in Tokyo, Japan.
【Qualifications】
<Required>
•Bachelor’s degree or higher in the field of life science
•At least 3 years clinical practice experience and/or pharmaceutical industry experience
•In depth medical/scientific knowledge of assigned products and TA.
•In depth knowledge of statistics, medical/scientific terminology and medical writing.
•Ability to review/understand complex scientific and medical data from clinical and non-clinical trials and summarize content in both written and verbal forms is needed
•Has excellent understanding of legal/regulatory/compliance requirements and guidelines with respect to Medical Information/ Medical Affairs in the pharmaceutical industry
•Advanced knowledge of the advantages and disadvantages of available medical references and online literature searching
•Excellent oral and written communication skills, presentation skills and basic negotiation skills
•Ability to be logical and strategic thinking
•Basic proficiency in English (written/oral/presentation)
<Preferred>
•Experience working on global team or in a global environment
•Advanced proficiency in English (written/oral/presentation)
•Healthcare professional (e.g. pharmacist, nurse) with a Bachelor’s degree or higher.
【応募書類 / Application Documents】
和文履歴書(必須)・和文職務経歴書(必須)・英文レジュメ(任意)
Resumes
【選考プロセス / Selection details】
書類選考 → 1次面接 → 最終面接
※変更の可能性もございますので、予めご了承下さい。
CV screening → First interview → Final interview
*Please be advised that there might be a change in the process.
【勤務地 / Location】
(雇入れ直後)
東京都中央区 アステラス製薬 日本橋事業所 本社
Nihonbashi, Tokyo
(変更の範囲)
会社の定める事業場および自宅
【勤務開始日 / Start Date】
応相談
Will be decided according to the candidate's flexibility
【契約期間 / Contract Duration】
期間の定めなし
Not limited to specified period
【試用期間 / Probation Period】
試用期間原則なし
No probation period in principle
【給与 / Salary】
①基本給:当人の経歴・技術・技能等を考慮して決定
②裁量労働制の場合:裁量労働手当として職務グレードに応じて50,000~100,000円支給
③フレックスタイム制の場合:月間の所定労働時間を超えて勤務する時間に対して時間外勤務手当を支給
①Base salary: will be decided by the candidate's experience, skill and capability.
②When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000~100,000yen, based on the Grade)
③When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.
【昇給 / Salary Raise】
有り
【賞与 / Bonus】
有り
【諸手当 / Allowance】
裁量労働手当、住宅手当、通勤手当 等
Discretionary work allowance, Housing allowance, Commutation allowance, etc.
【勤務時間 / Working Hours】
8:45~17:45(月~木)、8:45~16:00(金)、企画業務型 裁量労働制
裁量労働制の場合、所定労働時間を働いたものとみなす
8:45~17:45(Mon~Thu)、8:45~16:00(Fri)
Discretionary Work System
【休日 / Holidays】
完全週休2日制(土曜・日曜)、祝日、5月1日、夏季、年末年始
Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays
【休暇 / Vacation Leave】
年次有給休暇、育児休業制度、介護休業制度 等
Annual paid leave, childcare leave system, nursing care leave system, etc.
【福利厚生 / Welfare】
雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度 等
Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System
【アステラス製薬 採用サイト/ Career web site】
https://re-jp.astellas.com/jp/recruit/newgraduates/
For more information about Astellas, please visit our career web site.
"We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law."