General Information
Job Advert Title:
Medical Writing, Clinical Transparency Scientist
Location:
Nihonbashi, Tokyo
Division:
Clinical Operations, Quantitative Sciences and China Development
Employment Class:
Permanent
Description
【About Astellas】 Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. （HP:
Learn more about Astellas） Are you driven to make a real difference in the lives of patients? We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
【募集の背景 / Purpose & Scope】 • Execute the clinical transparency (i.e., registration, updates and/or results disclosure) or public disclosure processes for assigned studies and/or assets conducted by Astellas globally. • Create documents (i.e., plain language documents, redacted documents, public disclosure plan) necessary to support clinical transparency and public disclosure. • Demonstrate proficiency in clinical transparency or public disclosure activities. • Contribute toward the establishment and refinement clinical transparency or public disclosure processes while ensuring adherence to all applicable laws, regulations, industry guidance and corporate position. • Monitor global regulatory requirements and the industry environment affecting clinical transparency or public disclosure and communicate changes to fellow team members.
【職務の内容 / Essential Job Responsibilities】 （雇入れ直後） 1. Prioritizes, and performs the day-to-day operations of Clinical Transparency or Public Disclosure, ensuring the timely completion, review and approval of registration, updates and results disclosure activities or public disclosure strategy plans and public disclosure tracking mechanisms for studies and assets conducted globally. 2. Makes appropriate decisions regarding the applicability and timing of clinical transparency or public disclosure activities according to national laws, regulations, industry guidance and corporate position. 3. Manages the review and approval process for Clinical Transparency (clinical trial registrations, updates and results disclosures) and related documents (plain language and redacted documents) or public disclosure strategy plans and public disclosure tracking mechanisms, including communication with partner companies or collaborators. 4. Facilitates periodic review of active registrations or public disclosure strategy plans to ensure records are updated or verified as required. 5. Uses independent judgment to assess clinical transparency or public disclosure activities prioritization and appropriate problem solving to determine escalation of issues to management. 6. Addresses inquiries related to clinical transparency and related documents or public disclosure activities. 7. Interacts and collaborates across various departments and management levels within Astellas to ensure open and effective communication. 8. Provides feedback to clinical transparency or public disclosure leadership resulting from new and updated transparency requirements. Ensures compliance with evolving clinical transparency or public disclosure requirements, including retrospective review and work as necessary. 9. Contributes toward the continuous improvement of global clinical transparency or public disclosure processes, procedures, and standards. 10. Establishes and maintains global working relationships.
（変更の範囲） 会社内での全ての業務
【就業環境に関する要件 / Specific Physical or Environmental Requirements】 • At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
【応募要件 / Qualifications】 ＜必須 / Required＞ • Bachelor’s Degree, or equivalent experience required. • Proficient organizational skills and high attention to detail. • Self-directed and motivated, with ability to work without significant direct supervision, asking questions when necessary. • Ability to manage multiple tasks and readily switch activities to accommodate priority needs. • Proficient computer skills, including experience with MSWord and Excel. • Business-level proficiency in both English and Japanese • Pharmaceutical professional background.
＜歓迎 / Preferred＞ • 3 years pharmaceutical industry experience in writing content for Clinical Transparency purposes. • Clinical trials experience including study management, statistics, medical writing and / or data management preferred. • Working knowledge of clinical drug development and clinical trial protocols preferred.
【応募書類 / Application Documents】 和文履歴書・和文職務経歴書・英文レジュメ Both Japanese and English Resumes are needed
【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 → 2nd 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）、専門業務型 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."
【What awaits you at Astellas? 】 •Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide. •Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day. •Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare. •A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
【Our Organizational Values and Behaviors】 Values: Innovation, Integrity and Impact sit at the heart of what we do. Behaviors: We come together as ‘One Astellas’, working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.
