Medical Scientific Affairs Sr. Specialist / Specialist

Job description

Join us in Tokyo at B. Braun, a leader in the medical devices industry, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare! As a Medical Scientific Affairs (MSA) Sr. Specialist / Specialist at B. Braun you will play a vital role in…. Your key responsibilities: This role is responsible for collecting and reporting clinical data necessary for product development in Japan, as a CRA and as an assistant to the manager, based on SOP and related regulations. Specifically, this role will include the following Execute the clinical development activities in line with international and local requirements. Ensure basic understanding of project scope, milestones, and time codes and strive for high quality, timely, and efficient delivery. Act as B. Braun's direct contact with assigned clinical sites, use judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites. Participate in Investigator and other external or internal meetings as required. Perform on-site visits in accordance with the monitoring plan; apply judgment and knowledge to independently resolve site issues, questions and concerns. Manage and process documents in accordance with company policy. Attend audits/regulatory inspection if requested. Maintain a positive, results oriented work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner. Maintain a working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, B. Braun SOPs, other B. Braun training requirements, and study specific procedures and training. Support the global MSA activities in Japan and provide regular status updates to MSA Manager in written and oral format What you will bring to the team: Bachelor’s degree in Medical Science, Public Health, Natural Science (Biology, Chemistry etc.) or Healthcare Professionals or Biostatistics is an advantage. Minimum 7 years' experience in conducting clinical study. Medical device’s experience is an advantage. Experience in the international clinical study based on ISO14155. Excellent written English communication skills are required; strong verbal English communication skills are an advantage. Frequency of Overnight Business Travel ： Start-up phase: Approximately 50% of the week / Thereafter: At least twice per month. Competency in medical and scientific writing is an advantage. Clinical knowledge or experience in neurosurgery, interventional radiology, and/or Orthopaedic surgery is an advantage. Excellent Interpersonal Skills: effective communication and the ability to build and maintain relationships with internal/external stakeholders. Firm and Tactful: Balances assertiveness and diplomacy, handling difficult situations and conversations with professionalism, tact, and sensitivity. Flexibility: Adapts to changing circumstances and priorities. Shows resilience and flexibility in the face of challenges and ambiguity. Ethical and Professional: Upholds high ethical standards and maintains confidentiality. Demonstrates professionalism and integrity in all interactions and decision-making. Even with a complex organizational structure and reporting lines, able to gain the trust of surrounding stakeholders by maintaining appropriate levels and quality of communication. Person with high motivation / spirit of challenge at work: Able to proactively identify necessary resources and request support to effectively carry out tasks. What sets B. Braun apart? B. Braun Aesculap Co., Ltd is a leader in medical technology and healthcare solutions, established in 1986 as a Japanese subsidiary of the B. Braun Group founded in Germany in 1839. Headquartered in Tokyo and with over 500 employees, we are committed to improving patient care through innovation and excellence in the manufacturing, selling, repairing and importing/exporting medical equipment. At B. Braun, we foster a culture of trust and collaboration, ensuring compliance with the highest ethical standards. Be part of a team that makes a difference. Apply now and contribute to our shared vision - to protect and improve the health of people around the world. What can we offer you? Flexible work hours and hybrid work style Attractive compensation - fixed bonus twice a year and annual performance bonus Comprehensive social insurance Retirement allowance system (3 years+ of service) Benefit station subscription 123 days off per year and annual paid leave Influenza vaccination assistance Reduced working hours for childcare (for children up to the sixth grade of elementary school) Company-implemented government childcare subsidy program What’s next? Once you click on the link to Apply, you will be directed to update your personal information and submit your CV. Our Talent Acquisition team will carefully review your application, and if you pass the CV screening you will be invited for the first interview. All candidates will complete a web assessment followed by 2 to 3 interviews (online or in-person). If you stand out and meet our requirements, we will present you with an offer and guide you through our seamless onboarding process. Join us and be part of something extraordinary! We appreciate different perspectives, thoughts, experiences and backgrounds. By strengthening an appreciative, inclusive, respectful and equal working environment, we create a culture in which all our employees feel free to be who they are. ビー・ブラウンエースクラップ株式会社の情報はこちら Website： YouTube： LinkedIn： お問合せ窓口 人事総務本部 採用担当 E-mail: 採用ページ：