Senior Specialist Patient Operations ・ Apheresis

【求人No NJB2423094】
Senior Specialist Patient Operations ・ Apheresis is accountable to manage onboarding and on going performance of Apheresis Centers used for BMS Clinical and Commercial Chimeric Antigen Receptor （CAR） T cell Therapies. This role will serve as the technical operations single point of contact for Apheresis Centers located within the designated region of APAC.
This role will be based out of the corporate offices in Tokyo Japan. Travel up to 30% of time within Japan and Asian Pacific region may be required.
Come join BMS for this unique opportunity to be part of the team building a leading edge Clinical and Commercial CAR T Platform that serves our patients with novel BMS CAR T Therapies.

◆Responsibilities will include but are not limited to the following:
・Develop and foster relationships with Apheresis Center Staff for assigned region.
・Work with Clinical and Commercial CAR T teams to establish the apheresis collection footprint to support the clinical trial and commercial site plans for assigned region/country.
・Coordinate with internal teams and collection site staff to ensure all collection site onboarding activities are successfully completed and sites are prepared to perform collections for BMS within the required timelines.
・Communicate collection site on boarding status to Clinical and Commercial teams and develop and execute mitigation plans for any delayed timelines.
・Perform technical site assessments and train collection center staff on BMS collection requirements and attend site audits as required
・Provide Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centers.
・Work with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity after site launch.
・Manage rollout of process changes to assigned sites.
・Collect VOC （voice of customer） and VOB （voice of business） feedback used for continuous operations improvement
・Collect and enter data into electronic data management systems
・Represent the department on cross functional project teams as requested.
・Comply with applicable SOP’s and regulations.

◆Qualifications and Experience Requirements:
Ability to rapidly solve problems and deal with organizational complexity
Ability to prioritize and complete work with sense of urgency based on criticality
Medical scientific and clinical knowledge
Knowledge of applicable regulations and standards
High attention to detail skills
High organization skills with ability to multi task several tasks in parallel
Required Undergraduate Degree （in Medical Life Sciences or Engineering preferred）
Required minimum 5 years of experience in a regulated environment either hospital or pharmaceutical/biotech
Required English proficiency at a beginner business level or higher （TOEIC score of 650 or above）

◆Preferred but not required:
Medical professionals （nurses pharmacists clinical laboratory technicians clinical engineers etc.）
Experience working in Apheresis Cellular Therapy or Stem Cell Transplant programs
Prior customer facing role in pharmaceutical/biotech industry
Experience as a Clinical Research Associate （CRA）
Experience in training healthcare professionals