Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position Summary

Lead the authoring of clinical/regulatory documents in Japan.

The scope of clinical/regulatory documents includes clinical study reports (CSR) for local Ph 2 or 3 study, regulatory submission documents (CTD), briefing document for PMDA consultation, regulatory response documents, orphan drug designation.

• Lead the authoring of clinical/regulatory documents and support the performance goals (including quality and timeline) for the clinical development and regulatory submission in Japan as planned by the R&D Development Teams.
• Establish cross-divisional cooperative partnership with other functions according to the optimized and standardized processes and systems.
• Fulfill the role of Japan Documentation Lead.

Duties/Responsibilities

Play the following roles and take responsibilities at each phase in the life cycle of the BMSKK asset;

• Build the storyboard to author regulatory dossier policies and align with global team based on the information provided by DT.
• As DOC lead, understand the global authoring regulatory dossier strategy and lead the finalizing of domestic regulatory dossiers of clinical part.
• Set an appropriate and the shortest timeline to complete authoring regulatory dossiers and comply with the timeline.
• Propose to the team the optimal strategy for preparing regulatory submission documents based on the tendencies of each review division concerning the contents of PMDA review reports and inquiries.
• Complete the clinical modules with J-CDL/J-CS based on the storyboard.
• Manages and provides global submission materials to stakeholders as needed.
• Authoring and conducting a coordinating activity as CSR author.
• Take charge of the CSR authoring part in the inspection.
• Manage the operational execution by strategically using outsource vendors and ensure quality of deliverables.
• Comply with internal and external processes and guidelines.
• Review and edit other clinical/regulatory documents as required.
• Drive continuous process improvements by identifying and simplifying processes. Lead implementation of business process improvements based on information from collected metrics.
• Give advice to other scientific writers to help them improve their capabilities in creation of clinical/regulatory documents for Japan.
• Provide additional value by creating better collaborative work environment internally and externally to ensure that Japan team has a good communication with HQ counterparts as well as key stakeholders, such as clinical research and regulatory.

Qualifications

B.S. in medical / pharmaceutical / veterinarian / life-science area or three years or more experience in either pharmaceutical R&D industry is mandatory.

• PharmD/PhD/MD in a relevant scientific discipline, or MS/BS with a minimum of 3 years (MS) to 5 years (BS) in preparing regulatory submission documents or have equivalent credentials and experience.
• Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities.
• Good understanding of the tendency of each review department of PMDA regarding the contents of review reports and inquiries.
• Demonstrated ability required for strong writing skills both in Japanese and in English, preferably in authoring and leading the production of clinical/regulatory documents for submission to PMDA. Samples of required and experienced abilities are the followings:
• Capable of updating appropriately the first draft of M2.5.1 and M2.5.6 authored by J-CDL/J-CS and providing appropriate advice when authoring the first draft, or can prepare the first draft in collaboration with J-CDL/J-CS
• Capable of independently finalizing other clinical modules getting cooperation from R&D Development team.
• Also, capable of independently authoring the draft inquiry to regulatory regarding clinical matters.
• Experience in authoring the clinical part of the pre-JNDA/Eop2 consultation documents.
• Capable of communicating with the Global team about the contents/strategies of the authoring documents such as CTD module and the response to inquiries.
• Ability to analyze and interpret complex data from a broad range of scientific disciplines.
• Excellent organizational communication, facilitation and interpersonal skills in a cross-functional team.
• Demonstrated ability to manage timelines and keeping quality of work.
• Working knowledge of a document management system.
• Skills to appropriately manage CROs or translation vendors.
• Skills to read scientific documents in English and communicate with the global members both in English.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position Summary

The Senior Scientist will serve as the designated point of contact for Aichi and the analytical network, frequently interaction with global analytical science and product development teams. The incumbent will be subject matter expert for the analytical portion of new product introduction and for a number of test methods/processes across multiple products, anticipate and perform complex troubleshooting and problem-solving independently.

The incumbent will manage and deploy, in collaboration with other QC members, continuous improvement and simplification initiatives. 

This role will own generation of protocols and reports, and other documents aligned with regulatory and corporate guidelines. The Senior Scientist will also represent the department in product review boards and regulatory inspections, both internal and external, and may author responses to regulatory requests.

They will lead transfers, validations, projects, CAPAs, and deviations/investigations, and continuous improvement efforts.Furthermore, the Senior Scientist will train and mentor others on multiple QC test methods, processes, and procedures and perform other tasks as assigned.

Duties/Responsibilities
 

General Level Responsibilities

• Designated Subject matter expert for a number of test methods/processes across multiple products
• Leads method transfer & validation of in-process, final product, and stability methods specifically focusing on new product introduction
• May own scheduling of assignments in consultation with manager.
• Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines.
• Represent the department in product review boards and regulatory inspections (internal and external audits).
• May author responses to regulatory requests.
• Lead projects, CAPAs and deviations/ investigations and/ or continuous improvement efforts.
• Anticipate and perform complex troubleshooting and problem solving independently.
• May represent the department in regulatory inspections (internal and external audits).
• Train and mentor others on multiple QC test methods, processes and procedures.
• Perform other tasks as assigned.
• Owns and contributes to change controls.
• May act as delegate for laboratory management, as required. 
• Perform release/stability testing for complex and non-complex methods on intermediate or finished product as required
• Identifies and escalates challenges & barriers to execution, suggests solutions, and lead remediation.
• Champion and foster a positive, supportive, and collaborative quality culture.
• Actively and positively participates or leads in Operational Excellence (OpEx) and Continuous Improvement (CI) initiatives in the team
• Complete all required tasks compliantly and safely while consistently and intentionally modeling BMS values (Integrity, Accountability, Passion, Urgency, Innovation, and Inclusion).

Key Job Competencies

• Advanced ability to understand, follow, interpret and apply Global Regulatory and cGMP requirements accurately and completely.
• Demonstrated advanced technical writing skills.
• High problem-solving ability/mentality, technically adept and logical.
• Excellent attention to detail and demonstrated organizational skills.
• Ability to communicate effectively with peers, senior leaders and stakeholders across multiple departments and sites also in English
• Demonstrated strategic & enterprise thinking
• Advanced ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Advanced use and knowledge of LIMS, ELN and laboratory data analysis.
• Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills.

Role Specific Assignments:

• Lead analytical test method transfer for new product launch
• Lead alignment of CoA and test method of DP site with External Manufacturing or BMS sites for MRA application
• Lead introduction of analytical instruments
• Lead Continuous Improvement Initiatives and enhancement of GMP compliance in QC lab

Qualifications

• Bachelors Degree in a non-technical discipline with ≥13 years experience, or
• Bachelors Degree in a Scientific or relevant Technical area  with ≥9 years experience, or
• Masters Degree in a Scientific or relevant Technical area with ≥7 years relevant experience, or
• PhD in a Scientific or relevant Technical area with ≥5 years relevant experience.
• Able to write, read, and speak English fluently
• An equivalent combination of education and experience, preferably in a regulated environment will be considered.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position Summary

The Japan Clinical Trial Physician sits within Clinical Development, which is dedicated to the effective design and execution of drug development. Clinical Trial Physician contributes and drives clinical development strategy, design, execution, and interpretation of clinical trials closely working with Japan Clinical Leads and global clinical counterpart.

Duties/Responsibilities

Medical Monitoring

• Conducts medical data review of trial data, including eligibility review
• Holds responsibility for site interactions in partnership with the Japan Clinical Lead or Clinical Scientist for medical questions and education (including safety management guidelines)
• Holds responsibility for assessment of key safety-related serious adverse events of R&D clinical trials in partnership with Worldwide Patient Safety and oversees safety narratives
• Collaborate with Japan Clinical Lead or Clinical Scientist and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
• Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
• The range of CTP’s medical accountability/responsibility differs in global vs local studies. For global studies, Japan CTP is assumed to assist global CTP as needed from local perspectives, e.g. provide local medical related input, resolve local medical related issues.
• Japan CTP could be expected to take a primary CTP role for local initiated trials or program

Clinical Development Expertise & Strategy

• In collaboration with the Japan Program Development Team such as Clinical Lead, designs and develops project/clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets
• Provides oversight and medical accountability for a group of studies
• Leads the analysis of benefit/risk for clinical development protocols and projects in a matrix team environment working with Japan TA
• Partners with Japan the Japan Program Development Team such as Clinical Lead to support executional delivery of studies (e.g., enrollment review, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
• Identifies and builds relationships with principal investigators. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs
• Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Holds strong expertise in the disease area by attending scientific conferences and ongoing review of the literature
• Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape
• Provides ongoing medical education in partnership with collaborating Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and others

Health Authority Interactions & Publications

• Contributes to and serves as medical point of expertise in key Health Authority interactions and advisory board meetings as Clinical Trial Physician
• Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with TA such as Clinical Lead or Clinical Scientist

Concurrent role with Japan Project Lead role or Japan Clinical Lead role (if applicable)
 

Qualifications

Education/Experience/ Licenses/Certifications:  

• MD is required, Ph.D. is highly recommended
• Deep/extensive knowledge on all over clinical development that is equivalent to 5-10 year-experiences
• Broad knowledge on full process of pharmaceutical development and its regulatory guidance/guidelines
• Ability to propose and execute improvement and innovation in TA and cross-TA works
• Skills of budget planning and resource management
• Good communication skills in both Japanese and English
• Strong leadership qualities with the ability to create a culture of collaboration and teamwork that fosters open communication, constructive conflict, and organizational flexibility
• Excellent interpersonal skills, with the ability to build relationships, act as a change agent, and adapt to rapidly changing organizational and business issues
• Broad and in-depth understanding of domestic and international issues relative to the industry
• Experience to assure business compliance and control within the compliance obligations, Sarbanes Oxley and other audit requirements
• Expertise in the components needed to execute an effective clinical plan and protocols

Key Competency Requirements:

• Ability to deliver the outcomes under the ambiguity or complexity
• Ability to partner with people at all levels of the organization
• Ability for proactive proposal building and proactive action takings without detailed instructions
• Ability to respond flexibly to the changing project/task priorities and work assignments.
• Ability to influence and negotiate without specific authority.
• Ability to take a risk and to manage it without jeopardizing quality and/or compliance
• Ability to build action plans based on the organization vision
• Acts to makes a balance between short-term performance and long-term vision.
• Fluent in spoken and written English & Japanese for business is preferred

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

概要 (High-level Description; including manage team/individuals or not)

This is a key role in BMSKK Controllership team and will be responsible for managing critical assignments for both BMSKK and BMSH entities to accomplish the tasks of USGAAP reporting, Statutory filing and Taxation. Matrix manager with oversight of Controllers Team and LE CoE, Stat CoE and capability centers.

役割と責任範囲 (Roles & responsibilities)

• Oversee and review month-end/quarter-end/year-end closes including BS/PL analysis which will be managed by LE CoE, Stat CoE and capability centers.
• Ensure that financial statements are accurate, complete and in accordance with accounting standards (USGAAP and JPGAAP).
• Manage Corporate Income Tax, Consumption Tax, Office Tax, Fixed Asset Tax, Withholding income tax, Revenue stamp tax and Transfer Pricing/APA taxes related topics for BMSKK and BMS Hanbai KK.
• Manage respective local tax filings, including supporting outsourced Corporate Income Tax and Consumption Tax filing process, and ensures that they are in compliance with local market requirements.
• Facilitates external/internal audits and manage interactions with the respective auditors collaborating with Legal Entity CoE, Statutory CoE and other capability centers.
• Facilitates tax audits and manage interactions with the respective auditors/authorities, PwC tax team and Tax CoE.
• Collaborate with Tax CoE and Corporate Transfer Pricing team to be aligned with critical Tax and TP related topics to ensure in an appropriate position.
• Oversee budgeting/projections for Legal Entity (LE) profitability and quarterly profitability adjustment process as well as monitoring necessary Transfer Price changes which are managed by LE CoE.
• Oversee Intercompany back charges, alliance related transactions and pension activities, which are managed by LE CoE, Stat CoE and other capability centers.
• Engage as a Local Technical Accounting Network (TAN) and collaborates with Corporate TAN to obtain relevant USGAAP and finance SOP updates.
• Liase with Controllers Team, Corporate Treasury, LE CoE, Stat CoE and other capability centers and demonstrates accountability to contribute creating a high-performance culture with an enterprise mindset.
• Engage as a Subject Matter Expert for cross functional projects as well as Statutory and USGAAP requirements advisor.
• Establish relationships and cross-functional partnerships through demonstrated integrity to create value for the business to meet organizational objectives and governance responsibilities.
• Utilize proper influence skills to obtain positive outcomes and make decisions that align with the strategic direction of the organization.
• Drive team performance by promoting and encouraging participation and sharing of ideas that align with the organizational strategy and maximize goals.
• Create a workplace where employees are inspired, encouraged and valued.

必要な知識/スキル (Required knowledge/skills)

Knowledge:

• Undergraduate degree in accounting, finance or related field.
• CPA, MBA or equivalent qualification.
• Knowledge of Japan GAAP and Japan tax regulations
• Minimum of 10 years of relevant experience in Finance.
• Minimum of 5 years of working experience in global and/or multi-divisional organization.
• Experience within the pharmaceutical industry – preferable.

Skills:

• Experience of manger/supervisor in multi-national environment.
• Experience of leading tax filing processes, cross functional project, and financial close.
• Intellectual/emotional capability and commitment exercising a high degree of adaptability in dealing with diverse work environment.
• Inquisitive, initiative and willing approach in the acquisition of new tasks and the ability to prioritize and be independent in completing set objectives.
• Competent analytical and problem-solving skills, with strong written and oral presentation abilities.
• Competence in using a variety of applicable software (including SAP, Oracle, Hyperion, and Concur) to perform business tasks.
• Fluency in English and Japanese (reading/writing/speaking/listening).

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

IO sales：免疫肿瘤客户主任/高级销售代表

主要职责 (岗位相关):

• 有深入的产品知识和疾病领域知识
• 达成/超越区域目标
• 执行市场经理阐明的市场战略。从恰当的细分市场里甄别出目标HCP并与之合作, 达成推广计划
• 充分了解所在地区和所负责区域的关键HCPs
• 更新客户数据
• 协调当地的“院内会议”
• 及时更新HCP的信息，根据计划进行拜访。
• 建立和维护和关键HCP的联系, 理解客户(医学)需求。
• 达成并保持公司关于拜访率、知识水平、能力、行为和个人形象方面的要求。
• 定期（每天）在ETMS 系统中报告拜访情况。
• 提供准确的报告，并且根据规定的流程联系直接主管。
• 提供给直接主管关于BMS 推广材料有效性的信息。.
• 通过参加培训、会议、和自学医学文献以发展和提高专业知识
• 和团队成员分享自己的知识和经验。
• 管理好专业设备和促销资料，确保完好。

岗位要求

• 具备医药，生命科学相关本科以上学历
• 熟悉当地医院的推广工作
• 1-3 年销售经验
• 有肿瘤经验者优先考虑
• 具备良好的人际沟通技巧，团队合作精神，能独立分析解决问题并在压力下工作。

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position Summary / Objective：

Responsible for the oversight of the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

Act as one of the points of contact at a Site level for internal and external stakeholders.

Position Responsibilities

• Identifies new potential Investigators, through ongoing collaborations with internal and external stakeholders.

• Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials.

• Develop Site relationships (incl. Contract Research Organization related issue management and non- registrational /Investigator Sponsored Research Studies).

• Recommends sites during the site feasibility and/or site selection process

• Conducts pre-study visit as appropriate.

• Conducts initiation visits to ensure Investigator and site personnel receives adequate protocol specific training prior to site activation.

• Reviews site activities and quality through on-site and off-site visits. Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan, BMS procedural documents, protocol, ICH/GCP Guidelines and other local regulations as applicable.

• Perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor.

• While monitoring demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions.

• Serve as a point of contact for Sites.

• Provides trainings to sites.

• Performs site closure activities when all required protocol visits and follow-up are completed.

• Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.

• Ensures completeness and quality of data submitted from study sites.

• Ensures eCRF data is available and current by using the available systems to follow site activities. Oversees activities of site personnel over whom there is no direct authority.

• Motivates/influences the site to meet study objectives, including enrolment and retention goals. Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method.

• Anticipates, identifies and proactively supports site in resolving issues as they occur. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team. Initiates, recommends, documents, and communicates corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implemented.

• Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions.

• Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner.

• May support Ethics Committee submission, ICF review, collection of documents to/from site.

• May support ensuring access to eDC and BMS / vendor systems is available for clinical trial site personnel.

• May support equipment calibration and tracking.

• May support preparation of Study Initiation Visit materials.

• May support coordination and ensure database lock timelines are met as required locally.

Senior Level Expectations:

• Proactively identify and resolve potential problems at both site and country level.

• Engage with Clinical Trial Manager and/or line management to assist in the resolution of more complex issues.

• Proactively seek to enhance communication skills with both internal (Global level) and all relevant external parties and coaches others to do the same.

• Contribute significantly to study team and coaches site staff to enhance site and hub performance.

• Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other team members through a mentoring process using informal and/or formal presentations.

• May assist line management with conducting monitoring authorizations and ongoing assessments

Degree Requirements：

Bachelors or Masters degree required. Field of study within life sciences or equivalent.

Experience Requirements：

• Associate Clinical Trial Monitor: 1 year of relevant clinical research experience and/or relevant educational experience.

• Clinical Trial Monitor: 2-3 years of relevant clinical research experience, able to work independently.

• Senior Clinical Trial Monitor: At least 5 years of monitoring experience. Demonstrate leadership skill, mentor and coach capability.

• Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator preferred.

• Experience in the drug discovery/development process.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.