Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Worldwide Commercial Operations is the catalyst for empowering the field force to drive transformative customer experiences that give patients hope. The Worldwide Training Design & Development Team is part of the WW Training & Talent Development team, a dynamic training organization that is executing on excellence in building expertise and knowledge for our field force.  As a Manager on the Worldwide Training team, you will be working amongst the best in your profession and have the opportunity to collaborate with talented and dedicated people. 

What we are looking for:

Worldwide Training Design and & Development team is currently looking for a talented individual who possesses the skills needed to ensure both immediate and long-term success of the WW Training & Talent Development team.  The selected candidate will act as a strategic business partner across international markets to provide innovative and flexible training solutions that drive efficiencies and sharing of best practices. The Manager will be responsible for working directly with the local International training teams to ensure that the Oncology launch training strategy is implemented and aligned with the WW Training curriculum.

Who do you work with:

This Manager position reports to the Worldwide Training Associate Director who reports to the Vice President, WW Training & Talent Development team.  In this role, the Manager will work collaboratively across a fast paced and complex matrix organization, which includes the international Sales and Marketing teams and the international training colleagues to appropriately address business needs and ensure that we deliver on our objective of demonstrating value to our customers.

What are the primary responsibilities:

Launch Training Planning and Management

• Acts as a subject matter expert in Oncology to support the trainers in local markets for building launch plans, gaining access to and localizing training materials, developing expertise in Oncology.
• Identifies and communicates key launch market training needs
• Builds Oncology launch plans that leverage experience and resources from local markets to break silos between country trainers and drive efficiencies
• Facilitates virtual product training sessions for sales force new starters, that can be attended by multiple markets
• Works closely with local training teams to implement newly developed learning systems, run ‘train the trainer’ sessions, and demonstrate new workshop ideas and training elements
• Ensures that all training materials and delivery methods developed in the US are communicated and accessible on the internal SharePoint site

Training Solution Planning and Management

• Ensures that the account management strategy is woven into launch training process to further reinforce and embed initiatives and behaviors
• Develops and implements solutions to continue to build on strategic business partnering using adult learning principles
• Ensures that Oncology learning systems developed by the US are easily adaptable for use in the key launch international markets
• Identifies opportunities to develop capabilities and coaches local training team to standardize training execution worldwide
• Identifies new and innovative training techniques and works with the markets to implement where applicable
• Audits launch trainings in terms of learning effectiveness and cost effectiveness
• Coordination across the Oncology matrix and cross-functionally ensuring all training materials meet the goals and objectives of the International Sales and Marketing teams

• Partner with International training colleagues, Sales management, and Marketing management to consistently implement results-focused, performance-based, standardized training and development processes.
• Act as a liaison between international external vendors (i.e., training content developers) and internal personnel to ensure the successful design and roll-out of assigned training programs and projects

Qualifications:

• Bachelor’s degree or equivalent required; Master’s or Doctorate degree preferred
• Minimum of 10 years Pharmaceutical industry experience preferred
• Minimum of 3 years of Pharmaceutical training, preferable on a global scale
• Minimum of 2 years Oncology Training or Product Management experience required
• Ability to effectively communicate and interact with internal and external clients from all levels
• Demonstrated strength in facilitating discussions, presenting information and resolving issues
• Demonstrated high attention to detail, accuracy, timeliness and follow-through
• Strong project management experience with ability to set priorities, stay on schedule under tight timelines, and where change is both dynamic and a given
• Proven performance with a track record of meeting or exceeding goals
• Demonstrated ability to effectively manage multiple projects
• Problem solving and solutions oriented team player
• Effective communication and presentation skills
• Demonstrated organizational and project management skills
• Experience operating within a highly complex cross-matrix environment; ability to connect and collaborate with key matrix team members (International markets commercial teams,  International Training Team, WW Training team and local trainers)
• Ability to act as a leader and an active contributor, working effectively in the matrix culture
• Impact driven with high learning agility and keen ability to prioritize
• Proficiency in Microsoft Office Power Point, Excel and Word and other applications
• Ability to prioritize business needs and make timely decisions based on available data
• Ability to travel 50% of time
• This position will be based in the United Kingdom
• Valid passport required

Bristol-Myers Squibb is an equal opportunity employer - M/F/Vet/Disability

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Bristol-Myers Squibb Ireland

Bristol-Myers Squibb (BMS) has been in operation in Ireland since 1964, employing over 600 people across a range of activities and business units.

Located in Dublin, Cruiserath Biologics Campus, a one billion dollar Multi-Product Cell Culture Biologics Manufacturing facility, is part of the Global Product Development and Supply (GPS) network. This state of the art facility produces multiple therapies for the company’s growing biologics portfolio and plays a central role in Bristol-Myers Squibb global manufacturing network. The Global Biologics Laboratory (GBL), responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus.

BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work for 2017, 2018, 2019 and 2020. 

Many of the global business services, including Commercial, the European Treasury Centre, Global Bio Lab and Global Logistics are based on the island of Ireland. Ireland is also home to External Manufacturing’s global headquarters, the organization responsible for the management of manufacturing and reliable supply across the Bristol-Myers Squibb global network. This includes management of, and working in conjunction with, third party contract manufacturers and internal manufacturing sites.

The Role

BMS Cruiserath Biologics is seeking to recruit a Permanent Upstream Manufacturing Technology Engineer as part of Manufacturing Sciences and Technology (MS&T). The Upstream Manufacturing Technology group are responsible for process validation and continued process technical support to cell culture and primary recovery unit operations for the commercial manufacture of mammalian cell processes in the Multi Product Cell Culture facility at Cruiserath. The successful candidate will be key contributor to a dynamic and highly technical global team. This position will build collaborations with Manufacturing, Engineering, Quality Assurance, Quality Control and Global Regulatory Sciences groups.

Key Duties and Responsibilities:

• Supports commercial operations, process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for the Cruiserath Multi Product Cell Culture facility.
• Investigation and resolution of process deviations, root cause investigations, CAPAs, process improvements, change controls and preparation of regulatory filings.
• Strong knowledge of cGMP compliance, BMS corporate, site and regulatory agency requirements.
• Contributes to/Leads cross functional team (Manufacturing, QA, QC, Regulatory, Supply Chain, etc) for process improvement implementations, new product start-ups or other process changes at BMS-MPC facility
• Assists in evaluating process performance by comparing manufacturing data to historical data from other sites.
• Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process.
• Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the Cruiserath site.

Qualifications, Knowledge and Skills Required:

• Minimum BSc or equivalent with at least 4 years’ experience in upstream cell culture manufacturing technical support in the biopharmaceutical industry including experience with process validation.
• You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
• You have proven problem solving ability, project management skills, including leading cross functional teams and balancing multiple project assignments.

Please note that this role may require periods of extended hours or a modified work schedule and may require on-call availability.

What’s important to us

Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases:

Passion: Our dedication to learning and excellence helps us to deliver exceptional results.

Innovation: We pursue disruptive and bold solutions for patients.

Urgency: We move together with speed and quality because patients are waiting.

Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments.

Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.

Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential.

We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve.

Why you should apply

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days, life assurance, on-site gym and gain-sharing bonus.

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Short Job description

People Services HR Advisor is a member of the Human Resources organization, and is the primary contact for employees and managers, after MyLife.

The HR Advisor

• consults regarding the inquiry, works through options with the customer, and coaches through resolution;
• uses discretion and sound judgement to determine the best method of resolution;
• provides employees and managers with policy advice, guidance and support for workforce management, payroll, compensation transaction activities, and other HR processes; and
• engages appropriate functional and / or technical specialists to drive resolution of customer needs not resolved at first contact.

Job Description

• Where Direct Access was not sufficient, perform intake of HR inquiries via multiple channels including case systems, chat, email, and telephony.  Use discretion and independent judgement to advise the customer and determine best method of resolution.
• Provide employees and managers with policy advice, i.e. leaves of absence, new ways of work etc. as well as options to address issue. Guide manager on process for application of policy.
• Support execution of employee movement, employee status, payroll, benefits/leaves and compensation processes
• Guide employees and managers to available resources, eg toolkits or training materials developed by HR Expertise Teams, as appropriate
• Triage inquiry to ensure full understanding, and engage appropriate functional specialists to drive resolution of customer needs not resolved at first contact.
• Ensure accurate policy representation in interconnected systems/processes.
• Provides feedback to assist in developing client service improvement projects (e.g., knowledge base content updates, training/education of end users, improved Tier 1 communications, etc.).
• Demonstrate broad HR/Payroll knowledge, as pertains to the company, providing customers with relevant information, policy explanation and navigation support.
• Utilize knowledgebase and HR experience/ business understanding to interpret needs and resolve issues.
• Provide high touch customer service that meets expected service levels and business performance goals.
• Champion direct access processes by using change management skills to influence Managers and Employees.
• Support the integrity of employee records and Workday data, assuring legal and regulatory compliance.
• Prepare appropriate documentation to meet customer needs related to HR processes (can include change job letters, employee contract documents, severance letters, etc.).
• Ensure proper documentation of inquiries, root cause, and resolutions.
• Liaise with third party vendors as applicable to resolve customer inquiries.
• Works collaboratively within a team to share ideas, ownership, and accountability for driving improvements and consistency of execution for key HR processes.
• Identify and report any call trends or product trends to the Team Lead or Supervisor.
• Provide feedback on customer issues and the knowledgebase so that management can address and improve the items.
• Participate in scheduled and ad hoc training in order to improve policy and process acumen

Desired Experience & Skills

• Require college degree
• 2-5 years human resources operational experience
• General knowledge and understanding of HR policies, processes and Regional Employment Laws
• Have worked in a rapid, fast-moving environment, which is both complex and changing.
• Practical operational experience of HR processes, e.g., hire, payroll, benefits, performance
• Have worked in a multi-cultural/multi-country work environment
• Ability to use business judgment when assessing requirements and performance, in order to identify the right solution to meet business needs Previous experience working in a shared services environment preferred
• Prefer HR specialty certification to demonstrate theoretical understanding and application of HR practices

Desired Skills

• Language Requirements beyond English: Proficiency in at least one of the following languages: ideally, German but would consider French/ Italian/ Spanish
• Strong verbal and written communication skills to interact with clients and the HR function to deliver business needs.
• Ability to accurately assess situations through customer interactions in order to coach, guide, or interpret the appropriate action or next steps
• Demonstrated strong attention to detail
• Highly computer literate with knowledge

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Celgene (a wholly owned subsidiary of Bristol-Myers Squibb) is a global biopharmaceutical company committed to changing the course of human health through bold pursuits in science, life-enhancing therapies, and a promise to always put patients first. At the core of that mission are the talented individuals who contribute their unique skill sets to help us drive innovation and deliver truly life-changing drugs for our patients. As we continue to pursue that mission, we're looking for talented professionals like you to join our team.

The QA Operations team is committed to actively support Celgene International manufacturing site and other departments to ensure cGMP compliant production, testing and release of product on the Boudry manufacturing site.

In this role, you

• Ensure strong oversight between external partner and Boudry site about work-in-progress and release priorities using SharePoint, electronic system reporting and database
• Cover different types of administrative services (reception, compilation, scanning) of the dossier, and practical activities (e.g. handling of Samples, destruction…)
• Handle and prepare executed batch records and documents to make the dossiers ready for the review by QA Operations team, contact partners if necessary, to collect lacking documentation.
• May review Batch record as a support activity
• Work in close collaborations with QA function and other stakeholders (e.g. Manufacturing, QC, Supply Management, Customer Logistics)
• Ensure close collaboration with external partner to comply with Celgene’s Quality Operations roles, responsibilities and requirements as defined in the Quality Agreements to allow smooth, compliant and timeliness release of the products between both parties.
• Ensure scanning of the executed batch records and QA documentation regarding the given lead-times and due date
• Ensure registration of exBRs and documents into the shared drives, folders and database as required.
• Ensure the follow up of the QA documentation in the archive room as assigned.
• Ensure efficient management of the QA Operations archiving areas.
• Ensure preparation and update of the weekly planning of the executed batch records as requested.

Skills/Knowledge Required

• Professional certification in administrative field with minimum 1 year of administrative experience.
• At least 1 year of experience in a pharmaceutical company or other related industry.
• Strong knowledge in computer tools Microsoft (Access, Excel, Word) and scanner software.
• Ability to work independently, yet effectively in a team-oriented environment.
• Strong sense of responsibility, reliability, accuracy and timely work.
• Ability to handle multiple tasks while working against pressures of deadlines.
• Good organizational skills capability.
• Good written and verbal communication skills.
• Sense of team spirit, initiative and service

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Local Protocol Manager will provide end-to-end management of Non-Regulatory Data Generation (NRDG) clinical research in China. They will develop expertise in a disease area (oncology or speciality), and focus on studies including Health Economics and Outcomes Research (HEOR), Investigator-Sponsored Research (ISR), Expanded Access Programs (EAP), and some late-stage interventional research. Study managers act as a matrix leader for the Study Management Team and are accountable for the timely execution of NRDG.

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Engaging Medical Science Communicator:

BMS is recruiting for a Medical Science Liaison, Haematology to engage in compelling and insightful medical science interactions with Thought Leaders & HCPs concerning the company’s marketed and development pipeline of Haematology-Oncology therapies.

Responsible for the southern region territory inc. Vic, Tas, SA & WA, this is an externally facing role focused on mapping the medical science landscape and engaging HCPs in advanced medical science discourse regarding treatment and research issues. You will work collaboratively with Medical and enterprise colleagues, inc. Clinical Research Operations, Regulatory, Market Access and Marketing.

BMS is Australia's fastest growing biopharmaceutical company with an expanding portfolio of innovative medicines to treat serious unmet medical needs. We are committed to improving patient outcomes and the Medical Science Liaison, Haematology will perform a crucial role in enabling patient’s access vital medications.

Career Development, Rewards, Culture:

BMS is focused on developing employees and investing in you. Leaders work with you to define career development goals and facilitate access to new opportunities to broaden your experience, knowledge & skills.

BMS is committed to rewarding workers for great performance, ensuring individuals are compensated fairly for the work they deliver and how it is delivered.

BMS is proud to welcome new employees into a diverse, inclusive and innovative culture. We are diverse in every dimension: from gender to ethnicity, to experiences and skills. We believe inclusivity unlocks the power of diversity, leading to innovation that drives better outcomes for patients.

Responsibilities include:

Medical/Scientific Exchange

• Contribute to the development and execution of a Thought Leader/HCP engagement plan.
• Develop and maintain contacts with Thought Leaders, in accordance with the strategy
• Proactively and/or reactively interact with HCPs, as appropriate, by focusing on implementation of the tactical medical plan for the brand or disease area.
• Ensure appropriate response to unsolicited scientific questions or requests posed by HCPs for approved Products/Brands (in and off label), and for products in development.

Communicate Medical Insights

• Profile the medical landscape within the disease area and continuously update this knowledge, inc. expertise in products, patient treatment trends, clinical trials etc.
• Ensure awareness of current key topics and questions, and proactively contribute insights gained from healthcare provider interactions to the internal Medical teams.

Support Clinical Research

• Contribute to the identification of potential opportunities for participation in clinical development programs, by gaging interest, mapping centres of excellence, treatment trends and recruitment.
• Facilitate clinical trial activities with Investigators for both sponsored and supported trials, in accordance with the appropriate policies.

Compliance & Training

• Endorse and implement a culture of compliance - adhere to all internal and external guidance, rules and regulations
• Contribute to the initial and ongoing medical/scientific disease area and product-specific training of internal and field-based BMS personnel
• Prepare speakers by acting as a facilitator during formal Speaker Training meetings

Experiences, Skills & Qualifications:

• Demonstrable experience engaging and interacting in deep medical science discourse with HCPs
• Medical Doctor (MBBS, MD), PhD, Pharmacy or Biological Science qualifications essential
• Previous experience working as an MSL or in another HCP-facing role in pharma / biotech / medical tech preferred (e.g. Clinical Research, Sales, Marketing)
• Deep Haematology-Oncology medical science knowledge is strongly preferred
• Demonstrable ability to build effective relationships with internal and external stakeholders
• Strong communication skills, written and oral, and presentation skills.
• Knowledge of the drug commercialisation and clinical research process

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Test product, raw material, packaging material, intermediate, stability sample and standard, general method, Pharmacopeia, etc.

Record test procedure and lab activity, report test results following SOP

Maintain the instrument and complete other tasks assigned by supervisor.

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

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

BMSKK business targetをachieveするために最適な薬事戦略を立案・実行することにより、価値の高い新薬開発に貢献する。

そのために、最新の薬事規制に精通し、規制当局（医薬品医療機器総合機構／厚生労働省）とのコミュニケーションの質を向上させる。また、新薬開発における不測の事態に備えるために薬事的なリスク回避策を提案する。
 

役割 (Roles & responsibilities)

BMSKK assetのlife cycleの各段階において、主に以下の業務を行う。

開発段階：

• 新薬の開発計画に対して薬事の観点で適切なインプットを行い、適切な開発計画策定に貢献する。
• 治験計画が問題無く当局に受理され、計画どおり治験が開始できるよう開発チームに貢献する。
• 治験相談の必要性を判断する。必要と判断された場合、提案する開発計画が当局に受け入れられるような治験相談の戦略を作成する。
• 薬事的なリスクを特定し関係者に共有し、適切な時期にリスク最小化もしくは回避策を関係者と提案・協議する。
• 治験計画届や治験相談時の照会事項回答が期限内に提出でき、かつ追加照会を受けないレベルの、質の高い回答になるよう適切な提言を行う。
• 薬事戦略の作成に関しては、常にGRTLとalignし、GRTL・Globalの関係部署との適切な連携を図る。

承認申請・審査段階：

• オーファン・優先審査等の指定に向け必要な作業をリードする。
• 申請資料作成タイムラインに従い、計画通りに承認申請できるようJNDAチームをリードする。
• 申請前相談の必要性を判断する。必要と判断された場合、提案する開発計画が当局に受け入れられるような申請前相談の戦略を作成する。
• 審査期間に影響が出ないように照会事項回答を適切な時期に提出できるようにチームを管理する。承認審査で発生するリスクは早期に特定して解決策あるいは代替案の準備をリードする。
• 承認審査に関する方針や進捗に関しては、常にGRTLとalignし、GRTL・Global関係部署との適切な連携を図る。

Regulatory Strategy Senior Manager (D6)に求められる業務範囲（Responsibilities）は以下のとおりである。

担当品目の薬事戦略について、cross functional teamにて薬事的なdiscussionをリードしチームをサポートする。D5、D4の指導を行う。

• 社内的影響力                               薬事エクスパートとして専門的なアドバイスができる
• 社外的影響力                               規制当局の主担当者との議論をリードすることができる
• グローバルへの影響力               上長の指導・補助を得ながら、Global Regulatory Strategy Group Directorと、担当Disease Areaの
                                         業務をすすめることができる
• 薬事業務のレベル       Regulatory Strategy, HA interaction Strategyに対するリスク・自/他部門のビジネスインパクトを
                                         分析することができる

必要な知識/スキル (Required knowledge/skills)

• 必要な知識   上述の業務を円滑に行うための業界における最新の薬事知識、及び新薬開発業務に関する経験
• 必要なスキル        ビジネスに求められる一般的なコミュニケーション、プレゼンテーション、ストラテジックシンキング、

                                ネゴシエーション、リーダーシップ、問題解決能力、及びコーチングスキル
                                英語によるコミュニケーションスキル（OPA: 6.5）

High-level description; including manage team/individuals or not
Contribute to developing valuable new drugs by providing and implementing optimal regulatory strategy in order to achieve BMSKK business target. For that objective, have a deep knowledge of up-to-date regulatory affairs and improve the quality of communication with regulatory authorities (PMDA/MHLW). In addition, provide mitigation plans for regulatory risks in order to deal with unforeseen situation in the development of new drugs.
 

Roles & responsibilities
Play following roles and take responsibilities at each phase in the life cycle of the BMSKK asset;
Development stage:

• Provide appropriate input from a regulatory perspective to the new drug development plan, and thereby contribute to prepare an appropriate development plan.
• Contribute the development team in order to ensure that the J-HAs (PMDA, MHLW) accept clinical study plans and the clinical studies are initiated as planned.
• Decide whether J-HA interactions (PMDA consultation, Preliminary meeting etc.) are needed. When it is decided that a J-HA interaction is needed, prepare a consultation strategy to ensure that the proposed development plan is accepted by the J-HA.
• Identify the regulatory risks and notify all relevant colleagues of these risks, and propose risk minimization or mitigation plans and discuss them with relevant personnel in a timely fashion.
• Provide appropriate advice to ensure that query responses related to CTNs and/or JNDA/sJNDA filing can be submitted within the deadlines, and to ensure that the responses submitted are high-quality responses that will not provoke additional queries.
• Collaborate with the GRTL regarding the preparation of the regulatory strategy, and keep good relationship and well communication with all relevant GRTL/Global team colleagues.

Approval application/review stage:

• Take the lead on the work that is required to obtain, for example, Orphan drug or Priority review designations.
• Lead the JNDA team to complete the JNDA/sJNDA filing as planned in accordance with preparation timeline of approval data.
• Determine whether a pre-JNDA consultation should be held. If it is determined that a pre-JNDA consultation is needed, then prepare consultation strategies to ensure that the regulatory authorities accept proposed development plan.
• Manage teams in order to submit query responses in a timely manner without having impacts on application period. Identify problems at an early stage during the JNDA/sJNDA review and lead the preparation of either resolutions or alternative plans.
• Collaborate with the GRTL regarding the JNDA/sJNDA review plans and progress, and maintain good relationship and well communication with all relevant GRTL/Global team colleagues.

Required level of responsibilities of Regulatory Strategy Senior Manager (D6) are as follows;
Lead regulatory discussions regarding the regulatory strategy for the product in charge with cross-functional teams and support them. Mentor D5 and D4.

• Level of influence inside the company: Can provide professional advices as a regulatory expert.
• Level of influence outside the company: Can lead discussions with J-HA officers.
• Level of influence globally: Can collaborate with the Global Regulatory Strategy Group Director and move the work forward in the assigned disease area under the instructions/support from his/her report line.
• Regulatory work level: Can analyze the risks and the business impact on his/her own department and other departments of regulatory and J-HA interaction strategies

Required knowledge/skills

• Required Knowledge: Up-to-date regulatory knowledge required to do the job as described above, and experience with new drug development work.
• Required Skills: Good communication skill, good presentation skills, good strategic thinking ability, good negotiation skills, good leadership skills, good problem-solving ability, good coaching skills, and OPA: 6.5

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

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

BMSKK business targetをachieveするために最適な薬事戦略を立案・実行することにより、価値の高い新薬開発に貢献する。

そのために、最新の薬事規制に精通し、規制当局（医薬品医療機器総合機構／厚生労働省）とのコミュニケーションの質を向上させる。また、新薬開発における不測の事態に備えるために薬事的なリスク回避策を提案する。
 

役割 (Roles & responsibilities)

BMSKK assetのlife cycleの各段階において、主に以下の業務を行う。

開発段階：

• 新薬の開発計画に対して薬事の観点で適切なインプットを行い、適切な開発計画策定に貢献する。
• 治験計画が問題無く当局に受理され、計画どおり治験が開始できるよう開発チームに貢献する。
• 治験相談の必要性を判断する。必要と判断された場合、提案する開発計画が当局に受け入れられるような治験相談の戦略を作成する。
• 薬事的なリスクを特定し関係者に共有し、適切な時期にリスク最小化もしくは回避策を関係者と提案・協議する。
• 治験計画届や治験相談時の照会事項回答が期限内に提出でき、かつ追加照会を受けないレベルの、質の高い回答になるよう適切な提言を行う。
• 薬事戦略の作成に関しては、常にGRTLとalignし、GRTL・Globalの関係部署との適切な連携を図る。

承認申請・審査段階：

• オーファン・優先審査等の指定に向け必要な作業をリードする。
• 申請資料作成タイムラインに従い、計画通りに承認申請できるようJNDAチームをリードする。
• 申請前相談の必要性を判断する。必要と判断された場合、提案する開発計画が当局に受け入れられるような申請前相談の戦略を作成する。
• 審査期間に影響が出ないように照会事項回答を適切な時期に提出できるようにチームを管理する。承認審査で発生するリスクは早期に特定して解決策あるいは代替案の準備をリードする。
• 承認審査に関する方針や進捗に関しては、常にGRTLとalignし、GRTL・Global関係部署との適切な連携を図る。
   

Regulatory Strategy Manager (D5)に求められる業務範囲（Responsibilities）は以下のとおりである。

担当品目の薬事戦略について、cross functional teamにて薬事的なdiscussionをリードしチームをサポートする。重要な業務を行う際は、Directorへの事後の報告が必要。

• 社内的影響力                               プロジェクトメンバー間の意見調整を行うことができる
• 社外的影響力                               規制当局の主担当者と意見調整のため議論ができる
• グローバルへの影響力               GRTLと業務をすすめることができる
• 薬事業務のレベル       Regulatory Strategy, HA interaction Strategyを作成・リードすることができる
   

必要な知識/スキル (Required knowledge/skills)

• 必要な知識   上述の業務を行ううえで必要な開発薬事の知識（新薬開発・承認申請業務に必要な通知・ガイドライン等）
                         また、新薬開発業務に関する経験が必要
• 必要なスキル        ビジネスに求められる一般的なコミュニケーション、プレゼンテーション、ストラテジックシンキング、

                                ネゴシエーション、リーダーシップスキル、問題解決能力
                                英語によるコミュニケーションスキル（OPA: 6.0）

High-level Description; including manage team/individuals or not
Contribute to developing valuable new drugs by providing and implementing optimal regulatory strategy in order to achieve BMSKK business target. For that objective, have a deep knowledge of up-to-date regulatory affairs and improve the quality of communication with regulatory authorities (PMDA/MHLW). In addition, provide mitigation plans for regulatory risks in order to deal with unforeseen situation in the development of new drugs.

Roles & Responsibilities
Play following roles and take responsibilities at each phase in the life cycle of the BMSKK asset;
Development Stage:

• Provide appropriate input from a regulatory perspective to the new drug development plan, and thereby contribute to prepare an appropriate development plan.
• Contribute the development team in order to ensure that the J-HAs (PMDA, MHLW) accept clinical study plans and the clinical studies are initiated as planned.
• Decide whether J-HA interactions (PMDA consultation, Preliminary meeting etc.) are needed. When it is decided that a J-HA interaction is needed, prepare a consultation strategy to ensure that the proposed development plan is accepted by the J-HA.
• Identify the regulatory risks and notify all relevant colleagues of these risks, and propose risk minimization or mitigation plans and discuss them with relevant personnel in a timely fashion.
• Provide appropriate advice to ensure that query responses related to CTNs and/or JNDA/sJNDA filing can be submitted within the deadlines, and to ensure that the responses submitted are high-quality responses that will not provoke additional queries.
• Collaborate with the GRTL regarding the preparation of the regulatory strategy, and keep good relationship and well communication with all relevant GRTL/Global team colleagues.

Approval Application/Review Stage:

• Take the lead on the work that is required to obtain, for example, Orphan drug or Priority review designations.
• Lead the JNDA team to complete the JNDA/sJNDA filing as planned in accordance with preparation timeline of approval data.
• Determine whether a pre-JNDA consultation should be held. If it is determined that a pre-JNDA consultation is needed, then prepare consultation strategies to ensure that the regulatory authorities accept proposed development plan.
• Manage teams in order to submit query responses in a timely manner without having impacts on application period. Identify problems at an early stage during the JNDA/sJNDA review and lead the preparation of either resolutions or alternative plans.
• Collaborate with the GRTL regarding the JNDA/sJNDA review plans and progress, and maintain good relationship and well communication with all relevant GRTL/Global team colleagues.

Required level of Responsibilities of Regulatory Strategy Manager (D5) are as follows;
Lead regulatory discussions regarding the regulatory strategy for the product in charge with cross-functional teams and support them.
Report to the director after the action when he/she conducts the important tasks.

• Level of influence inside the company: Can facilitate the discussion to arrive at a consensus among project members.
• Level of influence outside the company: Can engage in discussions with J-HA officers.
• Level of influence globally: Can collaborate with the GRTL and move the work forward.
• Regulatory work level: Can prepare and take the lead on regulatory and J-HA interaction strategies.

Required Knowledge/Skills

• Required Knowledge: The development regulatory knowledge required to do the job as described above (necessary notification of new drug development and approval application, guidelines etc.) and experience with new drug development work
• Required Skills: Good communication skill, good presentation skills, good strategic thinking ability, good negotiation skills, good leadership skills, good problem-solving ability, and OPA: 6.0

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

概要 (High-level Description; including manage team/individuals or not)
JEDT/JFDT もしくはJNDA team に参画し、Regulatory Documentの作成においてをRegulatory Strategy Lead及びプロジェクトチームをサポートする。最も効率的なプロセス・方法を提案し、より最適な承認取得・開発計画立案・経験の構築に寄与する。

役割 (Roles & responsibilities)

• 新薬の開発開始から承認取得までの開発薬事全般業務に関与する。
• 品質の高い申請資料の作成をサポートし、最も効率的なプロセス・方法を提案する。
• 規制当局提出文書（CTD、治験相談資料、CTN関連文書 等）のsubmission ready complianceを担保する。
• 全ての申請業務においてPMDAへの資料提出作業をリードする。
• 規制当局との会議（対面助言、初回面談等）に際し、Regulatory Strategy Leadと協力し、必要な文書作成をサポートする。
• 規制当局からの照会事項回答作成に際し、Regulatory Strategy Leadと協力し、回答文書の作成をサポートする。
• GRSB Global Dossier Management teamと協力し、J-CTDのTOC作成・管理を行う。
• Regulatory ITと協力し、BMSKKでのPublishing / Authoring tool導入、Training及び業務processの改善を行う。
• 業界活動等を通じ、提出文書や、文書提出方法の規制要件に関する最新情報を常に把握し、効率的なアイデアを提案する。
• グローバルの担当者との円滑なコミュニケーションにより、提出文書の規制要件に関する最新情報や問題点・リスクをお互いに共有し合う。
• 外部ベンダー（eCTD vendor、印刷業者、翻訳業者等）との契約・折衝を担当し、最適なoutsourcingを提案・実施する。
• 薬事関連文書の保管を行う。
• 治験薬概要書(和訳)作成に関して適切なProcessを担保し、IB-Coordinatorをサポートする。

Regulatory Coordinator Manager (D5)に求められる業務範囲（Responsibilities）は以下のとおりである。
担当品目の申請資料作成業務についてdiscussionをリードしチームをサポートする。業務量と必要なリソースの見積もり、業務プロセス最適化の方策を提案する。重要な業務を行う際は、Directorへの事後の報告が必要。

• 社内的影響力：プロジェクトメンバー間での意見の調整を行うことができる
• 社外的影響力：規制当局担当者、Vendorと意見調整のため議論ができる
• グローバルへの影響力：GRTLとGRSMとSubmission Operation, Content Authoringの strategyを議論できる。Regulatory ITとPublishing / Authoring toolやprocessに関して技術的な議論ができる。
• 薬事業務のレベル：Submission Operation, Content Authoringのstrategyを開発チームと協議し作成することができる、 また、進捗に応じ適宜、修正していくことができる。

必要な知識/スキル (Required knowledge/skills)
必要な知識 上述の業務を行ううえで必要な開発薬事の知識（新薬開発・承認申請業務に必要な通知・ガイドライン等）
必要なスキル ビジネスに求められる一般的なコミュニケーション、プレゼンテーション、ストラテジックシンキング、 ネゴシエーション、リーダーシップスキル、及び問題解決能力 英語によるコミュニケーションスキル（OPA: 5.5）

High-level description; including manage team/individuals or not
Take part in the JEDT/JFDT or JNDA team, and support the Regulatory Strategy Lead and project teams to prepare regulatory documents. Propose the most efficient processes/methods, and contribute to optimal approval, development planning, and gaining experience.

Roles & responsibilities

• Engage in overall regulatory affairs work, from the start of new drug development through to approval.
• Support the preparation of high-quality application documents, and propose the most efficient processes/methods.
• Guarantee the submission ready compliance of documents submitted to the regulatory authorities (e.g., the CTD, PMDA consultation documents, CTN related documents).
• Lead the document submission operation to Japanese regulatory authorities.
• Work with the Regulatory Strategy Lead and support the preparation of the required documents for meetings with the regulatory authorities (e.g., PMDA consultations, interview meetings).
• Work with the Regulatory Strategy Lead and support the preparation of the required documents when preparing responses to queries from the regulatory authorities.
• Work with the GRSB Global Dossier Management Team to prepare and coordinate the J-CTD TOC.
• Work with Regulatory IT to introduce publishing/authoring tools/training at BMKK and improve working processes.
• Constantly obtain, through industry activities, etc., the most up-to-date information about the regulatory requirements for document submission and for document submission methods and propose efficient ideas.
• Stay in close contact with global staff and share the most up-to-date information about the regulatory requirements for document submission and about any problems or risks.
• Take responsibilities for negotiating/making contract with external vendors (e.g., eCTD vendors, print vendors, translation vendors) and for proposing and implementing optimal outsourcing.
• Archive regulatory affairs-related documents.
• Assuring appropriate process for translating IBs into Japanese and support IB-Coordinator.

Required level of responsibilities of Regulatory Coordinator Manager (D5) are as follows;
Lead the discussion regarding the preparation of application documents for the projects and support teams. Estimate the workload and required resources. Propose work process optimization. Report to the Director after the important actions.

• Level of influence inside the company: Can coordinate opinions among project members to reach a consensus.
• Level of influence outside the company: Can engage in discussions in order to reach a consensus with regulatory authority staff and vendors.
• Level of influence globally: Can hold discussions with GRTL and GRSM about submission operation and content authoring strategy. Can hold technical discussions with Regulatory IT about publishing/authoring tools and processes.
• Regulatory work level: Can work with the development team to prepare submission operation and content authoring strategies. Can revise them as appropriate depending on the situation.

Required knowledge/skills

• Required knowledge: The development regulatory knowledge required to do the job as described above (necessary notification of new drug development and approval application, guidelines etc.)
• Required skills: Good communication skills, good presentation skills, good strategic thinking ability, good negotiation skills, good leadershipskills, good problem-solving ability, and OPA: 5.5

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 the resources to pursue their goals, both at work and in their personal lives.