Astellas Pharma jobs - 158 jobs

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: Coordination and execution of work within the Site Contract, Budget support function in support of both early and late-stage Clinical Operations and may include support for other functions (Medical Affairs). This position is responsible for the establishment and maintenance of global best practices as it relates to applying the relevant regulatory, legal requirement and global data privacy requirements in the support of clinical trial execution that adhere to Astellas and GCP/ICH requirements. This position will collaborate with Astellas Legal/Data Privacy Organizations, Ethics & Compliance and other external stakeholders as required. This position will contribute to project level timelines and will report on performance timelines both during feasibility and throughout the lifecycle of contract/budget negotiation. This position is accountable for the efficient delivery of core and country templates for clinical site operational documents that maintain regulatory and corporate compliance, operational and legal standards, while ensuring contracts are delivered to meet study/project timelines. This position may be responsible for managing direct reports and may additionally include oversight of contractors. Responsibilities and Accountabilities: Responsible for development of final processes, standards and tools for utilization within either both Site Contracts and Site Budget or a specific area of focus (e.g. Site Contract or Site Budget, including global implementation with the project team. Draft of guidance documentation(s) and training. Manages the changes of the documents, templates or training under their purview. Serves as primary liaison to collaborate between business and designated legal partners (as needed) to support development of global templates and processes to help ensure timely, proactive, strategic, best-in-class legal advice and support, taking into account objectives of the organization, and the unique and varying global, regional and local legal and regulatory requirements in a risk-balanced manner in order to effectively minimize and mitigate risk to the business. Participates in strategic improvement/innovation projects as requested. Responsible for the preparation and management of functional budgets and resources and oversight of related components of trial budgets and timelines and resources for all clinical studies related to these positions. Support for Industry Best Practice investigation and implementation. Support for development of related metrics for functional area, including measurement, and monitoring including recommendations to enhance performance of study start up. Management of any CRO resources necessary for study delivery.

The Manager, LMS Operations & Administration position works as part of the U.S. Ethics & Compliance Training & Documentation team to lead all components of our Learning Management System (LMS) including all non-GxP assignments and audience management, curriculum management, reporting, and tier one trouble shooting. The Manager, LMS Operations & Administration will partner with all levels of Management in both business and technology groups to advance and deliver a variety of planned and ad-hoc training initiatives. This position will have direct oversight of two Contracted Workers. **** + Responsible for the operational oversight of all LMS activities including but not limited to: + Partner with internal LMS Support Team to perform needs assessments and analysis on platform operations to ensure organizational needs are being met. Leads the incorporation, socialization, and training of resulting LMS improvements. + Owns all non-GxP LMS usage workflows and processes with business owners for suitability/fit; suggests and implements alternatives as needed + Regularly perform reviews of existing training curricula, identify gaps in course assignments and implement necessary changes. + Create, maintain, and run scheduled as well as custom reports, in a timely manner, as designated for analysis and decision making. Create new reports as requested. + Assist in managing external vendors, suppliers, and internal business partners as needed with a continuous improvement mindset. + Partner across departments as necessary to initiate timely and compliant learning initiatives + Continually enhance our methods and materials based on best practices in the industry, emerging technologies, vendor resources and products, business unit requirements and expectations, and feedback from customers, trainers and associates. + Ensure operational alignment across OAPI/OPDC learning community + Develop and deliver LMS platform training when required. + Oversee the work of two remote-based contracted resources. + Represent Field Training and Development's unique needs at governance and committee meetings/working groups **Qualifications/ Required** Knowledge/ Experience and Skills: + Bachelors degree in related field, or equivalent experience and demonstrated skills and abilities + 5+ years of Learning Management System (LMS) experience + Advanced working knowledge of LearnShare LMS + Understanding of current approaches in applying technology in learning solutions and experience implementing e-Learning and web-based programs. + Strong technical acumen; proficiency in Microsoft Office 365, SCORM; experience with Tin Can/xAPI, LRS's, and general technical troubleshooting + Ability to work in a fast-paced environment and be comfortable with consistent change + Detail-oriented with strong organizational skills + Strong written and verbal communication skills + Ability to prioritize and manage multiple responsibilities at once + Positive can-do attitude; always willing to learn + Strong analytical/technical skills + Comfortable with data management/data manipulation + Resiliency and tolerance of ambiguity **Preferred:** + Experience in pharmaceuticals/medical devices or other regulated industry + Embody a customer service mentality as you communicate and support field sales teams + Experience leading Contract Workers remotely Educational Qualifications + Bachelors degree in related field, or equivalent experience and demonstrated skills and abilities **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $104,640.00 - Maximum $156,400.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Compensation Data Compensation: This position offers a base salary typically between $140,000 and $219,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. Description As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Senior Associate Director, National Acct and Sales Retail is responsible for the management of the assigned Customers and account managers. The incumbent will develop the retail strategy for their relevant channel of assigned customers, and the implementation of the Boehringer sales/marketing plan to assure maximum distribution and market penetration of Boehringer products. Responsibilities for this role include achieving net sales, profit, and market share goals, and delivering against customer KPIs. The incumbent will manage a team of account managers, across relevant portfolio of customers. This role will support the leadership of the sales functional by developing key internal relationships, as well as external. This position has responsibility for key additional projects which support the continued development and future strategy of the sales organization. Remote based role. Locations: Duluth, GA or Seattle, WA Duties & Responsibilities Works with and through assigned customers and Key Account Managers to ensure sales performance meets or exceeds annual Company sales and market share objectives. Implements a sales strategy to be executed through their relevant channel and Key Account Managers. Exercises fiscal control on allocated operating budgets across multiple customers. Manages across multiple customers. Responsible for setting of annual KPIS. Works to improve to sales bench of the organization, with the Head of Sales. Utilizes appropriate data sources to develop tactical plans and to develop future customer / channel strategy. Actively monitors progress of work, cross-functional activities, and accountability. Plans and executes meetings that effectively implement objectives and strategies as determined by the Company. Spends appropriate amount of time developing customers, networks, and their relationships to foster Company business. Leads the senior customer engagement strategy across the channel, ensuring relevant T2T, strategic customer meetings and line reviews are delivered. Develops positive relationships with Company internal customers, such as supply, marketing, Segment Leads. Performs all Company business in accordance with all regulations (e.g., EEO, FDA, OSHA, etc.) and Company policies and procedures. Demonstrates high ethical and professional standards with all business contacts to maintain BIAH's excellent reputation within the community. Leads special strategic projects as relevant, which will ensure future success of the retail sales team. Requirements BS/BA. Minimum of eight to ten (8-10) years successful commercial industry experience. Minimum of five to seven (5-7) years retail experience, across Omni channel, ideally in US Mass market, E-commerce, or Retail Pharmacy. Understanding of retail analytics, economics, supply chain, and consumer insights. Understanding of the digital environment, e.g., E-Commerce and digital marketing. Understanding of the US retail environment. Experience in working cross-functionally. Project Management Skills. Proficiency in Excel, Word, Outlook, PowerPoint, and database applications. Ability to travel. Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older.

**Customer Engagement Model** Otsuka America Pharmaceutical, Inc. has launched a new customer engagement approach designed to better deliver on patient, caregiver, and HCP needs in an evolving healthcare environment. The new model is built around where patients get their care-locally, with the intent to better serve patients, caregivers, and healthcare providers, delivering a higher quality experience that ultimately is focused on improving patient care. The local "ecosystem approach" creates a unified focus among account management, medical, patient access and market access to engage local healthcare systems and identify opportunities to improve the patient experience. Through this matrix model, customers will now experience more coordinated and seamless care with digital-enabled support to bridge care gaps. In Otsuka's evolved customer engagement model, a Health Science Associates (HSA) will engage HCPs through a variety of in-person, virtual and digital tools, offering expanded expertise regarding products and the approved conditions they treat. Otsuka's Clinical & Scientific Liaison (CSL) will provide deep clinical expertise on-demand and will engage healthcare providers to offer personalized education on disease state, thought leadership and real-world evidence. A Patient Education Liaison (PEL) works to inform, educate, and enhance the experience of patients throughout their care continuum. The HSAs are led by Ecosystem Leads and grouped into regional areas. Ecosystem Leads are led by Regional Leads with significant autonomy to assess unique market priorities and customize decisions that reflect local customer needs. In the future, Otsuka will also be shifting to a team-based approach to drive customer engagement quality, accountability, and cohesion around patients and healthcare providers. Ultimately, it is all about putting customers at the center of everything they do. **Position Overview** **- Medical** **Science Liaison** **(Senior Manager)** As an integral member of the ecosystem team for Otsuka's new ecosystem-based customer engagement model, the Medical Science Liaison (MSL), Sr Mgr contributes to the development of the ecosystem strategic business plan and identifies key stakeholders that are vital to the ecosystem. The Medical Science Liaison (MSL) is a credible partner responsible for providing clinical, scientific and health economic information related to disease states and the appropriate utilization of approved Otsuka products within an ecosystem. This field-based position will engage with Key Influencers (KIs), Local Practice Leaders (LPLs), healthcare providers, and patients' groups within their ecosystem, to further patient outcomes aligned with the overarching objectives of Otsuka. In collaboration with their ecosystem partners, CSLs contribute to the customization of the region business strategy to meet local ecosystem needs and are responsible for the medical and educational requirements of their customers. In addition, CSLs may be responsible for covering multiple products within a therapeutic area, as well as engaging in broad clinical and scientific discussions that impact patient care, resulting in rich customer insights shared within the ecosystem. **There are 2 positions available** **Key Activities and Responsibilities** + As part of the ecosystem team contributes a clinical and scientific perspective to the local execution plan that addresses ecosystem, and customer challenges, issues, and opportunities, to bring about improved patient care and outcomes. This extends to include coordination around execution of field activities. + Build, cultivate, and leverage external relationships with key scientific and medical customers and organizations within their ecosystem to ensure strong understanding of evolving healthcare trends, disease state, Otsuka products, systems, and services across the ecosystem landscape, including KIs, LPLs, Key Decision Makers (KDMs) and Patient Advocacy. + Maintain a comprehensive understanding of the ecosystem to ensure alignment with Otsuka's patient-centric strategy and priorities, including provision and delivery of optimal patient care. + To be a credible source of evidence-based information that demonstrates the value of Otsuka and its products from the clinical, economic, and humanistic standpoint and works in partnership with providers, payers, and other key stakeholders to apply practical real-world solutions to improve patient outcomes. + Build and cultivate important internal working relationships across the matrix team to ensure an enterprise approach when working with customers. Be accountable to regional Field Medical Affairs leadership to shape and execute on local medical strategies within planned timelines. + Actively contribute to planning, content development, and dissemination of disease state information to customers in the field on a regular basis using the remote customer engagement platform. + Disseminate disease state and healthcare landscape information to customers in the field on a regular basis utilizing remote customer engagement platform. + Responsible for delivering the training and evaluation of promotional and disease state speakers. + Serve as part of Otsuka's internal speaker bureau in support of product educational needs across the ecosystem. + Collect and submit medical insights that drive decision making and prioritization of evidence generation efforts and healthcare solutions, including sharing at the local ecosystem level. + Assist with Otsuka's clinical trials program, including registrational, post-marketing and Investigator-Sponsored Trials (ISTs), health economic outcomes research, other specific medical collaborations; provide clinical expertise and feedback regarding operational management of clinical trials to ensure optimal site selection and performance. + Support other areas of the organization including Safety & Pharmacovigilance for investigation of safety-related issues, Sales Training medical education on an ongoing basis including new hire and POAs, and the Field Medical Center of Excellence for mentoring and sharing of best practices. **Qualifications** + Advanced degree in Pharmacy, Medicine, Biological Sciences, Health Services Research or Public Health, (PharmD., M.D., PhD. or D.Ph.) is required. + Relevant therapeutic area knowledge is required. + Understanding of the interconnectivity of health systems, overall delivery of patient care and experience working with healthcare professionals and other decision makers. + Minimum of 3-5 years related work experience (clinical, health system or industry) + Outstanding business acumen; knows the industry, Otsuka's business model and value proposition, key competitors, and other marketplace factors/dynamics. Able to identify solutions with the overall goal of improved patient outcomes. + Excellent communication and collaboration skills; exhibits professional maturity, confidence, and competence. Strong conflict resolution skills: proven ability to achieve conflict resolution effectively and quickly with affected parties and work in a cross-functional environment. + Knows how to summarize and communicate complex information and business objectives in a concise and effective way during presentations and other interactions. + Understanding of industry legal, regulatory, and compliance landscape + Ability to work in an ambiguous environment undergoing transformation. + Demonstrates behaviors aligned with the Otsuka Corporate Brand including Perseverance, Unconventional Thinking, and Humility. + Business travel, by air or car, up to 70% of time depending upon size of ecosystem. + Preferred living location is key city in ecosystem. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. As an Associate Director, Biostatistician, you will be a champion of Otsuka's culture and values and will be responsible for providing statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical role in the development of protocols and statistical designs in different phases of the clinical trials leading to approval of drug products in different phases of the clinical trials. This position can be based in Princeton, New Jersey, or Rockville, Maryland. Remote arrangements can also be considered. Otsuka maintains a hybrid work policy and travel is expected 20% of the time based on business needs. You will report to the Senior Director, Biostatistics. **** + Provides statistical analysis plan, including study design, sample size, primary and secondary endpoints, and statistical analysis method in protocol development + As core study/project team member, provide statistical input in different perspective of the clinical trial conduct such as CRF review, IRT setting, DMC set up, annual reports and PSUR + Develops Statistical Analysis Plan (SAP) and mock TFLs for interim or final analyses + Participate strategic planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages. + Support statistical needs for market access and publications. + Core team of developing final study report (FSR), including authoring statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, FDA issues, and general drug development. + Reviews clinical, statistical, and regulatory literature for current clinical trial results, regulatory trends and new statistical methods to be applied on his/her assigned therapeutic area. + Attend FDA meetings, FDA advisory boards, or other scientific meetings. + Serves as the Biometrics Trial Lead (BTL) in the project team and provides expertise and input regarding the statistical analysis, TFLs format and data collection and quality, and overall timeline. + Provides technical supervision over other biostatisticians assigned to his/her therapeutic area and assigns them the statistical tasks. + Takes full responsibility in managing biostatistical tasks (as listed above) for one therapeutic area and provides strategic technical support to other clinical projects. + Provides technical direction to supporting statisticians working on projects on a day-to-day basis. **Qualifications/ Required** **Knowledge/ Experience and Skills:** + Understands the company's products, the competition, and the pharmaceutical industry in general. + Demonstrates a competent knowledge of the company's work tools, processes, and policies. + Maintains a current awareness of new drug developments and statistical methodologies in the business. + Requires a strong working knowledge of applicable U.S. regulatory requirements and NDA preparation for submissions. + Effective communications within biostatistics function and with study team and key stakeholders across different functional areas such as clinical, regulatory affairs, asset management, safety and clinical operation. + Familiar with regulatory submission process in US and EU. **Skills** + In-depth knowledge of statistical principles, applications, and SAS/R programming software. + Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + Knows how/when to apply organizational policy or procedures to a variety of situations. **Educational Qualifications** + PhD or Master's degree in Statistics or Biostatistics. + Minimum 7 years (PhD) or 9 years (master degree) of experience in the pharmaceutical industry Experience in CNS area is a plus. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Executive Director, Field Enablement leads the strategy, execution, and continuous optimization of field systems, training and development, logistics, and HCP engagement operations that support sales force effectiveness. This leader oversees four core functional areas: 1) Field Technology - CRM, field reporting, and mobile tools, 2) Field Enablement - Fleet, sample operations, and territory alignment, 3) HCP Program Operations - Speaker Bureau, advisory boards, and congress support, and 4) Field Training and Development - Field Sales and Market Access Training, Field Leadership Capabilities, and Instructional Design & Learning Technology. The Executive Director partners closely with Field Strategy & Operations, Sales and Market Access Leadership, Medical Affairs, Brand Teams, and People and Business Services to ensure all tools, processes, program offerings, and infrastructure are aligned with business priorities and compliance expectations. This role leads a high-performing team to drive scalable, field-focused solutions across the commercial organization Key Responsibilities **Strategic Field Enablement Leadership** · Translate commercial strategy into practical, scalable systems, training and development programs, and services that support field execution. · Partner with Field Strategy & Operations on CRM enhancements, territory planning, and field optimization efforts. · Drive alignment and integration across field enablement, brand teams, s, Sales, Market Access, and other key enabling functions and cross-functional partners · Developing and leading effective training and development solutions and programs for commercial field employees, including sales leadership capabilities in partnership with People and Business Services **Functional Oversight** · Field Technology: Lead vision and enhancements for Veeva CRM, field dashboards and reporting, and mobile platforms. · Field Enablement: Ensure efficient, compliant execution of fleet operations, sampling processes, and territory alignments. · HCP Program Operations: Oversee strategy and execution of Speaker Bureau, advisory boards, and congress logistics, through direct leadership of the Associate Director, HCP Program Operations. · Field Training and development: Overseeing strategy and execution of Field Sales and Market Access Training, Field Leadership Capabilities, and Instructional Design & Learning Technology **Cross-Functional Collaboration & Compliance** · Collaborate with Sales, IT, Medical, Compliance, Legal, and Marketing to align on systems, engagement standards, and risk mitigation · Maintain audit-ready documentation, SOPs, and metrics for all field and HCP-facing operations. · Serve as a key stakeholder in governance efforts related to HCP interactions and field infrastructure. **Team Leadership & Development** · Lead a team of senior professionals across each functional area, fostering collaboration and accountability. · Build capabilities and talent pipelines to support current needs and future growth. · Promote a culture of operational excellence, innovation, and service to the field. **Change Management & Adoption** · Drive planning and rollout of new systems, processes, and operational models. · Deploy Training to ensure field teams are prepared and supported through change. · Leverage feedback and data to inform improvements and ensure adoption across teams. **Qualifications & Experience** **Required** : · Bachelor's degree in Business, Operations, or related field · 12+ years of experience in field operations, commercial systems, or HCP program management · Proven track record leading field-facing functions across large, matrixed organizations · Expertise in Veeva CRM, sample management, and speaker program governance · Strong cross-functional collaboration and team leadership skills **Preferred** : · Experience in pharmaceuticals, biotech, or healthcare · Experience leading design and deployment of Field and Leadership Capabilities training and development programs/services · Familiarity with compliance regulations such as the PhRMA Code and Sunshine Act · Background managing large-scale system rollouts and cross-functional field initiatives **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Director, Nephrology & Immunology Publications Lead is responsible for leading the planning, development, and execution of the global medical publication strategy and publication deliverables for the Nephrology and Immunology therapeutic area. This role ensures the timely, accurate, and compliant communication of scientific and clinical data through congress abstracts, posters, manuscripts, and other peer-reviewed outputs. Serving as the functional lead for publication operations within the Nephrology & Immunology Medical Communications team, the Director partners closely with cross-functional stakeholders, including Clinical Development, Global Integrated Evidence & Innovation (GIE&I), Medical Strategy, Core Content, and external vendors, ensuring excellence and consistency in scientific communication across the portfolio. The position reports to the Senior Director, Nephrology & Immunology Medical Communications Lead and plays a key leadership role in advancing Otsuka's mission to deliver impactful, evidence-based science that improves patient outcomes. **** **Key Responsibilities Include:** **Publications Strategy and Execution** + Lead execution of the publication plans for Nephrology and Immunology assets, ensuring strategic alignment with global medical objectives, data dissemination priorities, and the product lifecycle + Partner with Medical Communications and cross-functional teams to define publication timelines, data priorities, and congress/journal strategies in collaboration with study teams and medical leaders + Oversee the end-to-end development of publication deliverables, including abstracts, posters, and manuscripts to ensure scientific accuracy, quality, and adherence to Good Publication Practices (GPP), ICMJE, and company SOPs + Support the integration of publication insights into broader scientific communication platforms (SCPs), ensuring consistency across core content, field materials, and other medical channels **Vendor & Budget Management** + Manage publication vendors and medical writing partners to ensure timely delivery, cost-effectiveness + Oversee operational management of external publication agencies, providing clear direction, review, and feedback to ensure alignment with scientific and compliance standards + Manage assigned publication budgets, including forecasting, tracking, and reconciliation + Ensure efficient resource utilization and drive continuous process improvement across publication workflows **Cross-functional Leadership** + Collaborate closely with Clinical Development, Global Integrated Evidence & Innovation, Medical Strategy, and Core Content teams to ensure data readiness, accurate interpretation, and timely publication of key clinical results + Serve as a publications subject matter expert within the Nephrology & Immunology Medical Communications function, providing strategic and operational guidance to internal stakeholders and vendors + Partner with Field Medical and Medical Information to ensure consistency of published data messaging across medical channels and external communications + Contribute to integrated medical communication planning, ensuring that publications effectively support data dissemination goals and launch readiness activities + Consider technology and AI to support workflow improvement **Compliance & Quality Oversight** + Ensure all publication activities are conducted in accordance with internal SOPs, GPP, ICMJE, and regional/global regulatory requirements + Partner with Legal, Regulatory, and Compliance teams to uphold publication governance, authorship transparency, and ethical data sharing standards + Contribute to audit readiness and documentation best practices for publication records and approvals **Qualifications** **Education and Experience:** + Advanced scientific or medical degree (PharmD, PhD, MD, or equivalent) required + 10+ years of experience in Medical Affairs, Medical Communications, or Publications within the pharmaceutical or biotechnology industry + Minimum 3-5 years of experience leading publication planning and execution for global or regional programs, preferably in Nephrology, Immunology, or related therapeutic areas + Proven experience managing vendors and external medical writers, including budget oversight and performance evaluation + Strong understanding of Good Publication Practices (GPP), ICMJE guidelines, and industry standards for scientific and medical communication **Skills and Competencies:** + Strong leadership presence and ability to present to executive leadership team + Demonstrated ability to lead publication strategy execution across global and regional teams + Exceptional project management and organizational skills, with the ability to manage multiple concurrent publication deliverables + Excellent written and verbal communication skills, with meticulous attention to scientific accuracy and compliance + Strong cross-functional collaboration skills, with the ability to influence and align internal and external partners + Proven leadership in vendor management, process optimization, and publication operations + Financial acumen and experience managing publication budgets + Strategic thinker with operational excellence mindset and the ability to translate complex data into clear, evidence-based scientific narratives **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $205,368.00 - Maximum $307,050.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: Member of cross-functional teams, the primary purpose of the Associate Director is to act independently as Lead Safety Statistician (LSS) / Medical Affairs Statistician (MA) / Exploratory Statistician / Regional Statistician Lead (RSTATL) or Lead Product Statistician (LPS) for complex/novel work in an established area (safety/clinical/ observational studies, MA tactic, Biomarker & PK/PD Analyses or local project), This position may also act as Global Statistical Lead (GSTATL) for an early or back up asset or as a Methodology expert validating the execution of complex techniques. The position is expected to complete these tasks with minimal supervision from the GSTATL, LPS or the Primary Focus Statistics Lead (PFSL). Under the supervision of an experienced statistician, the position can act as global safety statistical lead for a late phase or novel asset or represent Astellas on statistical matters related to safety data, clinical data, Biomarkers, PK/PD, PROs, or methodology at meetings with regulatory authorities, key opinion leaders and HTAs. The position may also research innovative solutions and train other statisticians. Essential Job Responsibilities: Provides best in class safety data science and statistical support to the asset level for Astellas drug development programs. For assigned projects, provides all required safety statistical support and deliverables by supervising another statistician, or as a member of study team. Ensures quality and consistency of key safety data science deliverables. Accountable for the Asset Level Safety Assessment Plan (ALSAP). For early or non complex asset, independently provides strategic safety statistical input to the asset teams (for example, CDP, CMP, go/no go approach, OCs ) including design of studies and analyses requiring advanced statistical methodologies. Executes biomarker and PK/PD strategies, leads large/complex studies or supports marketed products for a safety purpose. Contributes to regulatory and payer dossiers and publications - provides statistical interpretation of the results. Presents summary data and analyses to key stakeholders in a compelling and clear manner Ensures availability of safety-related data, biomarker, external data, CRF integrated database(s) where needed, and planning and conduct of integrated analyses to support development decisions, submissions or marketing needs. May participate in due diligence activities, reviews safety data and advises company Is responsible to implement, explain and validate complex safety statistical methodology Personal Development / Collaboration Recognizes and addresses issues which may impact the statistical integrity of the development program or for which novel statistical methodology may add value Contributes to cross-functional or indication level improvement initiatives (i.e write SOP - select, validate and implement statistical software - standard output generation - creation of, maintenance and adherence to indication specific standards - selection and qualification/audits of vendors) Contributes to the recruitment, training, professional development and retention of statistical personnel. is a member of external industry or professional organizations, developing relations with leading academic institutions, advising internally on innovative Statistical methods or checking their correct implementation.

Band Level 5 Novartis has an opportunity for an Associate Director, Compliance Inquiries & Audits, who will perform internal investigations and root cause analyses (RCA) of content generated by US Integrated Marketing, as part of the Compliance & Risk Operations team. This role is crucial for resolving deviations related to marketing content, communicating with stakeholders, and discreetly responding to audits and legal queries to ensure marketing compliance, confidentiality, integrity, and operational excellence. The ideal location for this role is East Hanover, NJ but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to East Hanover, NJ for periodic live meetings will be at the employee's expense. This position will require 5-10% travel to various Novartis sites and external locations. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. Job Description Key Responsibilities: Intake and triage of identified content risks, gaining insights into circumstances, mitigators, and break downs for appropriate resiliency strategies Assessing and validating potential policy or process breakdowns through comprehensive fact gathering, including conducting informal interviews and thorough document reviews. Determining the root cause of confirmed breakdowns and mapping corrective actions to address these root causes effectively. Identifying proactive measures to prevent policy or process breakdowns from reoccurring. Ensuring the implementation and follow-through of corrective and preventative actions through necessary follow-up, in partnership with AD, Remediation. Maintaining detailed documentation relevant to potential compliance breakdowns and reporting findings comprehensively, operating with discretion and confidentiality. Identifying appropriate metrics to attach to remediations and measuring the potential effectiveness of these remediations. Assessing data over time to identify trends and opportunities for large-scale remediations and organizational priorities Project management and process ownership, being agile to drive optimization aligned to organizational priorities Essential Requirements: Bachelor's degree in a relevant field (e.g., Business Administration, Risk Management, Compliance, Enforcement). Advanced degree preferred. Minimum of 7 years of experience in a similar role within the pharmaceutical or highly regulated industry, with a strong background in compliance, risk management, and investigations Advanced understanding of how pharmaceutical marketing organization operates and the relevant controls they use to manage risk, including content review and production processes Strong analytical and deductive reasoning skills with strong written communication skills Approachable communication style that respects others and balances firmness with empathy Awareness of the various types of biases and how to ensure they are not introduced into work product Skilled in influencing without direct authority and capable of effectively communicating with individuals at various levels of the company Purpose-driven, high-integrity, clear, and compassionate business partner, positively impacting associate and organizational success Novartis Compensation Summary: The salary for this position is expected to range between $132,300 and $245,700 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to ************************ call **************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message. *************************************************************************************** Salary Range $132,300.00 - $245,700.00 Skills Desired Agility, Cross-Functional Collaboration, Customer Engagement, Customer Experience, Customer Insights, Data Analytics, Data Strategy, Digital Marketing, Marketing Strategy, Media Campaigns, Product Marketing, Stakeholder Engagement, Stakeholder Management, Waterfall Model

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: The Global Precision Medicine Lead role is responsible for the development and execution of biomarker and diagnostic strategies across drug development programs to develop tailored therapies that drive improved patient outcomes. The primary responsibility of a Global Precision Medicine Lead is to bring companion diagnostics through development to approval in collaboration with external diagnostic partners for Oncology and/or Gene Therapy. The role requires strong knowledge and experience in applied biomarker research and companion diagnostics development together with strong personal drive to deliver innovative solutions. Essential Job Responsibilities: Participates in the development and execution of precision medicine and diagnostic strategies for early and late-stage clinical development programs in oncology and other therapeutic areas. Contributes to the design of clinical studies that incorporate patient stratification, enrichment and biomarker testing including contribution to the relevant sections of study and regulatory documentation. Enhances drug success in early development through the implementation of precision medicine strategies to define the relationship between biomarkers and drug efficacy and safety. Facilitates biomarker testing of patient samples and interprets biomarker data from clinical studies to inform precision medicine and diagnostic strategies and generate data to support health authority submissions. Leads the evaluation and selection of diagnostic technologies and external diagnostic partners to support drug development programs. Leads the integration of companion diagnostic studies with drug clinical studies from development to approval through close collaboration with cross-functional teams and external diagnostic partners and vendors. Ensures compliance with regulatory requirements for diagnostic tests and precision medicine approaches implemented in clinical studies. Represents development as a subject matter expert on cross-functional diagnostic core teams for late-stage assets to drive successful diagnostic launches. Supports publication of data from precision medicine research studies.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: The Global Statistical Lead (GSTATL) for Solid Tumor Oncology is a compound level leader within the Quantitative Science & Evidence Generation (QSEG) organization, accountable for driving the statistical and analytical strategy for a compound or indication across its full development lifecycle. This position leads a cross-functional, integrated quantitative team supporting evidence generation and decision-making, with responsibility spanning clinical trial statistics, exploratory statistics, medical affairs statistics, real-world evidence (RWE), safety/pharmacovigilance (PV) statistics, statistical programming, biomarker statistics, and advanced analytics. The role ensures consistency and scientific excellence across studies, indications, and evidence types-while enabling innovation in statistical methodology, clinical development optimization, and external engagement. The GSTATL plays a key role in regulatory and payer strategy, as well as internal governance and portfolio planning for solid tumor assets. Responsibilities and Accountabilities: Strategic Statistical Leadership Serve as the compound-level statistical lead for solid tumor oncology, responsible for end-to-end quantitative strategy supporting clinical development, evidence generation, and regulatory/payer interactions. Lead development of integrated statistical strategies across all relevant study types and functions (e.g., e.g., phase 1b/2 signal-seeking, pivotal, exploratory, RWE, post-marketing). Align statistical and analytical approaches with the target product profile (TPP), development strategy, and external evidence needs. Cross-Functional Quantitative Team Leadership Lead and coordinate statistical and analytics contributions from a broad QSEG team, including: Clinical trial biostatisticians Exploratory oncology statisticians (e.g., tumor burden modeling, subgroup/signal detection) Medical Affairs statisticians Statistical programmers Biomarker/statistical genetics experts in oncology RWE analysts/statistical epidemiologists Safety/PV statisticians Advanced analytics and modeling specialists Ensure scientific alignment, quality, and integration across all statistical contributions at the compound level. Regulatory and HTA Engagement Represent Astellas on all statistical matters in global regulatory interactions (e.g., FDA, EMA, PMDA). Guide preparation of statistical content for regulatory submissions, briefing packages, and health technology assessment (HTA) dossiers. Lead the development of statistical components of payer evidence strategies, including indirect comparisons and external control methodologies. Innovation and Methodological Excellence Champion the use of oncology-appropriate innovations, including Bayesian designs, adaptive trial designs, external controls, tumor-agnostic approaches, and AI/ML tools to enhance study design and signal detection. Promote exploratory data analysis, modeling, and simulation to support rapid development decisions in Solid Tumor trials. Integrate clinical, biomarker, safety, and real-world evidence to drive cohesive, data-driven development and access strategies. Mentorship and Capability Development Mentor statisticians and analytics professionals across QSEG, supporting both scientific development and career growth. Share knowledge and best practices across study teams and therapeutic areas. Contribute to internal training, methodology development, and talent pipeline initiatives. Governance and Cross-Functional Influence Participate in global asset governance and development team meetings, influencing decisions with rigorous statistical insight. Collaborate with Clinical Development, Medical Affairs, Regulatory, Market Access, and Commercial to ensure alignment on evidence planning. Lead or contribute to internal initiatives, including standardization efforts, methodology forums, and innovation networks.

Otsuka America Pharmaceutical Inc. is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In its evolved customer engagement model, a Hospital Specialist engages healthcare providers (HCPs) using in-person, virtual, and digital tools, offering expertise on products and their approved conditions. This model enhances patient, caregiver, and HCP experiences by focusing on local care delivery, aiming to improve patient care and provide a superior experience. The "ecosystem approach" unifies account management, medical, patient access, and market access teams to engage with local healthcare systems, identifying opportunities to enhance the patient experience. This matrix model ensures coordinated and seamless care, supported by digital tools to bridge care gaps. These ecosystems are led by Area Business Leads and are organized into regional areas. Area Business Leads have significant autonomy to assess unique market priorities and tailor decisions to meet local customer needs. In the future, Otsuka aims to enhance customer engagement quality, accountability, and cohesion between patients and healthcare providers, with a focus on customer-centricity. The Hospital Specialist will report directly to the respective Area Business Lead, coordinating with cross-functional colleagues in Medical, Market Access, and Patient Support under appropriate guidelines. This individual will serve as the primary point of contact for HCP customers and should possess a broad range of expertise, capable of addressing complex on-label information based on approved content. **Purpose** This position is designed to enhance customer engagement, thought leadership, and business planning within the organization. The role involves proactive outreach to healthcare professionals (HCPs), facilitating discussions, and elevating insights to inform strategic decisions. Below is a detailed overview of the key responsibilities and objectives associated with this position: **Key** **Responsibilities** + Conduct proactive outreach to HCPs on topics such as product access, on-label information, and established patient care guidance. + Engage customers through various virtual or digital tools and direct them to other colleagues (e.g., MSLs) as needed. + Facilitate speaker programs and organize local provider groups for discussions on experiences and outcomes with local/regional leaders. + Elevate opportunities and feedback to the Area Business Lead, including local market insights to inform local strategy and business goals. **Experience & Qualifications** + A minimum of 2 years of pharmaceutical or medical device sales experience. + Must reside within a commutable distance of 50 miles from the primary city in the sales territory. + Previous cross-functional industry experience in commercial life sciences or related industry. + 4 or more years of experience working in a sales role with HCPs, ideally representing multiple products. + Ability to work in an ambiguous environment undergoing transformation. + Proven track record in coaching, training, and mentoring peers or others. + Demonstrates a commitment to ethical business practices, an understanding of regulatory standards, and the ability to execute business activities in compliance with Company policies and guidance. + Ability to assimilate and communicate complex clinical and product information **Key Sales Capabilities** + **Territory Analysis / Business Planning** + Uses competitive data and business reports to track progress and uncover opportunities, including sales data and promotional budget + Displays knowledge of territory and business conditions that impact sales results to establish near term priorities for his/her territory business plan + Responds compliantly to competitive threats and opportunities + Educates office staff on payer guidelines and reimbursement procedures to increase pull through + Effectively utilizes promotional materials + **Selling Skills, Engagement & Account Pull Through** + Maintains ongoing awareness of internal support team resources available throughout the ecosystem and utilizes appropriately + Applies market and industry knowledge to overcome objections and influence prescribing habits during the total office call + Identifies territory professional groups to network and ensure access/exposure to potential key opinion leaders + Builds strong relationships with all key office/practice personnel and focuses on patient health in conversations with all staff members. Takes personal responsibility for follow-through and providing value to the accounts by providing accurate information in response to their needs + Delivers effective and balanced office calls and sales presentations utilizing the appropriate approved marketing materials and technical references (e.g. studies, package inserts, etc.) with clarity and confidence to help HCPs enhance patient outcomes; demonstrates competent product knowledge of own product and competition **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $112,800.00 - Maximum $162,150.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Compensation Data This position offers a base salary typically between $220,000.00 and $350,000.00 USD. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. Description As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Group Lead, Medical Writing ExpMED, is accountable for the organizational set up, development, implementation, and oversight of a high-performing, innovative Medical Writing group for the early phase, and the development and oversight of an ExpMED Medical Writing excellence strategy (i.e., acceleration of clinical development timelines, use of AI, and creation of patient value while maintaining high quality) via strategic planning and execution of early clinical documents across all Therapeutic Areas. The Group Lead, Medical Writing ExpMED, in alignment with Head of ExpMed Clinical Operations (ExpMED CO) and ExpMED Leadership team, contributes to overall ExpMED strategy. The Group Lead provides leadership and guidance to a diverse team, creates an environment that inspires, motivates, and empowers colleagues, fosters a culture of continuous learning, knowledge sharing, improvement, innovation, accountability, and collaboration to accelerate clinical trial delivery and maximize value for investigational sites, patients, and the organization. Duties & Responsibilities • Develop and implement a global early phase Medical Writing excellence strategy that simplifies processes, sharpens focus, and accelerates clinical development across all Therapeutic Areas. • As part of the ExpMED Clinical Operations department, you will build and continuously enhance a high-performing and innovative global Medical Writing team. • Accountable for the creation and continuous refinement of a world-class ExpMED Medical Writing (MW) department to effectively deliver in the early phase. • Accountable for talent attraction, development retention, and succession planning within ExpMED (MW), in close alignment with HR. Group Lead MW in close alignment with other members of the ExpMED CO Leadership team, is responsible for functional talent development within ExpMED CO. • Accountable for the creation of an environment that inspires, motivates, and empowers colleagues within ExpMED MW to accelerate clinical development timelines and to create value for patients and the healthcare system. • Accountable that staff is well trained and qualified; supports staff in technical and personal skills development to support career progression. • Leads the communication of scientific programs and holistic evidence to key stakeholders, including investigators, regulators, payers, patients, and caregivers. • Oversees capacity planning, financial management, and the strategic deployment of internal and external (CRO) resources to support clinical program needs. • Provide oversight to constantly improve ExpMED MW processes and standards to prevent and/or remedy quality and/or compliance findings (in-house and/or CRO setting) to ensure early clinical execution excellence, in alignment with other Corporate functions. • Representation of Boehringer Ingelheim at external meetings and conferences to create value for Boehringer Ingelheim and external stakeholders. Requirements • Minimum of Bachelor's degree required; advanced science/clinical degree (PharmD, M.D., DNP, DO, Ph.D., Master's), strongly preferred. • 10+ years of professional experience in a scientific, clinical, and/or medical space. • Strong leadership skills with the ability to inspire and motivate to build a high-performing, innovative team. • Comprehensive understanding of drug development and reporting process required for study reports, submission documents, and data transparency deliverables across multiple providers. • Experience in (at least passion for) storytelling. • Knowledge of vendor processes, contracting, and best practices in outsourcing; ability to influence vendor improvements. • Demonstrated experience presenting to scientific and non-scientific audiences. • Experience managing multiple, complex projects, and a strong record of developing successful partnerships and meeting customer expectations in global settings. • Strategic mindset with the ability to drive innovation, digital transformation, and process integration across complex, global environments. • Expertise in globalizing functions to operate in a standardized fashion. • Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with colleagues and vendors. • Proactively identify gaps, emerging risks, and opportunities for improvement through ongoing analysis and benchmarking to maintain industry leading position • Encourages the adoption of new technologies, smart risk-taking, and a unified ExpMED CO identity that empowers teams and accelerates clinical development. • Demonstrated ability to build, lead, develop and maintain a high-performance, medical writing team. • Remote*: this position is considered remote based. Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: This position is accountable for the planning, set-up and execution of assigned drug trials which may include: pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional). This position is accountable to the Clinical Operations Lead and will lead the cross-functional clinical extended team to ensure efficient and compliant clinical trial set-up, execution and delivery of assigned trials. This includes vendor selection, implementation and oversight of all trial-related processes and plans in support of protocol execution and mentoring and coaching of clinical staff during execution of development trials. Individuals may serve in regional capacity to represent Clinical Operations in Key Opinion Leader (KOL) interactions, communications; Interactions and submissions to Health Authorities within their region/country of responsibility. In these cases, they are accountable to the asset team for relevant feedback/input. This position may be responsible for managing one or more trials and is accountable for the effective management and oversight of clinical trial budgets, timelines and resources to meet the defined deliverables. Represents pre/post-POC Clinical Operations at clinical extended teams or equivalent, portfolio and operational review meetings, primary focus area governance, and cross-functional process improvement projects, as applicable. Essential Job Responsibilities: Manage and lead the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. Manage and lead cross-functional trial teams, including vendor set-up, performance oversight and closeout activities Responsible for oversight and guidance to clinical study team members in completing deliverables according to agreed timelines and quality standards, including awareness and escalation of high impact quality-related topics for assigned studies. Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members Lead or oversee development of core study documents, study plans and systems set-up to ensure operational excellence in execution of the clinical trial protocol and quality across investigative sites, vendors and data. Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues, internally and externally. Provide input on clinical operational/development matters for interactions with regulatory authorities and key opinion leaders, either globally or regionally. Lead preparation of vendor requirements and assess vendor capabilities to support trial scope and selection of qualified vendors; effectively manage interactions with vendor project management team Lead feasibility assessment and selection of countries and sites for trial conduct. Facilitates site engagement and communications with investigators and/or staff to support study milestones and deliverables Participates in and/or facilitates cross-functional collaboration and strategic problem solving to ensure risk mitigation, appropriate progress and timely completion of trials and deliverables according to established objectives, milestones and goals. Provide accurate and up-to-date trial information in relevant tracking systems and provide regular updates of trial progression to the Clinical Operations Lead and other defined stakeholders Participates in inspection readiness activities including coordination of clinical study team deliverables. Individuals may serve in regional capacity to represent Clinical Operations in submissions and interactions with Health Authorities or other (external) activities as applicable. Individuals may provide regional clinical strategies directly or indirectly to asset team, in collaboration with clinical operations lead, to optimize global development strategy Facilitate and manage regional KOL interactions, as applicable. Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; support development of data review plans, review of statistical analysis plans and participate in data reviews and manage data findings. Participate in process improvement and quality-related initiatives associated with trial execution and deliverables; participate in establishment of best-in-class processes and standards for trial conduct. Provide oversight and direction to trial team members for trial deliverables, including ensuring the evaluation and implementation of patient-focused strategies for assigned trials, globally and regionally, as appropriate. Performs other duties as assigned or special projects as needed.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: The Pharma Physician Development Program is a premier two-year rotational program designed to equip high-potential clinicians with critical insights into the pharmaceutical industry while fostering business acumen, leadership skills, and scientific expertise. Through three diverse rotations-Clinical Development (12 months), Medical Affairs (6 months), and Pharmacovigilance (6 months), Participants will gain hands-on exposure to key functions that drive product innovation and patient impact. Throughout the program, participants will receive in-depth training on the Product Development Lifecycle, develop essential leadership abilities, and gain valuable knowledge and experience working with cross functional teams to support Product Life Cycle Management. This experience is supported by mentorship and networking opportunities that create lasting foundations for career success in the pharmaceutical industry. Responsibilities and Accountabilities: Participants will contribute to Astellas programs across three key functional areas and gain a 360 degree view of drug development. This will require participation in 3 specialized rotations: Clinical Development (12 months) Collaborate as part of the leadership of the clinical team to support the definition of the clinical hypothesis, the clinical development plan (CDP) including Life Cycle Management (LCM) and execution of clinical programs. Engage in clinical study design, preparation of essential clinical documents (e.g., Investigator Brochure, Protocols, Clinical Study Reports), and global health authority interactions. Participate in medical monitoring, clinical safety and efficacy data review, and evidence generation strategy creation based on stage of product development. Support clinical and program risk assessment and mitigation planning Work cross-functionally on study-level activities (including operational readiness and execution required to deliver trials within timelines and budgets), stakeholder collaborations within matrix-based Asset Maximization teams to support efficient and timely decision making at governance discussions. Medical Affairs (6 months) Support the development and execution of regional growth strategies, planning the MA strategy aligned with LCM nd alignment of Global Brand Strategies. Identify medical data gaps based on SWOT analyses lead Medical Affairs scientific initiatives, participate in Medical Legal Review (MLR) and support internal training programs for field teams (e.g., MSLs and Sales Reps ). Drive the design and execution of clinical and Real-World Evidence (RWE) studies, as well as HEOR initiatives for data generation advisory boards and external engagement for strategic insight collection, publication and congress planning, medical communications and medical education programs. Embed agile ways of working while fostering collaboration across commercial and Medical teams. Pharmacovigilance (6 months) Develop hands-on experience in safety monitoring and risk management throughout the drug lifecycle. Develop an understanding of global pharmacovigilance regulations by engaging in activities such as signal management, aggregate reporting, and causality assessment in individual case safety reporting. Develop an understanding of optimizing the benefit-risk profile of a product by participating in Safety Management Teams, Benefit Risk Teams and engaging in risk management planning and product label discussions. Collaborate with teams on inspection readiness, QMS reviews and CAPAs. Learn the fundamentals of relevant databases (e.g., LSLMV), dictionaries (e.g. MedDRA) and their use in both pre- and post-marketing safety surveillance. Throughout the Program Participants will benefit from additional developmental opportunities, including: Business Acumen Training: Gain specialized knowledge of Astellas' business processes, operational frameworks, and market dynamics. Product Development Lifecycle Training: Develop a comprehensive understanding of the pharmaceutical innovation process, from concept to commercialization. Leadership Skill Development: Build core leadership capabilities through mentorship, direct industry exposure, and structured training programs. Cross-Functional Insights: Connect with and learn about relevant functions, including commercial, regulatory, and clinical teams, while engaging in collaborative decision-making processes. Why Join the Program? This program offers: Mentorship: Receive guidance from experienced leaders across scientific, clinical, and business disciplines. Leadership Development: Participate in curated experiences designed to build strategic leadership skills for success in the pharmaceutical industry. Pharmaceutical Insight: Gain immersive exposure to Clinical Development, Medical Affairs, and Pharmacovigilance. Cross-Functional Networking: Engage with professionals across global and diverse teams, fostering collaboration and networking opportunities. Embark on a transformative journey into the pharmaceutical industry that will position you as a future leader in clinical, medical, and scientific innovation.

The Cardiovascular-Renal Sales Consultant is responsible for partnering in developing and implementing a plan for brand sales growth of BIPI and co-promoted cardio-renal-metabolic (CRM) products that aligns with direction from BIPI commercial leadership and with BIPI guidelines, policies, and directives. The Cardiovascular-Renal Sales Consultant will conduct their business with key targeted healthcare providers (Cardiology specialists/Nephrology specialists/Advanced Practice Clinicians and Allied Healthcare Professionals). The consultant will have additional responsibilities for sales activities in teaching and community hospitals, federal and military hospitals, heart failure clinics, managed health care facilities, and integrated delivery networks, etc. utilizing in-person and/or digital/virtual platforms. The CR consultant is also responsible for generating advocacy for BI products with Key Decision Makers in the hospital accounts they are responsible for. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities Executes brand strategies to ensure that company sales and marketing messages are delivered appropriately to customers. Leverages knowledge of cardiology, nephrology, diabetes, and the marketplace to anticipate and effectively manage business opportunities and challenges. Demonstrates knowledge of the disease state, key drivers, influencers, and prescribing patterns in territory. Establishes and maintains effective communication/cooperation/coordination with co-promotion partners and BIPI employees. Works effectively with all customer-facing roles (i.e.. account teams, medical teams, etc.) in each geography to meet customer needs and deliver net sales objectives. Demonstrates knowledge of BIPI cardio-renal-metabolic (CRM) products and related marketplace, effective translation of product knowledge into the sales presentation and is customer focused with a priority directed towards providing solutions-based customer interactions. Delivers high level of clinical and technical value to his/her customers, assisting the health care customer in meeting their unique patient care needs, all within BI regulatory guidelines. As a trusted CR Consultant, encourages and receives requests from customers for technical information outside of standard visits. Through all these endeavors, develops trust and subsequent value with customers. Drives appropriate utilization of approved Cardiovascular-Renal products. Uses appropriate BIPI Sales Training techniques to facilitate the customer decision making process. CR Consultant works closely with other commercial associates to generate pull-through within local payers, hospitals, community Health Care Providers. Fosters cardio-renal customer network development and communication. Coordinates the engagement of healthcare providers through a range of personal and non-personal channels, according to customer preferences. The CR consultant must demonstrate the ability to engage with customers through a variety of digital media and platforms (live, remote video conference, marketing email etc.) and integrate digital assets and strategies into broader territory-level business plans. Delivers on "continuation of care" model, including discharge protocol, treatment algorithms, disease management, etc. Supports the efforts in various care settings to include appropriate pull through of protocols, pathways, order sets, formularies, treatment algorithms, transition of care, and population health management initiatives to assist with the delivery of optimal care. Requirements This is a dual level posting. Candidates will be hired at the level commensurate with their experience and business need. Cardiovascular-Renal Sales Consultant Requirements: Bachelor's degree preferred. At least three (3) years of experience in pharmaceutical sales of which one-plus (1+) years of experience in the promotion of cardiovascular and/or diabetes and/or nephrology pharmaceuticals. Hospital and/or Account Management experience preferred. History of successful performance. Meets expectations for the key competencies required for this role. Proficiency in Excel, Word, Outlook, and database applications. Ability to travel (may include overnight travel). Should reside in territory geography or be willing to relocate. Valid driver's license and an acceptable driving record. Authorization and ability to drive a company leased vehicle or authorized rental vehicle. Executive Cardiovascular-Renal Sales Consultant I Requirements: Bachelor's degree preferred. At least five (5) years of experience in pharmaceutical sales of which two-plus (2+) years of experience in the promotion of cardiovascular and/or diabetes and/or nephrology pharmaceuticals. At least one-plus (1+) Hospital and/or Account Management experience required. History of successful performance. Meets expectations for the key competencies required for this role. Proficiency in Excel, Word, Outlook, and database applications. Ability to travel (may include overnight travel). Should reside in territory geography or be willing to relocate. Valid driver's license and an acceptable driving record. Authorization and ability to drive a company leased vehicle or authorized rental vehicle. Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States regulatory frameworks and global CMC strategy. This role will lead the development and execution of innovative regulatory strategies for small molecule products (primarily) and biologics or other new modalities (secondary) across all phases of development and commercialization. The ideal candidate will be a recognized thought leader who can influence regulatory policy, drive strategic initiatives, and represent the company in key external forums. This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. Responsible for multiple regulatory activities in collaboration with local and global stakeholders (e.g., Product Development & Manufacturing, Regulatory Affairs, Quality Assurance, Business Partners). Responsible for developing regional/global CMC regulatory strategy (e.g., CMC strategy/planning for new products), driving CMC submission related activities and successfully executing regional/global regulatory strategies in collaboration with local and global stakeholders. Responsible for supporting business critical interactions inside and outside of Astellas Regulatory Affairs on complex CMC issues and questions in collaboration with local and global stakeholders. Leads and/or coaches a team or individual team member of regulatory CMC professionals. The ideal candidate brings deep expertise in designing and executing innovative, accelerated CMC regulatory strategies across oncology and rare disease portfolios. This includes demonstrated experience navigating global expedited pathways such as FDA Breakthrough Therapy, PRIME, Project Orbis, and other rapid-review designations. The candidate will lead the development and implementation of forward-leaning CMC approaches that enable faster patient access while ensuring robust quality, compliance, and lifecycle readiness. Success in this role requires strong strategic acumen, cross-functional leadership, and a proven ability to partner with health authorities to shape regulatory solutions that support program acceleration and long-term product sustainability. Responsibilities and Accountabilities: Strategic Leadership: Define and implement global CMC regulatory strategies with a strong focus on North American requirements. Provide expert guidance on US FDA regulations, while also ensuring compliance and proactive risk management across major markets including Japan, China, and EU. Policy & Advocacy: Represent the company in industry associations, ICH working groups, and industry forums to influence regulatory policy and harmonization efforts. Monitor evolving regulatory landscapes in the US and other global countries, translating changes into actionable strategies for internal teams. Cross-Functional Collaboration: Partner with Product Development & Manufacturing, Quality Assurance and Regulatory Affairs teams to ensure alignment on CMC strategies. Serve as a scientific and regulatory resource for complex technical issues, enabling science and risk-based solutions. External Engagement: Build and maintain strong relationships with FDA, PhRMA, ICH, other regulatory authorities and industry collaborations. Lead advocacy initiatives for innovative technologies and precedent-setting projects. Operational Excellence: Oversee preparation and review of CMC sections for regulatory submissions (IND, NDA, BLA, post-approval changes). Ensure consistency and quality in dossier preparation across regions. Expected Key Accountabilities from Global Regulatory Aspects Acts as CMC regulatory expert and is accountable for recommending global CMC regulatory strategy. Works closely with other individuals/groups within Astellas global Regulatory Affairs and with regional and global stakeholders to ensure consistency and to identify options for risk discussions. Member of global teams/task forces which require expert interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization. Sets direction for key operations and new initiatives in collaboration with regional and global stakeholders. Provides CMC regulatory expertise for New Product Planning and Licensing including during due diligence activities. Provides oversight on the preparation and review of complex global registration packages to ensure effective data presentation and quality scientific data against applicable regulatory requirements. In collaboration with regional and global stakeholders, determines the best way to present information in assigned regulatory submissions to maximize reviewability by global health authorities. Defines and implements regulatory strategies and priorities for; global registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control issues in collaboration with local and global stakeholders. Reviews global regulatory submissions for consistency and quality across regions including detailed input on eCTD Module 3 documents for clinical trial and marketing authorization registration filings and DMFs. Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for chemistry, manufacturing and controls aspects. Provides regulatory guidance for compendial issues (Ph.Eur., USP and JP etc.) and monograph preparation. Provides support to the CMC RA Modality Head to develop an environment to enable CMC RA professionals to optimally operate in the matrix environment of RA, R&D, Product Development & Manufacturing within Astellas. Leads and/or coach a small team or individual team member of (regulatory) CMC professionals, provides training. Interacts with executive level on routine and serious matters; internally and externally to influence policy and strategy; with development partners; with global health authorities at review, management and senior staff, including negotiations on controversial areas. Established rapport with global health authorities that enables constructive exploratory discussions. Facilitator role in health authority meetings. Works on complex and diverse problems with decision making that has functional or corporate impact. Actions may have serious implications for operations, revenue, and/or credibility.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: The Clinical Modeling, Analytics & Operational Excellence team is a high-impact innovation team that applies advanced analytics, real-world data, modeling & simulation, and AI/ML to solve critical challenges in clinical development. This team designs and implements predictive models for patient recruitment and retention, optimizes trial feasibility and site selection, assesses novel clinical endpoints, simulates study outcomes to guide protocol design, and develops innovative operational strategies to reduce execution risk and accelerate timelines. The Clinical Modeling & Analytics Innovation Scientist will shape the future of data-driven clinical development by pioneering innovative solutions at the intersection of AI/ML, advanced analytics, modeling and simulation. This position collaborates closely with colleagues across clinical, biostatistics, real-world data, clinical operations, and digital/IT to improve feasibility assessments, enhance enrollment forecast, deepen data exploration and optimize trial decision-makings. In addition, the Clinical Modeling & Analytics Innovation Scientist will be at the forefront of innovation, developing novel methodologies and driving adoption of emerging technologies (e.g., generative foundational models, digital twins, and advanced imaging analytics) to transform clinical trial strategy and execution. Essential Job Responsibilities: The Clinical Modeling & Analytics Innovation Scientist Contributes to cross-functional initiatives by collaborating with cross-functional teams and applying clinical modeling & simulation, advanced analytics, and AI/ML to trial design, feasibility, and execution optimization. Implements and delivers simulation and predictive models to inform and optimize clinical trial planning, protocol development, patient recruitment and retention across therapeutic areas. Contributes to the development and maintenance of clinical modeling & data strategy and roadmap dedicated to specific business areas. Collaborates with medical, biostatistics, real-world data, and operational teams to embed clinical modeling & analytics insights into protocol development, portfolio planning and decision-making Stays current with emerging technologies, proposes and develops innovative modeling and analytics methodologies, and leads or contributes to internal training and external publications and presentations

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. **Purpose and Scope:** + Coordination and execution of work within the Site Contract, Budget support function in support of both early and late-stage Clinical Operations and may include support for other functions (Medical Affairs). + This position is responsible for the establishment and maintenance of global best practices as it relates to applying the relevant regulatory, legal requirement and global data privacy requirements in the support of clinical trial execution that adhere to Astellas and GCP/ICH requirements. + This position will collaborate with Astellas Legal/Data Privacy Organizations, Ethics & Compliance and other external stakeholders as required. + This position will contribute to project level timelines and will report on performance timelines both during feasibility and throughout the lifecycle of contract/budget negotiation. + This position is accountable for the efficient delivery of core and country templates for clinical site operational documents that maintain regulatory and corporate compliance, operational and legal standards, while ensuring contracts are delivered to meet study/project timelines. + This position may be responsible for managing direct reports and may additionally include oversight of contractors. **Responsibilities and Accountabilities:** + Responsible for development of final processes, standards and tools for utilization within either both Site Contracts and Site Budget or a specific area of focus (e.g. Site Contract or Site Budget, including global implementation with the project team. + Draft of guidance documentation(s) and training. + Manages the changes of the documents, templates or training under their purview. + Serves as primary liaison to collaborate between business and designated legal partners (as needed) to support development of global templates and processes to help ensure timely, proactive, strategic, best-in-class legal advice and support, taking into account objectives of the organization, and the unique and varying global, regional and local legal and regulatory requirements in a risk-balanced manner in order to effectively minimize and mitigate risk to the business. + Participates in strategic improvement/innovation projects as requested. + Responsible for the preparation and management of functional budgets and resources and oversight of related components of trial budgets and timelines and resources for all clinical studies related to these positions. + Support for Industry Best Practice investigation and implementation. + Support for development of related metrics for functional area, including measurement, and monitoring including recommendations to enhance performance of study start up. + Management of any CRO resources necessary for study delivery. **Required** + Bachelor's Degree or equivalent relevant experience + At least 10 years prior experience handling and executing on functional specific material (e.g. contracts, budgets, payments or informed consent form) matters with at least 5 years directly involved with a company within the pharmaceutical/ biotechnology industry. Global experience preferred. + Good understanding of the regulatory, legal and data privacy issues affecting the pharmaceutical industry, including GDPR as it relates to the core and country templates. + Strong ability to grasp regulatory and legal issues quickly, exhibit strong analytical problem solving and decision-making skills, exercise sound judgment and provide practical and constructive legal advice. + Strong negotiation and communication skills (both oral and written). Ability to communicate legal issues in a clear and understandable manner. + Must have a strong knowledge of clinical development processes and ICH/GCP + Experience in a Manager or equivalent role with responsibility and demonstrated success in execution of strategies for relevant non-project support functions. + Must have excellent interpersonal, written, verbal, and computer skills. + Minimal (10-20%) travel required + Fluent in English + Direct people management experience is preferred **Salary Range** $141,400 - $222,200 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program \#LI-SS Category Site Activation / Late-Stage Management Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans