Horizon Pharma USA, Inc. jobs

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Have you got what it takes to succeed The following information should be read carefully by all candidates. Job Description OBJECTIVES/PURPOSE: Reporting to the Head, Global Regulatory Operations (GRO), the Head of Global Regulatory Information, Data and Systems (GRIDS) is responsible for developing and implementing a comprehensive GRIDS strategy. This pivotal role ensures Takedas regulatory data integrity while driving the adoption and efficiency of Regulatory systems globally. This role involves guiding and mentoring a team of experts, driving regulatory data quality confidence, ensuring global system reach and adoption, and enhancing efficiency through data connectivity across Global Regulatory Affairs (GRA), Research & Development (R&D), and the enterprise. Additionally, the role leads accurate and timely reporting for both common and ad hoc regulatory affairs questions. ACCOUNTABILITIES: Global GRIDS Strategy Development and Realization: In partnership and collaboration with GRA and GRO leadership, Takeda IT functions, R&D cross-functional, and enterprise stakeholders, develop and align global GRIDS strategy and roadmap. Execute and track GRIDS strategy through agreed to set of milestones, key deliverables, activities, and monitor progress through metrics. Proactively identify and manage risks and issues. Ensure ongoing stakeholder engagement and awareness throughout. Align and structure internal GRIDS team to enable strategy realization and deliverables. Define team roles and responsibilities and ensure alignment across GRO and other functions to ensure clarity and synergy. Develop and implement team norms and ways of working, driving delivery focus and prioritization. Actively mentor and guide direct reports in the execution of deliverables. Ensure external vendor support for GRIDS activities is clearly defined and, in partnership with Business Operations team, is delivering to specified service level agreements. Actively provide vendor oversight and engage with vendor(s) to ensure process and ways-of-working clarity and adoption. Data Governance and Sustainability: Establish robust regulatory data governance and stewardship practices and ensure data quality assurance for authoritative regulatory data sources. Proactively drive data remediation efforts as needed to ensure high data quality. Lead initiatives for regulatory information standards adoption and ensure organizational readiness to meet regulatory requirements, including eCTD4, SPOR/IDMP, and CTIS/EU CTR. Oversee master data management for regulatory data and partner/ drive connectivity with RD and enterprise systems. GRIDS Data Analytics: Drive GRIDS business intelligence and data visualization capabilities to support data-driven decision making for Therapeutic Areas Units (TAUs), regulatory leadership, and other stakeholders for pipeline realization and post-approval lifecycle management. Provide standard regulatory reports and dashboards and produce ad-hoc and custom regulatory reports as requested. GRIDS System Business Ownership: Partner with Takeda IT functions to drive the evolution, interoperability, data sharing, and integration of Takedas global GRIDS systems. Ensure business requirements are identified and adequately translated into system and supporting business process functionality. Support system release management, data migration and validation activities. Collaborate with GRA functions, regions, and local operating companies (LOCs) to drive system adoption and utilization. CORE COMPETENCIES: Strategy Development: Ability to create and implement long-term GRIDS strategies with a forward-thinking approach. Influential Communicator: Exceptional communication skills to articulate complex regulatory data concepts effectively. Collaborative Leader: Strong leadership qualities to guide cross-functional teams and drive organizational change. Innovative Thinker: Proactive in embracing innovation and leveraging technology to enhance RIM processes. Results-Oriented: Focused on achieving measurable outcomes and driving continuous improvement. Analytical Skills: Strong analytical skills to interpret regulatory data and deliver insightful reports and visualizations. QUALIFICATIONS: Minimum Bachelor's Degree, MS preferred; 15+ years of experience in the life sciences, particularly in Regulatory Affairs and Regulatory Information, Data and Systems. Experience in leading global Regulatory Information, Data and Systems capabilities and teams. Credibility and experience engaging at senior levels for the development and alignment of GRIDS strategy. Ability to hold strategic conversations with Regulatory, R&D and enterprise stakeholders regarding global Information Management processes and systems and the regulatory applications and their use within Regulatory execution. Demonstrated experience in designing and implementing RIM digital transformation with proven ability to innovate across business processes and technology solutions. Experience with regulatory processes and technology for submission document authoring, submission publishing/validation/viewing, registration and commitment tracking, and regulatory document archiving. Experience with regulatory data standards, such as xEVMPD and IDMP. Deep understanding of the entire R&D value chain, particularly data taxonomies and domain integration. Understanding of global drug development & regulatory processes. Experience with Veeva RIM platform for health authority registration management. Experience directly working with Registration Management, Submissions, Submissions Archive, and Publishing technologies, a plus. Proven track record of thought leadership through industry presentations, publications, or other mechanisms, a plus. This position is currently classified as hybrid by Takedas Hybrid and Remote Work policy Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $208,200.00 - $327,140.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Check all associated application documentation thoroughly before clicking on the apply button at the bottom of this description. Job DescriptionAbout the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Takeda is committed to creating better health for people and a brighter future for the world. Guided by our OneOncology vision, we are advancing a rapidly growing oncology portfolio with potentially first-in-class and best-in-class therapies, including ADCs, complex biologics and small molecules. Our goal is to accelerate access to transformative medicines and make a lasting impact on patients worldwide. Join Takeda as a Senior Manager, Global Regulatory Lead Oncology where you will be part of the global regulatory team to develop strategies to maximize regulatory success towards achievement of program objectives. In this role, you will provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. How you will contribute: Manage one or more projects with less complexity. May support the GRL on more complex programs. May lead working groups and represent Global Regulatory Team (GRT) at project team meetings. Provide strategic and tactical guidance to teams, including regulatory review of clinical trial documents and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance. May communicate with FDA as required. Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Contribute to US FDA submissions and approvals for project(s) within scope.The Manager may lead less complex multi-function submissions, such as original INDs or support GRLs for more complex submissions, including major global marketing applications. Assist in preparation for and may attend FDA and other agency meetings. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Attend study team meetings and provide regulatory guidance. May participate on departmental task-forces or initiatives. Partner with functions responsible for ensuring market access and regional GRA leads to understand market access topics and strategize opportunities to strengthen product development plan(s) and build into global integrated regulatory strategy. Minimum Requirements/Qualifications: Bachelors Degree required, scientific discipline strongly preferred, advanced degree in a scientific discipline preferred. A minimum of 4 years of pharmaceutical industry experience. This is inclusive of 4 year of regulatory experience or combination of 2 years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Basic working knowledge of drug development process and regulatory requirements. Understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects. Demonstrate acceptable skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrate acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $137,000.00 - $215,270.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are committed to lifelong learning. To that end, Takeda's summer internship program blends real world experience with an overview of the pharmaceutical industry. Knowledgeable mentors will provide guidance as you gain professional hands-on experience to start your career or further develop in your expertise. The US Health Economics and Outcomes Research (HEOR) Summer Intern will have the unique opportunity to support two Health Economics and Outcomes Research teams within Takeda's Value & Evidence Generation function: (1) New Product Planning (NPP) HEOR and (2) therapeutic area HEOR. The US NPP HEOR team is responsible for providing the US voice into product development from Phase 2 to about two years before US launch. The team works with other US NPP and global cross-functional colleagues to ensure clinical trials and evidence needs (e.g., epidemiology, burden of illness, cost, etc.) align with downstream patient, payer, provider' requirements. Continually, the TA HEOR team will be in partnership with the medical team, develop and execute the evidence generation plans to accelerate product access and improved patient care. The US HEOR summer intern will support the US HEOR teams by engaging in research projects/activities to support one or more of Takeda's pipelines/assets in neuroscience, rare disease, immunology, dermatology, and/or gastrointestinal disorders. Responsibility may include: Research and Analysis * Conduct target literature search to inform HEOR study rationale, development/refinement of research question(s), propose study ideas and methodology * Independently or collaborate with Takeda analytical teams and conduct analyses using in-house claims/EMR databases Health Economics * Assist in developing a value framework to assess holistic values of pipelines Communication and General Support * Assist in developing materials such as slide decks to communicate research findings * Help manage project timelines and deliverables Other Key Responsibilities: * The intern will understand why the research is being conducted and how the results will be applied to asset development. * The intern will participate in cross-functional meetings, collaborations between medical and commercial teams, meetings with US and global partners, and project work interactions with vendors. During the internship, opportunities will exist to better understand the role of medical affairs and health economics and outcomes research in drug development from a US perspective and to explore careers in medical affairs. * The final scope of the intern's responsibilities will be determined after starting the position and in alignment with both learning and business needs. Internship development opportunities * Gain real-world research experience and contribute to the launch of pipeline assets * Develop understanding of payer strategy and engagement in pre-launch setting * Gain exposure to US medical affairs organization and cross-functional, highly-matrixed environment Job Requirements: * Current Graduate/PhD student with at least one year of university studies prior to starting the internship * Preferred majors: Epidemiology, Health Economics, Health Science Research, and other research-related majors * Preference for candidates with a demonstrated understanding of the US healthcare system and the US payer landscape * Deadline-driven with a high level of organizational and planning skills\ * Strong analytical, problem-solving, and oral and written communication skills * Ability to work well in teams, effectively manage projects, and present ideas clearly and concisely * Excellent communication and leadership skills * This is a remote position Internship Eligibility * Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship * Must be currently enrolled in a degree program graduating December 2026 or later * The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st) * The intern must be able to commit to one of these time frames * Able to work full time 40 hours a week during internship dates * Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program Program Highlights: * Hands-on experience with real projects and responsibilities * Dedicated mentorship program pairing interns with experienced professionals * Networking opportunities with industry professionals and fellow interns * Internship events focused on professional and skills development * Exposure to multiple business areas or departments within a Pharmaceutical Organization Applications will be accepted between October 31st- November 16th Takeda Compensation and Benefits Summary We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MA - Cambridge - Kendall Square - 500 U.S. Hourly Wage Range: $21.00 - $46.00 The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. internship benefits vary by location and may include: * Paid sick time * Civic Duty paid time off * Participation at company volunteer events * Participation at company sponsored special events * Access to on-site fitness center (where available) * Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - MA - Cambridge - Kendall Square - 500 Worker Type Employee Worker Sub-Type Paid Intern (Fixed Term) (Trainee) Time Type Full time Job Exempt No It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology, we collaborate to discover the next medical breakthrough. The Biologics Analytical Research & Development department of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Rahway, New Jersey research facility. The Associate Principal Scientist is a laboratory-based scientific role tasked with solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of Biologics drug substances and drug products. The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. The qualified candidate will be responsible for development, qualification, implementation, troubleshooting and transfer of analytical methods for monoclonal proteins or other complex therapeutic proteins. Responsibilities include development of new assay platforms, benchmarking current approaches/techniques to industry standards, and providing technical leadership of design of experiments and data interpretation. Applicants must have effective organizational, multi-tasking, oral/written communications skills, show scientific leadership, and a desire to conduct research and publish. Experience leading small groups of technical personnel and analytical projects will aid in distinguishing candidates. Evidence of strong cross-functional collaboration in an academic or industrial setting is also preferred. **Qualifications** **Education:** + B.S. in Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, or related field with 10+ years of relevant experience. + or master's degree with 7+ years of relevant experience. + or Ph.D. with 3+ years of relevant experience. **Required Experience and Skills:** + Strong background and experience in separations science + Extensive experience with UPLC/HPLC analysis of biologics (e.g. SEC, RP, IEX) and/or experience with capillary electrophoresis (CE) analysis of biologics (e.g. CE-SDS, iCIEF) + Extensive experience with process- and impurity-related residual assay development using molecular biology and immunoassay techniques. + Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications. + Ability to design, execute and/or direct the development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development. + A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays. Plan assay optimization and documentation to meet program deadlines. + Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications. + Experience with matrix management and peer to peer coaching. + Accurately and efficiently documentation of experiments + Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment. **Preferred Experience and Skills:** + Understanding of protein degradation mechanisms and link between analytical methodologies for analysis. + Experience with qualification, validation, and transfer of assays to a GLP or regulated laboratory environment as listed in ICH Q2 and USP. + Experience in representing analytical functional area on project teams. + Experience with complex glycan analysis and link to mechanisms of actions. + Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein) + Experience in data analytics, programming, or laboratory automation. \#AR&D **Required Skills:** Accountability, Accountability, Adaptability, Analytical Method Development, Antibody Drug Conjugates (ADC), Assay Development, Biological Assay Development, Biopharmaceutics, Biostatistics, Capillary Electrophoresis (CE), Cell-Based Assays, Chromatographic Techniques, Communication, Cross-Functional Teamwork, External Collaboration, Gel Electrophoresis, High Resolution Mass Spectrometry (HRMS), Immunochemistry, Liquid Chromatography-Mass Spectrometry (LC-MS), Mass Spectrometry Analysis, Optimistic Attitude, Process Analytical Technology (PAT), Protein Analysis, Scientific Research, Team Management {+ 3 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $139,600.00 - $219,700.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company 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. **Employee Status:** Regular **Relocation:** Domestic/International **VISA Sponsorship:** Yes **Travel Requirements:** 10% **Flexible Work Arrangements:** Not Applicable **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** N/A **Job Posting End Date:** 11/28/2025 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R372530

R3 Under the general supervision of a senior staff member in Center for Mathematical Sciences (CMS), the incumbent is responsible for the statistical analysis and evaluation of data to meet the needs of our company's Manufacturing Division. The individual will, through consultation with employees and teams, provide statistical expertise on experimental design, and the evaluation and interpretation of data. As required, the incumbent will evaluate data for submission to regulatory agencies and pharmacopoeia. **Primary Activities** + Partner with manufacturing teams to define clear objectives, success criteria, and decision points for process studies; select fit-for-purpose tools (e.g., ANOVA, ANCOVA, mixed-effects models). + Design and analyze experiments using Design of Experiments (DoE) to understand, optimize, and qualify/validate vaccine manufacturing processes and analytical methods. + Support scale-up, technology transfer, and comparability with sound protocols, acceptance criteria, and statistical justifications. + Analyze stability and shelf-life studies aligned with International Council for Harmonisation (ICH) guidance; perform degradation modeling, trend analysis, and shelf-life estimation using regression, mixed-effects models, and tolerance/prediction intervals. + Establish and maintain ongoing monitoring using Statistical Process Control (SPC) and Continued Process Verification (CPV) for Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs); implement control charts (e.g., X-bar/R, Individuals-Moving Range), capability analysis (Cp/Cpk/Pp/Ppk), and nonparametric trend tests as needed. + Troubleshoot issues, including Out-of-Specification (OOS) and Out-of-Trend (OOT) results, using data analysis, root-cause hypotheses, and targeted confirmation studies; apply multivariate methods (e.g., PCA, PLS) and Monte Carlo simulations for risk and sensitivity analysis. + Translate results into practical recommendations for setpoints, ranges, sampling plans, and control strategies; based on risk and uncertainty. + Develop reproducible, auditable analysis using good manufacturing/documentation practices. + Prepare clear statistical content for Chemistry, Manufacturing, and Controls (CMC) documentation; assist with regulatory queries using sound statistical rationales. **Minimum Education Requirements and Experience:** + Bachelor of Science (BS) in statistics or related field with ten (10) years of required experience, **OR** + Master of Science (MS) in statistics or related field with five (5) years of required experience, **OR** + PhD in statistics or related field with no required experience. Please note: Coursework and/or experience should include industrial statistics (DOE, SPC, regression, general linear models, and multivariate methods, computer programming). **Required Skills and Experience:** + A statistician experienced working in a pharmaceutical company dedicated to supporting vaccine manufacturing, emphasizing critical thinking, domain knowledge, and scientific partnership. + Demonstrated experience supporting Chemistry, Manufacturing, and Controls (CMC) activities for drug substance and drug products, including stability studies, comparability assessments, process validation, and control strategy development aligned with ICH guidelines + Working experience with Bayesian statistical framework + Background in mammalian cell culture and yeast fermentation + Proficient in live virus potency (plaque assays, TCID50, qPCR/dPCR) and recombinant protein analytics (ELISA, HPLC/UPLC). + Excellent statistical computing skills with substantial experience in at least two of the following statistical software packages: SAS, R, JMP, Minitab. + Hands-on experience with Design of Experiments (DoE), Analysis of Variance (ANOVA), Analysis of Covariance (ANCOVA), mixed-effects models, response surface methods, process capability, Statistical Process Control (SPC), Continued Process Verification (CPV), tolerance intervals, equivalence/non-inferiority testing, and Monte Carlo simulations + Strong consulting skills with the ability to work independently and collaboratively across cross-functional teams. + Excellent oral and written communication skills; able to explain statistical concepts and results to non-statisticians and influence decision-making + Proven leadership with advanced problem-solving and decision-making skills; adept at managing multiple projects, meetings, time, and priorities + Ability to think originally and creatively to develop practical, high-impact solutions and to persuade and motivate others toward adoption **Required Skills:** Accountability, Accountability, Bayesian Statistics, Business Intelligence (BI), Capability Analysis, Cell-Based Assays, Cell Cultures, Computer Programming, Control Charts, Data Analysis, Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning (ML), Mammalian Cell, Mammalian Cell Culture, Manufacturing, Manufacturing Processes, Manufacturing Support, Mixed Models, Response Surface Methodology, SAS Language, Software Development {+ 9 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $126,500.00 - $199,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company 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. **Employee Status:** Regular **Relocation:** Domestic **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Not Applicable **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** N/A **Job Posting End Date:** 12/11/2025 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R373127

Our Engineers support internal manufacturing operations to ensure they remain operational, and continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation. Position Description: Positions consists of the Automation/MES, Deviation Management, Manufacturing Technical Operations, Validation, New Product Technical Transfer Departments, Supply Chain Management, Quality, and other areas at the Durham Site. The Associate Specialist role will support one of the aforementioned Departments. The Durham Site contains a team of dedicated individuals who strive to understand, monitor, improve and support the transfer of our manufacturing processes. Within these groups, there are opportunities to support day-to-day activities and strategic projects to ensure the Durham Bulk and Formulation/Filling facilities operate Right-First-Time in a cost-effective manner, and to ensure on-going Technical Transfer activities to the site meet the financial and timeline requirements for the vaccine programs. This role requires daily problem solving with other Technical CoE groups, Operations, and Quality. The successful candidate will be expected to be a first responder to requests from the manufacturing areas when support is needed from their respective field. The well-qualified candidate must have analytical, problem-solving, and communication skills. In this role, the candidate will provide support for the manufacturing of aseptic products. Furthermore, the candidate will be required to work in a fast-paced environment. Some roles may require full-time shift assignments, and some roles may require temporary shift assignments to support critical projects or manufacturing steps. Responsibilities include but are not limited to: Accountable for delivering on Durham manufacturing objectives Accountable for providing technical support to Durham current and pipeline vaccine manufacturing Lead technical and business system process improvement projects Lead troubleshooting and resolution of unplanned events to ensure a reliable supply of Durham manufactured vaccines Author technical documentation Education Minimum Requirement: Bachelor's Degree or higher in Engineering or Sciences by Dec 2025 or May/Jun 2026 Required Experience and Skills: Ability to perform aseptic gowning during the execution of job duties Strong leadership, interpersonal and communication skills (written and oral) are required Preferred Experience and Skills: Knowledge of Lean Six Sigma practices and methods Knowledge of aseptic processing operations Knowledge of data analysis #SD2025 #FTP2026 Required Skills: Aseptic Processing, Aseptic Processing, Business Process Re-Engineering (BPR), Contractor Oversight, Driving Continuous Improvement, Engineering Standards, Equipment Qualification, Estimation and Planning, Fast-Paced Environments, GMP Compliance, GMP Validation, Healthcare Innovation, Lean Manufacturing, Lean Six Sigma (LSS), Maintenance Management, Manufacturing Processes, Manufacturing Quality Control, Manufacturing Scale-Up, Process Control, Process Optimization, Process Scale Up, Production Management, Production Operations, Quality Management, Supply Change Management {+ 2 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company 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. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 11/17/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** Takeda is committed to innovation, efficiency, and continuous improvement. We believe in empowering our team members with the tools, skills, and resources they need to excel. As part of our Global Regulatory Affairs (GRA) Operations team, you will collaborate with stakeholders across Research & Development departments to deliver projects that drive meaningful results for both our personnel and our patients. Embark on a transformative journey where your curiosity meets innovation, and your ambition catalyzes organizational growth. As the business landscape continues to evolve, the ability to adapt and enhance processes through intelligent technology becomes paramount. We are searching for forward-thinking individuals eager to make a tangible impact by marrying project management expertise with cutting-edge solutions. If you thrive in dynamic environments and are driven by the prospect of contributing to a culture of continuous improvement, your next opportunity begins here. Are you passionate about streamlining business operations, leveraging technology for organizational success, and applying your project management skills to real-world challenges? We invite highly motivated students with a background in project management, business administration, information technology, or related fields to join Takeda's Global Regulatory Affairs (GRA) Operations team as a Summer Intern. In this role, you will play a key part in optimizing key business processes and supporting the application of technology solutions to improve our team's knowledge management capabilities across various MS Office applications (SharePoint, Project, Excel, OneNote, etc.). **How You Will Contribute:** As a GRA Operations Project & Process Specialist Intern, you will have the opportunity to develop competency, build capability, and deliver results in the following areas: + Project Management Support: Assist in planning, executing, and monitoring business process improvement initiatives. Collaborate with project teams to define objectives, create timelines, track progress, and ensure deliverables are met. + Process Documentation: Analyze existing business workflows, identify gaps or inefficiencies, and help document new or improved processes using standardized methodologies. + Technology Solutions Implementation: Work with teams to deploy, configure, and optimize various software applications. Support migration of content and ensure effective categorization, tagging, and access controls. + Stakeholder Engagement: Communicate with internal stakeholders to gather requirements, provide updates, and facilitate training sessions or workshops on new technologies and procedures. + Change Management: Contribute to the development of communication and training materials to support adoption of new business processes and technology solutions. + Performance Measurement: Help establish key performance indicators (KPIs) and assist in the collection and analysis of data to measure the success of process improvements. + Continuous Improvement: Research best practices in project management, process optimization, and knowledge management, and recommend enhancements or new tools for optimizing organizational efficiency. You will have the opportunity to contribute specifically by: + Attending routine 1-1s and progress meetings with project teams. + Reviewing current business processes and assisting in mapping workflows using tools such as Visio. + Supporting the consolidation of legacy documentation and knowledge repositories within SharePoint, establishing metadata and versioning standards, and ensuring standards are followed. + Drafting training guides, quick reference sheets, and internal communications to support process and technology rollouts. + Helping manage project trackers, status reports, and meeting notes. + Responding to queries and provide troubleshooting assistance related to knowledge management platforms. + Documenting lessons learned and share feedback with the team to support continuous improvement efforts. + Preparing and delivering a "My GRA Summer" synopsis of the intern experience, recommendations for future interns, key takeaways, etc. **Internship Development Opportunities:** + Gain hands-on experience in project management and process optimization within a dynamic organization. + Participate in the deployment and enhancement of technology solutions, especially SharePoint knowledge management repositories. + Develop your skills in documentation, stakeholder engagement, and change management. + Learn to translate business requirements into actionable process improvements and technology implementations. + Interact and network with professionals across departments and disciplines. + Build a portfolio of real-world projects demonstrating your impact and value as a future project management professional. Join Takeda's Global Regulatory Affairs Operations team in Summer 2026 to: + Make a tangible impact by shaping how our organization manages information and delivers projects. + Work with experienced professionals who will mentor and support your growth. + Develop a robust understanding of how technology and process management intersect to drive business success. + Set yourself apart as a future leader in project management, business process analysis, and technology integration. **Job Requirements:** + This position will be fully remote + Must be pursuing a Masters Degree in Business Administration, Project Management, Information Systems, or a related field + Demonstrated understanding of project management principles and methodologies (e.g., Agile, Waterfall, Lean, Six Sigma). + Basic understanding of data analysis and visualization. + Experience in business process analysis and documentation. + Familiarity with technology platforms such as SharePoint, Microsoft Office applications (e.g., Word, PowerPoint, Excel, SharePoint, Teams, Copilot), and other enterprise collaboration and AI tools. Advanced SharePoint experience preferred. + Excellent communication, organizational, and interpersonal skills. + Analytical mindset with attention to detail and a proactive approach to problem-solving. + Ability to organize information logically and present findings clearly. + Ability to work independently as well as part of a cross-functional team. + Willingness to learn, ask questions, and adapt to evolving project needs. + Professionalism, reliability, and a collaborative spirit. + Previous internship or project experience in a business or technology setting is required. **Internship Eligibility** + Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship + Must be currently enrolled in a degree program graduating December 2026 or later + The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st) + The intern must be able to commit to one of these time frames + Able to work full time 40 hours a week during internship dates + Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program **Program Highlights:** + Hands-on experience with real projects and responsibilities + Dedicated mentorship program pairing interns with experienced professionals + Networking opportunities with industry professionals and fellow interns + Internship events focused on professional and skills development + Exposure to multiple business areas or departments within a Pharmaceutical Organization **Applications will be accepted between** **October 31st- November 16th** **Takeda Compensation and Benefits** **Summary** We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. **For Location:** Massachusetts - Virtual **U.S. Hourly Wage Range:** $21.00 - $46.00 The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. internship benefits vary by location and may include: + Paid sick time + Civic Duty paid time off + Participation at company volunteer events + Participation at company sponsored special events + Access to on-site fitness center (where available) + Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking. **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** Massachusetts - Virtual **Worker Type** Employee **Worker Sub-Type** Paid Intern (Fixed Term) (Trainee) **Time Type** Full time **Job Exempt** No It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. \#LI-Remote

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations. How you will contribute: · You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team. · You will screen new and repeat donors and take and record donor vital signs and finger stick results. · You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation. · You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures. · You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays. What you bring to Takeda: · High school diploma or equivalent · Ability to walk and/or stand for the entire work shift · Will work evenings, weekends, and holidays · Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees · Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. · Fine motor coordination, depth perception, and ability to hear equipment from a distance · Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear · 1 or more years minimum experience working in a customer or patient facing role is helpful What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MD - Forestville U.S. Starting Hourly Wage: $19.00 The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - MD - ForestvilleWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt No

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** RPM&SP partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for programs / products of high complexity are established and maintained, and plans & directs the seamless execution of the GRT goals. Oversees and provides regulatory operational support for programs in the Therapeutic Area Unit (TAU). Expertly leads cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for highly complex, novel, and critical programs by providing expert and effective Project Management leadership, oversight, direction and planning _._ The intern will support the Gastrointestinal (GI) Global Regulatory Project Management & Strategic Planning (RPM&SP) group in advancing regulatory milestones. This role will provide hands-on experience in health authority meeting planning, developing submission timelines, and supporting scenario planning for key regulatory deliverables. **How You Will Contribute:** The RPM&SP intern will provide valuable support in developing timelines, scenario analyses, and health authority meeting logistics-activities that directly impact the group's ability to meet regulatory milestones efficiently. The intern contribution will help in assisting the lead RPM to focus on strategy while ensuring operational excellence. In addition, the intern's fresh perspective and analytical work will enhance the team's ability to anticipate challenges and optimize submission planning Responsibilities **:** + Assist in planning and logistics for health authority (HA) meetings, including preparation of timelines, coordination of materials, and tracking key actions. + Support the development of submission timelines and scenario analyses to evaluate regulatory strategy options. + Contribute to the preparation of regulatory documentation and project tracking tools. **Internship Development Opportunities:** The intern will gain hands-on exposure to the regulatory strategy and operations function within Takeda's GI therapeutic area. By supporting health authority meeting preparation and submission planning, the intern will learn how cross-functional teams collaborate to advance innovative therapies through regulatory milestones. This role provides practical project management and regulatory operations experience that builds a strong foundation for a career in global drug development. **Job Requirements:** + This position will be Fully Remote + Currently pursuing a Bachelor's or Master's degree in Life Sciences, Regulatory Affairs, Pharmacy, or related field. + Strong organizational, analytical, and communication skills. + Interest in regulatory strategy, drug development, and project management. + Proficiency with Microsoft Office (Excel, PowerPoint, Project/Timeline tools a plus). **Internship Eligibility** + Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship + Must be currently enrolled in a degree program graduating December 2026 or later + The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st) + The intern must be able to commit to one of these time frames + Able to work full time 40 hours a week during internship dates + Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program ** ** **Program Highlights:** + Hands-on experience with real projects and responsibilities + Dedicated mentorship program pairing interns with experienced professionals + Networking opportunities with industry professionals and fellow interns + Internship events focused on professional and skills development + Exposure to multiple business areas or departments within a Pharmaceutical Organization Applications will be accepted between November 7th - November 30th **Takeda Compensation and Benefits** **Summary** We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. **For Location:** Boston, MA **U.S. Hourly Wage Range:** $21.00 - $46.00 The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. internship benefits vary by location and may include: + Paid sick time + Civic Duty paid time off + Participation at company volunteer events + Participation at company sponsored special events + Access to on-site fitness center (where available) + Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking. **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** Boston, MA **Worker Type** Employee **Worker Sub-Type** Paid Intern (Fixed Term) (Trainee) **Time Type** Full time **Job Exempt** No It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** The intern in the Early Clinical Development (ECD) computational biology group at Takeda GI-TAU will implement and test machine learning/deep learning based methods, to integrate and analyze large screening datasets and metadata information to generate actionable insights and interpretation for drug discovery and development questions in Gastrointestinal & Inflammation Therapeutic Area **How You Will Contribute:** As a Computational Biology Intern, you will have the opportunity to... + Leverage proprietary clinical multi-omics data assets and implement advanced AI/ML approaches. + Explore and experiment with innovative strategies for data integration, visualization, and analytical approaches. + Engage in the exploration of cutting-edge methodologies aimed at enhancing the precision and depth of analyses. + Contribute to the development of advanced techniques within the field of Precision Medicine and Biomarker Discovery. **Job Requirements:** + This position will be Fully Remote out of the Round Lake, Illinois location + Must be pursuing a Doctoral Degree in Computational Biology, Bioinformatics, Biostatistics and any other relevant fields. + Familiar with machine/deep- learning frameworks/libraries. Experience in testing and implement different deep learning architecture is preferred + Strong programming skills in R/Python. Proficiency in Unix/Linux shell, AWS/HPC environment is preferred + Working knowledge in molecular biology and clinical metadata + Highly motivated with a strong interest in bioinformatics data analysis in drug discovery and development + Quick learner, Outstanding oral and written communication skills. **Internship Eligibility** + Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship + Must be currently enrolled in a degree program graduating December 2026 or later + The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st) + The intern must be able to commit to one of these time frames + Able to work full time 40 hours a week during internship dates + Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program ** ** **Program Highlights:** + Hands-on experience with real projects and responsibilities + Dedicated mentorship program pairing interns with experienced professionals + Networking opportunities with industry professionals and fellow interns + Internship events focused on professional and skills development + Exposure to multiple business areas or departments within a Pharmaceutical Organization **Applications will be accepted between** **October 31** **st** **- November 16** **th** **Takeda Compensation and Benefits** **Summary** We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. **For Location:** USA - MA - Cambridge - Binney St **U.S. Hourly Wage Range:** $21.00 - $46.00 The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. internship benefits vary by location and may include: + Paid sick time + Civic Duty paid time off + Participation at company volunteer events + Participation at company sponsored special events + Access to on-site fitness center (where available) + Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking. **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** USA - MA - Cambridge - Binney St **Worker Type** Employee **Worker Sub-Type** Paid Intern (Fixed Term) (Trainee) **Time Type** Full time **Job Exempt** No It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job DescriptionAbout the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level. Supporting diverse modalities-including small molecules, biologics, and external manufacturing sites-the role employs an agile approach to drive standardization, scalability, and sustainability. This position leverages ICH Q12 principles to streamline post-approval change management and explores automation to enhance predictability and repeatability in regulatory processes. We are looking for someone with strong practical experience with global HA requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Who has a proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. How you will contribute: Lead site-specific post-approval change management activities, including record evaluations and regulatory submissions (considering possible strategic bundling of changes), ensuring compliance with global requirements. Apply science- and risk-based approaches, guided by ICH Q12 principles, to assess and implement post-approval changes. Drive the adoption of standardized processes and tools to enhance predictability, scalability, and sustainability in site-based regulatory activities. Explore and implement automation technologies to increase efficiency and ensure repeatability in change control and regulatory submissions. Provide centralized regulatory support for multiple manufacturing sites, including external partners, covering small molecules and biologics. Collaborate with external manufacturing sites and suppliers to align change control processes with global regulatory expectations. Ensure site compliance with global regulatory requirements by evaluating and prioritizing changes based on risk and scientific rationale. Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global Regulatory CMC in cross-functional Change Review meetings. Implement streamlined workflows for regulatory change control, leveraging digital tools and automation to minimize delays and maximize impact. Promote sustainable practices and scalability in site-level regulatory operations. Minimum Requirements/Qualifications: BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred. 10+ years of overall biopharmaceutical/device industry experience with 8+ years of direct Regulatory CMC or Regulatory Device experience required. This can include experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Strong practical experience with global HA requirements, beyond EU/US. Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. Analyze issues with attention to detail. Ability to assess alternative approaches. Proven ability to develop global regulatory strategy recommendations based on precedents and other regulatory intelligence as well as regulations and guidelines. Able to deal with issues of critical importance with minimal oversight. Exercises good judgment in elevating and communicating actual or potential issues to line management. Understands who is responsible for different decisions and escalates as necessary. Applies directions taken by the company. Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork. Intentionally promotes an inclusive culture. Applies given prioritization framework with limited support. Excellent written and oral communication skills required. Excellent skills in leadership, collaboration, negotiation, problem solving, and fostering interpersonal connections through teamwork. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $174,500.00 - $274,230.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Our company's Pharmaceutical Sciences organization translates molecules to medicines, working from the discovery interface through registration stability manufacturing by designing, developing and scaling up the formulation, device, and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing Practice (GMP) manufacturing facilities, our Scientists use cutting edge science to transform drug delivery and manufacturing technology to positively impact patients. The successful candidate will be a passionate Scientist with strong academic fundamentals and a drive to develop new medicines to improve human health. In this role, the individual will be responsible for supporting the formulation development of new chemical entities as part of a matrix team from initial first in human formulations (suspensions, solutions, capsules, tablets) through final market formulation definition and manufacturing process robustness assessment. **Primary Responsibilities:** + Propose new, innovative approaches for product development, generate experimental designs, execute experimental plans and interpret data. + Support internal capability development by evaluating new technologies and deploying them to pipeline assets. + Collaborate effectively within and across functional areas and possess advanced knowledge or experience in a specialized scientific area. The desired individual is someone who will bring knowledge and creativity to the position as well as have the discipline to drive results. + Execute formulation and process development activities using Design of Experiments for new chemical entities or life cycle management opportunities. + Coordinate development activities with process chemistry, preformulating, analytical, and physical characterization groups. + Outsource/coordinate formulation development or clinical manufacturing at Clinical Research Organization/Contract Manufacturing Operation. + Facilitate manufacturing, packaging and release of clinical supplies for clinical studies, assist in scale up activities at pilot and commercial scale, and summarize results in technical reports and presentations. + Enhance our professional image and competitive advantage through patents, presentations, publications and professional activities and advance areas such as science and technology development, technical and business strategic improvements, business process innovations. + Maintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with others. **Education Minimum Requirements:** + Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline. Bachelor of Science (B.S.) or Master of Science (M.S.) degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 6 years' relevant industrial experience. **Required Experience and Skills:** + Proven ability to identify and develop innovative ideas. + Demonstrated ability to independently design and execute complex experiments and data analysis. + Ability to work effectively with team-members of diverse skill sets and backgrounds. + Strong verbal and written communication skills. **Preferred Experience and Skills:** + Pharmaceutical development experience. + Demonstrated ability to identify, fundamentally characterize and address manufacturing challenges through the development and optimization of novel production technologies. + Experience with advanced drug product manufacturing technologies, including continuous manufacturing, Three-Dimensional (3D) printing, controlled release and/or oral delivery of large molecules. + Experience with process modeling, simulation and automation integration in the pharmaceutical and/or industrial manufacturing sector. + Desire to build new capabilities through the evaluation of new technologies and hands-on optimization of existing technologies. + Demonstrated ability to apply the principles of physical/organic chemistry, physical pharmacy and materials science to solving practical pharmaceutical development problems. + Hands-on experience in pharmaceutical pilot plants. *shift assignments may vary at company's discretion* \#eligibleforerp **Required Skills:** Accountability, Accountability, Adaptability, Biomedical Engineering, Biomedical Sciences, Bioprocessing, Business Processes, Chemical Engineering, Cross-Functional Teamwork, Data Analysis, Drug Delivery Technology, Flow Cytometry, High-Throughput Screening, Immunochemistry, Industrial Sectors, Innovation, Innovative Thinking, Interpersonal Relationships, Machine Learning, Molecular Biology Techniques, Multi-Color Flow Cytometry, Organic Chemistry, Pharmaceutical Development, Pharmaceutical Manufacturing, Preformulation {+ 5 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $114,700.00 - $180,500.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company 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. **Employee Status:** Regular **Relocation:** Domestic **VISA Sponsorship:** Yes **Travel Requirements:** 10% **Flexible Work Arrangements:** Not Applicable **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** No **Job Posting End Date:** 12/1/2025 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R372447

Our Clinical Research and Pharmacovigilance team pushes the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. The Clinical Director is responsible for protocol development and medical/ scientific oversight of clinical research studies involving new or marketed drugs in the Vaccines Clinical Research group. They will be responsible for all phases of the trial process, including but not limited to the design, oversight and medical monitoring of Phase I to V clinical trials, preparation of progress reports and summaries regarding vaccine safety and efficacy, as well as analysis, interpretation, and reporting of final clinical trial results. In addition to responsibilities associated with clinical research, the Clinical Director at this level will be expected to lead a Product Development Team (PDT) through late-phase clinical development and into post-licensure life-cycle management. This role demands scientific depth, strategic leadership, and the ability to operate at the highest level within a diverse, cross-functional organization. As PDT Leader, the incumbent will be accountable for developing and executing integrated development plans that align clinical, medical affairs, commercial, manufacturing, regulatory, analytical, and epidemiological disciplines to ensure cohesive program execution and optimized product value throughout its lifecycle. Responsibilities also include the presentation of research findings at national and international scientific meetings and preparation of manuscripts for publication in peer-reviewed journals. The Clinical Director will also contribute to establishing Vaccine Clinical Development Strategies and executing short- and long term research objectives. They will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion leaders. **Education:** + MD or MD/PhD **Required Experience and Skills:** + Minimum of 3 years of clinical medicine experience + Minimum of 5 years of industry experience in drug development with demonstrated success in overseeing multiple studies and protocols through completion + Experience in authoring regulatory documents and leading discussions with regulatory agencies + Demonstrated record of scientific scholarship and achievement + Proven track record in clinical medicine and background in biomedical research + Outstanding interpersonal and collaborative skills, as well as the ability to function in a matrix environment + Excellence in delivering clear, impactful communication verbally, in writing, and during presentations **Preferred Experience and Skills:** + Board-certified or eligible in a vaccine-related clinical field such as Internal Medicine, Obstetrics-Gynecology, Family Medicine, or Pediatrics. + Prior specific experience in clinical research and prior publication record **Required Skills:** Clinical Development, Clinical Studies, Clinical Trials, Clinical Trials Monitoring, Collaborating, Cross-Functional Teamwork, Drug Development, Leadership, Scientific Leadership, Vaccine Development, Vaccine Safety **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $304,800.00 - $479,800.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company 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. **Employee Status:** Regular **Relocation:** **VISA Sponsorship:** **Travel Requirements:** **Flexible Work Arrangements:** Hybrid **Shift:** **Valid Driving License:** **Hazardous Material(s):** **Job Posting End Date:** 11/21/2025 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R369584

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: This role is an integral member of the Daiichi Sankyo (DS) Global Regulatory Intelligence & Policy, Center of Excellence (GRIP CoE), and is responsible for leading US regulatory intelligence acquisition, analysis, communication, and knowledge management, as well as leading US regulatory advocacy and policy activities for assigned issue sets. The role will work closely with the Vice President, Head of North America Regulatory Affairs, other regional Regulatory Intelligence & Policy (RIP) Leads, and cross functional stakeholders, and will conduct analyses and targeted advocacy via a global lens that ensures US intelligence and policy activities are globally coordinated and globally aligned to achieve maximum impact for patients and Daiichi Sankyo business. Additionally, this role will be responsible for the management and continuous improvement of the GRIP CoE Hub designed to provide global access to critical RIP information and resources. Intelligence: The US RIP lead will: 1) Lead the acquisition, analysis, communication, and knowledge management of US regulatory intelligence (RI); 2) Interpret, analyze, and apply US regulatory intelligence to inform strategic decisions of asset teams and leadership, as well as to inform the development of DS policy positions; 3) Lead the strategic development and implementation of an assigned project portfolio (including the development of technology enabled systems, tools, processes, and key performance indicators) for identifying, analysing, and leveraging changes, trends, and other developments in the regulatory landscape, through a global lens, across all key markets where DS operates. The US RIP lead will leverage a wide variety of diverse internal and external sources, databases and networks, to interpret regulatory information into actionable insights that relate to DS's portfolio of development and marketed assets, and synthesize and communicate these findings to relevant cross-functional stakeholders, to help inform future DS regulatory/development strategies, activities and ways of working. Policy/Advocacy: The US RPI Lead will lead DS regulatory policy and advocacy activities for an assigned portfolio of policy topics. For assigned US issue sets, this role will be responsible for maintaining and efficiently and effectively communicating the current pulse of the issue, developing the DS US position, contributing to the development of Global Regulatory Affairs positions (and potentially serving as both the US and Global GRIP Lead on assigned topics), leading public commenting and other advocacy on assigned topics to ensure that DS has a voice in defining and shaping new or proposed FDA regulatory opportunities/changes/requirements (policy, regulations, guidance, pilots, workshops, etc.), and for preparing DS teams to efficiently navigate these changes to seize opportunities and to mitigate risk. Policy/advocacy activities will include but are not limited to partnering with regulators, interacting and influencing trade associations and other key external stakeholders, securing and executing opportunities to present and publish externally, briefing senior leaders, regulatory affairs teams, and other relevant functions, as well as contributing to the development and execution of assigned global regulatory policy activities. US Focus but with Global Lens/Mindset: While the core responsibilities are US focused, the US Lead will routinely engage with other regional leads and global subject matter experts in regulatory and other DS partner functions to ensure intelligence is analyzed via a global lens and that DS policy development considers the global environment and implications to maximize the impact of intelligence analysis and policy shaping activities. The US Lead may also serve as the global policy lead for specific assigned issues and will contribute to the GRIP CoE's global deliverables. The US Lead will also have a key role in cross-region mentoring and development activities. Stakeholder Engagement: The role will engage internal/external stakeholders from across functions on key regulatory topics, particularly related to biologics/oncology, including coordinating GRIP CoE activities with RA-CMC, R&D & corporate affairs as needed. Responsibilities: Regulatory Intelligence (RI) - Lead the monitoring, collection, synthesis, analysis, communication, archiving, and retrieval of key regulatory intelligence in a systematic manner for the US region, (and for a limited number of global issue sets driven by US FDA regulatory policy). - Transform regulatory information into actionable insights specific to Daiichi Sankyo, that will facilitate the rapid and efficient development and approval of Daiichi Sankyo medicines. - Contribute US regulatory intelligence content and perspective into deliverables (e.g., Quarterly GRIP Insight Reports, Ad Hoc GRIP CoE Alerts Notes; Quarterly Global SOP Committee Updates; and other fora as assigned). - Deliver insightful, proactive (e.g., from routine monitoring of priority issues) and responsive RI and analysis (e.g., in response to internal asset team and GRA Leadership queries), both through a global lens. - Leverage RI analyses to inform strategic decisions at both asset and above asset levels (e.g., using external/internal precedence, case studies, statements from regulators, etc.). - Leverage regulatory intelligence to inform the development and successful execution of Daiichi Sankyo regulatory policy goals. - Develop and maintain strong collaborative networks/relationships with cross-functional subject matter experts (SMEs) and Daiichi Sankyo partner functions that generate, analyze, and consume intelligence. - Leverage and maintain expert proficiency in the use of internal and commercial third-party RI tools, and mentor others to use. - Lead the development, implementation, maintenance, and continuous improvement of assigned elements of GRIP infrastructure (e.g., systems, tools, and processes) that enhance the efficiency and impact of the GRIP deliverables and team. - Contribute to the efficient global operation and continuous improvement of the GRIP CoE (e.g., key performance indicators, team meetings, mentoring, representing the GRIP CoE on cross-functional GRA and intel projects, vendor interactions). - Regulatory Policy Prioritization: - Identify and establish a focused set of US Regulatory Policy priorities for external engagement that are aligned with DS functions and leadership, and will have maximum positive impact on patients and accelerating the delivery of the DS portfolio. Horizon scan for emerging US regulatory policy topics; adjust priorities as needed. - Lead DS regulatory policy and advocacy activities for assigned portfolio of policy topics. For assigned issue sets: - Monitoring Communication: Efficiently and effectively monitor communicate the current pulse of priority issues to Daiichi Sankyo stakeholders via a global lens that includes global context and implications (e.g., briefings to senior leaders, including in advance of trade association interactions). Prepare Daiichi Sankyo teams to efficiently navigate policy/regulatory changes to seize opportunities and to mitigate risk. - Position Development: Develop US regulatory policy/position papers, in partnership with Daiichi Sankyo subject matter experts, ensuring alignment with key stakeholders internally to ensure a unified voice for subsequent Daiichi Sankyo advocacy. Lead or contribute to development and finalization of DS Global Positions. Potentially serve as both US Global GRIP policy lead on assigned topics. - Advocacy: Develop and execute strategic advocacy plans to achieve policy-shaping objectives for key policy topics, and grow the positive reputation of DS. Position paper messaging to drive policy shaping initiatives across multiple channels. Leverage and partner with Daiichi Sankyo cross-functional leaders and subject matter experts (e.g., from across RD, Safety, Tech/Supply and Commercial) to engage externally and increase the impact of DS advocacy. Engage with key external stakeholders including regulators and trade associations to advance and secure the adoption of the Daiichi Sankyo perspective on priority issues. Lead public commenting and other advocacy to ensure that Daiichi Sankyo has a voice in defining and shaping new or proposed FDA regulatory opportunities / changes /requirements (policy, regulations, guidance, pilots, workshops, etc.). Secure and execute opportunities for GRIP as well as other Daiichi Sankyo GRA and cross-functional leaders and subject matter experts to present and publish externally with regulators and/or other influential organizations. Reports back key insights to the GRA Leadership Team and other relevant stakeholders to inform strategic decisions. Tracks impact of advocacy efforts and applies learnings to continuously refine policy messaging and tactics to increase the impact and likelihood of success. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university): - Bachelor's degree in medicine, life sciences, health or related field required - Advanced degree E.g., Masters, Pharm.D., Ph.D., MD, JD preferred Experience Qualifications: - 7 or more years' experience in biopharma Regulatory Affairs, with at least 3 years developing regulatory strategies incl. successful delivery of regulatory projects submissions, and a working knowledge of US FDA regulations and guidelines regarding drug development, regulatory submissions and corresponding regulatory agency interactions required - 4 or more years' experience: 1) Leading and executing Regulatory Intelligence (RI) & Policy activities in the U.S., incl. monitoring, collecting, synthesizing, analyzing, communicating, and managing RI in a systematic retrievable manner for the US region, and 2) Leading and executing US Reg Policy activities, incl. partnering with regulators; coordinating engagement with and influencing trade associations and other key external stakeholders; securing and executing opportunities to present and publish externally; briefing senior leaders, regulatory affairs teams, and other internal relevant functions. Strong experience and working relationships across FDA and PhRMA highly desirable required - 1 or more years experience working with international teams; strong understanding of cross-cultural environments and different business practices across key markets preferred - 1 or more years experience of working with the global regulatory landscape for at least 2 of the following: Oncology drugs, Biologics/ADCs Companion diagnostics preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $189,520.00 - $284,280.00 Download Our Benefits Summary PDF

The District Manager (DM) is a first-line, field-based sales management role accountable for building a team of primary-care sales representatives. This includes hiring, training and deploying a motivated team with strong customer account management, product, and disease state knowledge who are responsible for generating sales and demand within his/her sales district. This position focuses on establishing customer relationships, maximizing sales performance, and implementing national sales strategies to achieve budget targets. The role requires strong leadership skills to coach and develop team members while ensuring compliance with company policies. The ideal candidate should have a strong knowledge base in primary-care sales and previous experience leading high-performing sales teams. This role will cover the Philly/DC territory. Ideal living locations for this position include Philadelphia, PA and Washington, DC. Responsibilities Hire, coach, develop and retain a high-performing team of primary care sales representatives utilizing available tools Deliver sales performance and relevant Brand Key Performance Indicators (KPIs) in order to meet or exceed district sales plan within expense budgets Oversee the daily in-field activity and day-to-day management of assigned team members to achieve results within specific district/geographical assignment Lead a field team of sales representatives ensuring that they are appropriately trained on product knowledge, market conditions, brand strategy and tactics, corporate policies, and targeted business planning Ensures team execution of territory account plans to achieve monthly, quarterly and annual product sales and launch objectives Optimize resource utilization by setting and monitoring sales performance targets, budgets, and managing Sales Force Management Systems and KPIs in order to continuously meet/exceed district sales performance Ensure district priorities, activities and engagement plans are aligned with brand strategy and national strategic priorities in order to optimize strategic momentum and drive brand success Directly contribute to the revenue and profit goals within the assigned district by ensuring sales goals are met and expenses are managed in a fiscally responsible manner Hold direct reports accountable to behaviors and expectations through consistent field visits, one-on-ones and performance check-ins Effectively plan and conduct plan of action and other meetings with members of Sales Leadership Regularly analyze and monitor team performance in order to optimize territory performance with direct accountability for achievement of targets Sets and maintains high standards with the team for compliance, product knowledge, brand messaging, digital resource utilization, competitor assessment, and selling skills Ensures that sales representatives effectively address performance gaps; work in close partnership with Regional Directors and HR to guide all disciplinary action Work closely with cross functional partners to plan and execute territory strategies to win account opportunities and achieve overall sales targets on a monthly and quarterly basis. Partners may consist of Medical, Market Access and Field Reimbursement, Account Management, Inside Sales as well as Marketing and Operations Plan, forecast, and oversee an operating budget while actively monitoring expenses Maintain required technical expertise to respond accurately to all questions regarding products, policies and business-related issues from customers and representatives Conduct field rides as directed by leadership and provide timely feedback, direction, and coaching to Sales Representatives Works cross functionally in development of POAs and National Sales Meetings, which includes meeting objectives, training workshops, participants, timing, agenda and post-meeting metrics (both quantitative and qualitative) Serves as a role model regarding the compliance of all laws and company policies and ensures that the activities of the regional team ethically and compliantly contribute to the achievement of the company's sales and profit objectives Participate in additional cross-functional launch readiness preparation as required Minimum Job Requirements BS/BA degree required Minimum of five (5) years of successful pharmaceutical sales experience with experience in the primary care space highly preferred Minimum of three (3) years of sales management experience in the pharmaceutical industry strongly preferred Proven track record of successful leadership, management and coaching of cross functional teams or functional individuals and teams Launch planning and experience strongly preferred, particularly in the primary care space Experience coaching total office call activity in a primary care or specialty setting utilizing all available company resources Experience leveraging knowledge and expertise to build strong relationships with HCPs, pharmacies and other key stakeholders Proven ability to understand disease states patient profiles and treatment pathways to articulate and routinely present clinical information Proven track record of documented sales success which includes meeting or exceeding territory performance goals and achieving national levels of recognition Proven ability to think strategically and work with a high level of integrity accuracy and attention to detail Experience in utilizing and optimizing CRM systems in support of territory dynamics and analyzing performance Demonstrates relentless drive for success by proactively identifying opportunities, overcoming obstacles, and turning over every stone to achieve district goals and elevate team performance Prior experience promoting newly launched products(s) strongly preferred Knowledge of territory and relationships with key stakeholders already established is a plus Marketing and other commercial experiences with an understanding of financial processes, Market Access, Project Management skills and knowledge of the Regulatory environment within biotech/pharma industry is a plus Competencies Possess strong presentation organization administrative and communication skills Excellent interpersonal skills with the ability to lead, interact with, focus, resolve conflict and drive consensus among individuals from a variety of cultures and disciplines Ability to set a vision, to lead change, and to coach/mentor others Proven ability to deliver candid effective feedback and efficiently manage performance Possesses solid knowledge and understanding of all assigned products, treatment regimens, competitor products, and market and industry trends Effective prioritization, flexibility and change management in a dynamic environment Focuses on customer excellence; actively seeks to discover and meet the needs of internal and external customers by building relationships and delivering innovative solutions Proactively takes ownership of situations with a can-do approach Advanced business analytical skills to identify trends opportunities and threats Ability to problem solve and determine actions to drive business or overcome challenges Ability to utilize corporate reporting tools and technology Other Requirements Complete full onboarding curriculum including clinical modules, CRM documentation, and fair balance call standards Pass live call certification and mock objections during ride-along training Attend refresher meetings on product and disease-state updates Significant field travel (approximately 80%) which can include some overnight and/or weekend travel Valid driver's license with a clean driving record and ability to pass a complete background check Must have valid licenses and credentialing required to conduct business in assigned territory Driving in a safe manner to required meetings and appointments Ability to drive or fly to target accounts, customers, meetings and conventions Additional Information The base salary range for this full-time, field-based position is $165,000- $215,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role. EEO Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory. If you are 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 use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling ************ or by sending an email to ***********************.

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. **Education and Minimum Requirement:** + Master's degree in statistics or related discipline with a minimum of 3 years relevant experience. + A minimum of 12 months' experience in large molecule drug substance process characterization. **Required Skills and Experience:** + This is a hands-on project facing position and must have demonstrated experience interacting with large molecule drug substance process characterization teams. + Must have demonstrated experience of effectively working remotely; Must be able to travel to Rahway site as business needs dictate. + Proven experience applying DOE to real-life large molecule drug substance process characterization problems. + Proven experience with large molecule drug substance process characterization study data management in structured database (e.g., RLIMS) + Proven experience of statistical analysis methodologies for mixed-effects models, including variable selection, and experimental design. + Proven experience generating simulations for PAR setting, generating impact ratios and other details for parameter classification. + Strong hands-on experience with JMP and working knowledge of other statistical and data processing software. + Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution. + Strong oral and written communication skills. Able to function effectively in a fast paced, team environment. Flexibility is critical. **Responsibilities:** + Willing to learn and use the internal computing platform. + Develop study design (DOE), statistical analysis, and reported output using in-house developed JMP tools in fast-paced, critical path projects. + Provide expert second statistician review of drug substance process characterization studies. + Participate on drug substance process characterization teams to understand requirements to design study experiments and discuss results. Experiment design entails having joint conversations with the Process scientists/engineers to discuss the issues and constraints on study design and execution. + Work with Process Scientists/Engineers to complete study reports as needed. BARDS2020 \#eligiblefor ERP **Required Skills:** Biostatistics, Communication, Data Analysis, Data Management, Data Science, Design of Experiments (DOE), Oral Communications, Process Characterization, Process Consulting, Process Research, Remote Workforce, SAS JMP (Statistical Software), Scientific Modeling, Scientific Study Design, Statistical Analysis, Statistical Design of Experiments (DOE), Statistics, Written Communication **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $114,700.00 - $180,500.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company 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. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** n/a **Job Posting End Date:** 11/19/2025 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R372754

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description RPM&SP partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for programs / products of high complexity are established and maintained, and plans & directs the seamless execution of the GRT goals. Oversees and provides regulatory operational support for programs in the Therapeutic Area Unit (TAU). Expertly leads cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for highly complex, novel, and critical programs by providing expert and effective Project Management leadership, oversight, direction and planning . The intern will support the Gastrointestinal (GI) Global Regulatory Project Management & Strategic Planning (RPM&SP) group in advancing regulatory milestones. This role will provide hands-on experience in health authority meeting planning, developing submission timelines, and supporting scenario planning for key regulatory deliverables. How You Will Contribute: The RPM&SP intern will provide valuable support in developing timelines, scenario analyses, and health authority meeting logistics-activities that directly impact the group's ability to meet regulatory milestones efficiently. The intern contribution will help in assisting the lead RPM to focus on strategy while ensuring operational excellence. In addition, the intern's fresh perspective and analytical work will enhance the team's ability to anticipate challenges and optimize submission planning Responsibilities: Assist in planning and logistics for health authority (HA) meetings, including preparation of timelines, coordination of materials, and tracking key actions. Support the development of submission timelines and scenario analyses to evaluate regulatory strategy options. Contribute to the preparation of regulatory documentation and project tracking tools. Internship Development Opportunities: The intern will gain hands-on exposure to the regulatory strategy and operations function within Takeda's GI therapeutic area. By supporting health authority meeting preparation and submission planning, the intern will learn how cross-functional teams collaborate to advance innovative therapies through regulatory milestones. This role provides practical project management and regulatory operations experience that builds a strong foundation for a career in global drug development. Job Requirements: This position will be Fully Remote Currently pursuing a Bachelor's or Master's degree in Life Sciences, Regulatory Affairs, Pharmacy, or related field. Strong organizational, analytical, and communication skills. Interest in regulatory strategy, drug development, and project management. Proficiency with Microsoft Office (Excel, PowerPoint, Project/Timeline tools a plus). Internship Eligibility Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship Must be currently enrolled in a degree program graduating December 2026 or later The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st) The intern must be able to commit to one of these time frames Able to work full time 40 hours a week during internship dates Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program Program Highlights: Hands-on experience with real projects and responsibilities Dedicated mentorship program pairing interns with experienced professionals Networking opportunities with industry professionals and fellow interns Internship events focused on professional and skills development Exposure to multiple business areas or departments within a Pharmaceutical Organization Applications will be accepted between November 7th - November 30th Takeda Compensation and Benefits Summary We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Hourly Wage Range: $21.00 - $46.00 The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. internship benefits vary by location and may include: Paid sick time Civic Duty paid time off Participation at company volunteer events Participation at company sponsored special events Access to on-site fitness center (where available) Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypePaid Intern (Fixed Term) (Trainee) Time TypeFull time Job Exempt NoIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

The Future Talent Program features Cooperative (Co-op) education that lasts up to 6 months and will include one or more projects. These opportunities in our Animal Health Division can provide you with great development and a chance to see if we are the right company for your long-term goals We're seeking a motivated Marketing Co-op to support go‑to‑market strategy, competitive positioning, and product launch activities. This 6-month role offers hands‑on experience working with product, sales, and marketing teams to translate product capabilities into compelling messaging, enable sales, and measure market impact. Ideal candidates are studying marketing, business, product management, communications, animal science or a related field. Key Responsibilities: Help develop product positioning and messaging tailored to buyer personas and use cases Support production of customer‑facing materials such as one‑pagers, FAQs, slide decks, website copy, and social media posts Perform market, customer, and competitive research to identify trends, differentiators, and gaps Analyze product usage and campaign performance to inform positioning and prioritization Create and maintain product collateral in the content repository and update product pages in CMS Track KPIs tied to product marketing (adoption, feature usage, etc.) and prepare reports Education: Current enrollment in a Bachelor's program in Marketing, Business, Communications, Product Management, Animal Science or related field Required Experience and Skills: Candidate must have strong written and verbal communication skills with attention to detail Candidate must have the ability to synthesize technical product information into clear, benefit‑focused messaging Candidate must have an analytical mindset; comfortable working with data in spreadsheets Candidate must have proficiency with Microsoft Workspace Candidate must have an interest in product strategy and customer‑facing communications Candidate must have the ability to manage multiple priorities and collaborate across teams Please note that this position may be closed before the posted end date or may remain open longer, at the discretion of the company. Salary range: The salary range for this role is $39,600.00-$105,500.00 USD FTP2026 AH2026 Required Skills: Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company 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. Employee Status: Intern/Co-op (Fixed Term) Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 11/19/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology, we collaborate to discover the next medical breakthrough. The Biologics Analytical Research & Development department of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Rahway, New Jersey research facility. The Associate Principal Scientist is a laboratory-based scientific role tasked with solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of Biologics drug substances and drug products. The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. The qualified candidate will be responsible for development, qualification, implementation, troubleshooting and transfer of analytical methods for monoclonal proteins or other complex therapeutic proteins. Responsibilities include development of new assay platforms, benchmarking current approaches/techniques to industry standards, and providing technical leadership of design of experiments and data interpretation. Applicants must have effective organizational, multi-tasking, oral/written communications skills, show scientific leadership, and a desire to conduct research and publish. Experience leading small groups of technical personnel and analytical projects will aid in distinguishing candidates. Evidence of strong cross-functional collaboration in an academic or industrial setting is also preferred. Qualifications Education: B.S. in Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, or related field with 10+ years of relevant experience. or master's degree with 7+ years of relevant experience. or Ph.D. with 3+ years of relevant experience. Required Experience and Skills: Strong background and experience in separations science Extensive experience with UPLC/HPLC analysis of biologics (e.g. SEC, RP, IEX) and/or experience with capillary electrophoresis (CE) analysis of biologics (e.g. CE-SDS, iCIEF) Extensive experience with process- and impurity-related residual assay development using molecular biology and immunoassay techniques. Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications. Ability to design, execute and/or direct the development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development. A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays. Plan assay optimization and documentation to meet program deadlines. Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications. Experience with matrix management and peer to peer coaching. Accurately and efficiently documentation of experiments Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment. Preferred Experience and Skills: Understanding of protein degradation mechanisms and link between analytical methodologies for analysis. Experience with qualification, validation, and transfer of assays to a GLP or regulated laboratory environment as listed in ICH Q2 and USP. Experience in representing analytical functional area on project teams. Experience with complex glycan analysis and link to mechanisms of actions. Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein) Experience in data analytics, programming, or laboratory automation. #AR&D Required Skills: Accountability, Accountability, Adaptability, Analytical Method Development, Antibody Drug Conjugates (ADC), Assay Development, Biological Assay Development, Biopharmaceutics, Biostatistics, Capillary Electrophoresis (CE), Cell-Based Assays, Chromatographic Techniques, Communication, Cross-Functional Teamwork, External Collaboration, Gel Electrophoresis, High Resolution Mass Spectrometry (HRMS), Immunochemistry, Liquid Chromatography-Mass Spectrometry (LC-MS), Mass Spectrometry Analysis, Optimistic Attitude, Process Analytical Technology (PAT), Protein Analysis, Scientific Research, Team Management {+ 3 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $139,600.00 - $219,700.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company 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. Employee Status: Regular Relocation: Domestic/International VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 11/28/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.