Jobs at Daiichi Sankyo
2,115 open positions
Data Engineer
Company: Daiichi Sankyo
Location: Other US Location
Posted Aug 16, 2023
The Data Engineer will partner with business stakeholders and decision makers to develop solutions to support their analytical needs and business insights. This role will be responsible for designing, developing, and maintaining the company's data architecture, data pipelines, and infrastructure to ensure the effective management, analysis, and utilization of data. The role will collaborate with IT, sourcing partners, data stewards, and business to ensure data integrity, and data security in accordance with business requirements and provide technical and data subject matter expertise where required.
Senior Scientist/Associate Director, RACMC
Company: Daiichi Sankyo
Location: Other US Location
Posted Aug 05, 2023
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. Education Qualifications (from an accredited college or university) Bachelor's Degree Life Science Degree requiredMaster's Degree preferredPharmD preferred Experience Qualifications 10 or More Years in the pharmaceutical industry with significant experience in scientific/regulatory fields preferredExperience in international Regulatory Affairs- CMC preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Promotes global RACMC services to CMC Operations, Pharmaceutical Development, and Clinical Supplies' Operations within the organization.Supervise the identification and compilation of required documentation for submission. Prioritizes workload.Evaluate content and adequacy of submissions and identify deficiencies. Prepare regulatory responses to requests from health authorities. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Responsibilities Organize and manage the preparation (content and format) of all types of submissions to FDA. Coordinates activities required for timely and accurate reporting of information to existing submissions.Facilitate and support liaison activities with functional groups within Daiichi Sankyo Pharma Development and Corporate partners related to assigned products/project areas.Provide regulatory support and guidance and manage regulatory submissionsKeep current with Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations. Determine the content for regulatory submissions as well as evaluate submissions for accuracy. Direct preparation of annual reports for both marketed and developmental products.
Manager, Data Management and Analytics
Company: Daiichi Sankyo
Location: Other US Location
Posted Aug 15, 2023
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. transparency, documentation, and QA. Must have experience leading / overseeing cloud-based enterprise technology platforms that support Integration, Master Data Management, and analytical platforms (i.e., Informatica IICS, Veeva Network, SAS). The individual in this role owns the support and technical design / development, testing / debugging, deployment, and manages the ongoing production operations of analytic dashboards, databases, applications, and integrations. This includes requirement gathering, design, development, and implementation of analytic, database, integration, and master data management solutions. - Collaborates with cross-functional teams (project stakeholders, integration, architecture, infrastructure teams, etc.) on development and deployment of analytic dashboards, databases, and applications. Education Qualifications (from an accredited college or university) - Bachelor's Degree in Computer Science or a related discipline required Experience Qualifications 3-5 years of experience with cloud-based Data Integration tools (MS Azure, Informatica IICS or equivalent) preferred preferred - 3-5 years of experience with enterprise scheduling / orchestration tools (Tidal Enterprise Schedule or equivalent) preferred preferred - 3-5 years of experience with enterprise Managed File Transfer tool (Cleo Harmony or equivalent) preferred preferred - 3-5 years of experience working with MS SQL Server DB, Azure SQL DB and SQL DB Managed Instance preferred preferred - 1-2 years of pharmaceutical background required required - Pharmaceutical Customer Master experience supporting Commercial Operations and Compliance needs preferred - Has a comprehensive understanding of data warehousing, ETL / ELT, dimensional modeling, normalization, indexing and partitioning preferred - Managing third-party vendors that support databases, advance analytical systems, data warehousing and manage data management systems. The individual will supervise onshore and offshore teams on the review, prioritization and resolution of data and technical issues. This role acts as a liaison between DSI IT and end-users, requires a strong understanding of commercial / sales operations and other key functions to better understand their needs and support ongoing production operations.
Manager, Digital Content
Company: Daiichi Sankyo
Location: Other US Location
Posted Aug 12, 2023
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. Education Qualifications (from an accredited college or university) - Bachelor's Degree required Experience Qualifications - 4 or More Years Experience in corporate, digital content, social media or public relations that includes direct responsibility for social media (and/or website) content development and strategy support required - 1 or More Years Experience in graphic design, social media analytics and video editing is highly preferred, 2+ years optimal required - 1 or More Years Experience in a highly regulated industry such as finance, technology, healthcare/pharmaceuticals, as well as social media crisis management preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. - Monitor internal social media request forms and processes for development, review and approval. - Track KPIs and channel metrics for social media and website. - Manage social media promotion and publishing of Corporate blog (Our Stories). - Review and facilitate all incoming social media content from business partners, manage traffic flow - via a social media editorial calendar -- and oversee quality control of content prior to publication. Responsibilities - Develop corporate social media posts and maintain social media presence, including community management and page moderation. - Collaborate productively with teams and individuals across businesses, and colleagues in peer functions, to advise, write, obtain approvals to execute strategic social media campaigns that align with key business objectives and corporate messaging. - Manage the ongoing social media editorial calendar, oversee scheduling in our publishing platform and accountable for all key organic engagement metrics. - Support publishing of news releases on DS.US - Serve as primary liaison with IT for website content updates.
Associate Director, Omnichannel Marketing
Company: Daiichi Sankyo
Location: Other US Location
Posted Aug 15, 2023
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. required - 1 or More Years Pharmaceuticals Experience including Sales, Marketing, IT or Market Access Leadership or other related area. Education Qualifications (from an accredited college or university) - Bachelor's Degree Marketing, Business Administration, or other related area preferred required - MBA Marketing, Business Administration, or related area preferred Experience Qualifications - 7 or More Years Overall related experience required - 4 or More Years Experience in developing and implementing digital/omnichannel marketing strategies. - Manage the day-to-day operations of Omnichannel Marketing for Brand team/s, including all budget-related, project management oversight and other issues. Partner with brand teams, key sales, operations and market access personnel, as well as other internal stakeholders to ensure digital, financial and strategic optimization. preferred Travel Ability to travel up to 20% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Ensure customer 360 lens is clearly understood by brand leadership, is incorporated into analytics, is compliant and validated. Evaluate and recommend new optimization methods to improve customer experience. Foster productive relationships with key senior customer decision makers. - Work with IT and external vendor partners to manage user experience across platforms, assisting with problem resolution.
Director, GMP QA Technical Operations
Company: Daiichi Sankyo
Location: Other US Location
Posted Aug 13, 2023
The text describes a leadership role in GMP Technical Operations for Daiichi Sankyo Group, focusing on establishing and managing robust governance, supporting product quality, and driving phase appropriate inspection readiness. The incumbent will work across multiple departments and products to ensure high-quality deliverables and regulatory compliance.
Manager, Omnichannel Marketing
Company: Daiichi Sankyo
Location: Other US Location
Posted Aug 20, 2023
Daiichi Sankyo, Inc. is seeking a Manager, Omnichannel Marketing with 4+ years of experience in digital/omnichannel marketing strategies, preferably in the pharmaceutical industry. The role involves supporting the development, planning, and implementation of omnichannel marketing strategies, assessing ROI and KPIs, and managing day-to-day operations. The individual will work closely with brand teams, IT, and external vendors to ensure seamless execution of all omnichannel platforms and tools. The company is committed to diversity and inclusion, and the role reports to the Director, Omnichannel Marketing.
Manager, Statistical Programming
Company: Daiichi Sankyo
Location: Other US Location
Posted Aug 12, 2023
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. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Responsibilities include contribute to CRF and SDTM standard development, support develop, implement, and maintain Analysis Data Model (ADaM) dataset and TLF standard, develop sample programs to generate standard ADaM dataset and TLFs, support training and ensure implementation of ADaM and TLFs standard in clinical trials analysis.Provide programming support to prepare regulatory requested analyses and help submission team in quick turnaround in response to regulatory agencies. Responsibilities include create TLFs to support submission QAs in a quick turnaround, support ad-hoc and exploratory analysis requested by clinical team, provide programming supports in agency response or potential Advisory Committee Meeting.Develop and maintain programming macros to effectively support internal data review and monitoring. Responsibilities include review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset specifications and ensure correct interpretation of SAP, develop independent programs to validate analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review submission data package and ensure its quality and integrity.Oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met. Responsibilities include: review and agree on vendor project timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs transfers for ongoing and complete trials, confirm data use and output quality, proactively ensure the resolution of programming related issues prior to database lock analysis, be accountable and verify completeness of study programming deliverables, maintain all required study programming documentation required for Trial Master File (TMF).Maintain institutional knowledge across oncology compounds and support building up oncology programming standard on datasets and TFLs to improve efficiency and quality. Education: (from an accredited college or university) Bachelor's Degree from an accredited institution in science or in a technical field preferredMaster's Degree preferred Experience Qualifications Qualifications: 7 or More Years proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with bachelor's degree preferred.4 or More Years proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with master's degree preferred.Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming preferred.Advanced working knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis preferred.Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials preferred.Having knowledge of all phases of drug development, including early and late phase clinical development and submission preferred.Having solid background of applied statistics preferred.Solid knowledge of new advanced statistical methods using SAS preferred.Knowledge in database structures and set-up preferred.The candidate should have successfully provided programming expertise at the Project level for at least two global development projects that have been submitted to regulatory agencies preferred. Responsibilities: By leading internal programming contractor or by self, perform programmatic review of analysis datasets and TLFs generated by statistical vendor, ensure deliverable quality for the pivotal studies, Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include work with Biostatistics member to define the requirements of efficacy data review, develop macros and support the internal data review and monitoring on an ongoing basis.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Summary The purpose of this job is to oversee statistical vendor deliverables, perform programmatic review of analysis datasets and Table, Listing, and Figures (TLFs) generated by vendor, ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission.
Associate Director, US HEOR
Company: Daiichi Sankyo
Location: Other US Location
Posted Aug 15, 2023
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. preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Education Qualifications (from an accredited college or university) Graduate degree or training in Health Economics, Pharmaceutical Administration, Biostatistics, Health Services Research, Clinical Epidemiology, Public Health Policy or similar discipline requiredPhD or MD with additional training in Health Economics preferred Experience Qualifications 4 or More Years experience in pharmaceutical industry preferredrelevant experience in contract research organizations or academic medical centers etc. preferred.Previous experience in Strategic Pricing and Reimbursement preferred.Previous experience in Cardiovascular and/or Metabolic Disorders and/or Oncology preferred.Previous experience in interacting with HTA agencies and Payer groups preferred.Previous experience in econometrics and/or database analysis preferred.Previous experience in clinical research or pharmaceutical marketing or marketing research preferred.strong econometric modeling and statistical analysis expertise; preferredefficiency with SAS and similar programs preferredProficiency in Microsoft Office Suite of Technologies; preferredWord, Excel, PowerPoint, Project etc. Where appropriate, lead project teams responsibility for the development and validation of new PRO instruments. Develop Value Maps for areas of therapeutic interest to Daiichi Sankyo. Provide input to clinical development and commercial planning activities. Partner with employers as necessary to measure the employee productivity benefits associate with Daiichi Sankyo products and programs.Accompany Medical/Outcomes Liaisons as necessary during strategic account presentations and/or research planning meetings to discuss health outcome research design and methodology issues and/or review product health outcomes data. Responsibilities Establish Daiichi Sankyo. Participant in in-licensing and indication sequence evaluations.
Manager, Study Associates
Company: Daiichi Sankyo
Location: Other US Location
Posted Aug 12, 2023
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. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. CRA experience preferred. The Manager, Study Associates will also manage contract staff, as required. 4 or More Years Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). Experience Qualifications: 4 or More years relevant experience is required with a BS required, MS preferred. Responsible for staff training, performance management, setting individual employee goals and career growth opportunities. Responsibilities: Supervise at team of 10-12 Study Associates.Participate in resume review, interviewing, hiring and onboarding of new staff.As part of Vendor Oversight, meet with contract agencies on a monthly basis to provide performance feedback for contract Study Associates, contract statuses, and discuss project timelines for current and future contract needs.Evaluate employee performance through study team feedback and established performance metrics and provide this feedback through regularly scheduled 1:1 meetings.Collaborate with Clinical Study Manager on SA deliverables.Participates in departmental and cross-functional process improvement initiatives, as required. Education Qualifications: (from an accredited college or university) Bachelor's Degree Bachelor's degree required.Master's Degree preferred. Physical Requirements: In-house office position that may require occasional travel 10% of Time.
Associate Director, Talent Management and Performance
Company: Daiichi Sankyo
Location: Other US Location
Posted Aug 05, 2023
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. Experience Qualifications: 4 or More Years experience in Human Resources, including knowledge of full cycle performance and talent management. preferredKnowledge of the Pharma industry preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Education Qualifications (from an accredited college or university) Bachelor's Degree in HR, Business Administration, Economics or a related field required.Advanced degree preferred. Partner with senior leaders to identify and manage high potential employees, key positions and mission critical talent.Lead the process design, facilitate and document the identification of key successors, critical talent and high potentials. Talent Management Process: Talent Assessment and Succession PlanningStrategic partner and thought leader about talent management processes and practices.Plan, develop and implement talent assessment and succession planning strategy and programs, building superior bench strength. Ensure the documentation of replacement, retention and development plans for these target groups. Responsibilities: Performance Management StrategyExecutes the organization's Performance Management Strategy. Partners with HRBPs and HR Systems to create business-appropriate solutions to drive adoption and utilization of the performance management process.Evaluate the results of the process and recommend improve, etc.Develop performance process metrics, recommend target distribution, etc. Monitors follow up of post talent review actions.
Senior Analyst, Statistical Programming
Company: Daiichi Sankyo
Location: Other US Location
Posted Aug 12, 2023
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. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Responsibilities include support developing, implement, and maintain Analysis Data Model (ADaM) dataset and TLF standards, develop/validate sample programs to generate standard ADaM dataset and TLFs, and develop and maintain programming macros to effectively support internal data review and data surveillance. Responsivities include create analysis dataset (including specifications) and TLFs to prepare submission, respond to agencies' questions, perform ad-hoc analysis requested by clinical team, provide programming supports in potential Oncology Drug Advisory Committee (ODAC).Support programming project lead to oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met. Responsibilities include: review and agree on vendor project timelines and resource planning as the backup of the programming project lead, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs transfers for ongoing and complete trials, confirm data use and output quality, proactively ensure the resolution of programming related issues prior to database lock analysis, maintain all required study programming documentation required for Trial Master File (TMF).Support building up DSI compound specific programming standard on datasets and TFLs to improve efficiency and quality. Responsibilities include review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data surveillance, review analysis dataset specifications and ensure correct interpretation of SAP, develop independent programs to validate analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review submission data package and ensure its quality and integrity.Provide programming supports for submission and help submission team in quick turnaround in exploratory analysis and response to regulatory agencies. Education/Qualifications: (from an accredited college or university) Bachelor's Degree an accredited institution in a science or in a technical field preferred.4 or More Years bachelor's degree with (or master's degree with minimum 2 years) proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming preferred.Advanced working knowledge of SAS programming language used in clinical trials programming preferred.Advanced working knowledge of CDISC ADaM, and extensive experiences of their implementation in clinical trials analysis preferred.Working knowledge of CDISC SDTM preferred.Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials preferred.Knowledge of drug development preferred.Experience in regulatory submission and support preferred.Solid background in applied statistics preferred.Solid knowledge of new, advanced statistical methods using SAS and R is a plus preferred.Knowledge in database structures and set-up preferred. Responsibilities: Perform programmatic review of analysis datasets and TLFs generated by statistical vendor, ensure deliverable quality for the pivotal studies and integrated analysis, and expedite the preparation of regulatory submissions. Summary The purpose of this job is to support quality assurance of statistical vendor deliverables, including performing programmatic review of analysis datasets and Table, Listing, and Figures (TLFs) generated by vendor, ensuring deliverable quality, and helping to expedite the preparation of regulatory submission. It will also to support statistical analysis during submissions and post-submission regulatory response period by independently developing and/or validating analysis datasets, and TLFs.