Administrative Salary in Basking Ridge, NJ

Join a Legacy of Innovation 110 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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.SummaryOversees one or more trials of medium to high complexity in design and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and regulatory strategy; Drafts protocol profiles and sections of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead.Responsibilities:Medical Monitoring Planning (MD Only): For large Phase 2 or Phase 3 studies: Reviews, edits, approves and updates medical monitoring plan, Develops SAE flow plan for AESI in conjunction w/ CSPV, Defines medical monitoring oversight component of study QOP, Sets up DSMB and/or adjudication committee; reviews and edits DSMB/ Adjudication charters, Develops medical content for protocol profile, protocol and amendments for small, uncomplicated clinical studies; Directs CRO medical monitor activities for Phase 2 studies; Regional sponsor medical monitor for Phase 3 study.Medical Surveillance (MD only): For large Phase 2 or Phase 3 studies: Collaborates with CSPV to ensure monitoring / reporting of AEs/SAEs, Reviews safety reports/data during study conduct, Provides and documents oversight of medical monitoring activities, Reviews data before DBL from medical perspective, assist BDO in creation of TFG, Reviews, oversees creation of patient narratives, Provides medical direction to MW for the CSR; Leads indication specific surveillance and safety summaries, such as Section 2.7.3 of eCTD.Study Strategy: Clinical Study Leader (CSL) or Major Scientific/Medical Contributor; For large or complex Phase 2 Studies: Provides the strategic direction to BDO for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for consistency with study strategy, develops biomarker strategy in collaboration with TMCP, collaborates with external KOLs to refine study plans; Prepares and participate in regulatory agency meetings, if applicable.Study Planning and Execution: As CSL for Phase 2 Studies: Provides input on major milestones of trial, clinical trial plan and contingency planning, Analyzes, updates management on potential risks to study deliverables, provides input on ICF creation, oversees recruitment, retention; establishes and implement contingency plans for shortfalls, Consults recruits members for DSMB and/or adjudication committee setup; Interacts with KOLs and PIs to plan study and monitor completion.Study Outputs: For Phase 2 Studies: Drafts responses to IRBs and HA, Collaborates with TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead e.g. review TLG before DBL, and quality check of data, Works with BDO to ensure SAP updates; Responsible for valid clinical interpretation of study results as Clinical Study Leader, medical monitor or regional clinical/Translational Medicine and Clinical Pharmacology representative.External Collaboration: Develops and leads external advisory panels to advise on Phase 2 study strategy, design, and conduct; Interacts with KOLs for indication specific advice; Leads broad collaboration with KOLs or major institution, e.g., NCI.Scientific, Program Related: Integrated Study Team (IST) Representative: Creates early development plan and contributes to overall development Strategy; Develops program biomarker strategy; Achieves endorsement for plan by function and team; Interprets and react accordingly to new preclinical/clinical e.g., Go/No Go decisions, reprioritization, etc.); Operational Project Team (OPT) leader; Responsible before the IST for the creation and execution of development strategy for a program.People Management: Direct reports management - Hire and retain high quality (Team) members; Ensure team members have updated development plans and provide them with necessary means to achieve their personal development goals; Review annual goals with team members; Prepare annual performance reviews for direct reports and provide them with feedback.Additional Non-Study Related Activities: Initiates contact w/KOL and prepare material for KOL interactions on a program-based need; Peripheral involvement in Business Development activities for late-stage compounds Involvement with in-licensing and acquisitions on individual due diligence activities; Contributor to portfolio decisions.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)MD or equivalent requiredPostgraduate training in TA or related specialty preferred Experience Qualifications4 or More Years relevant clinical experience required.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.

Join a Legacy of Innovation 110 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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.SummaryThis position is responsible to support strategic leadership of QA initiatives within QA and will have the primary responsibility to collaborate with, and support the head of Global QA strategy and operations. In this position, the incumbent will take on organizational responsibilities relevant to drafting global communications for QA, QA projects as assigned, ensuring onboarding of N-3 leaders directly reporting to the VP of Quality, and in close collaboration with the QA Training and Documentation management team. This position will take direction from global strategy and operational QA leader, however is also accountable to the VP of quality. The incumbent is expected to understand and apply rigor, focus and dedication with respect to the complexity of the Global organization. This position has considerable latitude to make decisions without supervisor approval and solves problems while carrying out assigned duties. Additionally, this position is responsible for upholding a strong commitment to confidentiality and routinely handles sensitive documents that may impact multiple Global organizational units or Global project teams. The incumbent may be tasked under the direction of the Global Strategy and Operations Head, to draft presentation for VP of QA, assess organizational transformation and its effectiveness and support large conferences and meetings. The incumbent must have excellent communication, oral and written skills. The incumbent must have understanding of state of the art technology systems necessary to complete tasks and allow decision making.Responsibilities- Support Head, Global strategy and operations on projects needing to be coordinated with both DSI QA and Global QA, ensure that teams are adequately engaged to deliver as expected and escalate any delays to Head of Group and / or Head Global strategy and operations.- Supports Head Global Strategy and Operations for Global RD/PV/MA QA relevant activities including QQR, monthly quality report, team building and management review.- Involve and attend the Global QA relevant meeting and create the draft of presentation, meeting agenda and meeting minutes.- Involve and attend the Global RD/PV/MA QA strategic meeting and create the draft of presentation, meeting agenda and meeting minutes.- May be delegated for logistic planning and coordinating the QA Meeting which including the QA leadership meeting, Global QA meeting etc.- Support Head, Global Strategy and Operations to track the objective and the mid-term plan in Global QA to ensure Global QA activities globally.- Support Head, Global Strategy and Operations to draft the Global RD/PV/MA QA strategy operation plan with Head, Global QA function to ensure Global QA activities globally.Support Operational activities:- Manage the QA shared point and ensure that information provided is accurate and reflects on going activities. Regularly check the site for accuracy, up to date information, and links as well as compile new content as required. Send periodic alerts to teams to ensure that shared point data is current and accurate- In collaboration with Head, Global QA Strategy and Operations, Collate and produce accurate and timely reports as needed pertaining to Global QA activities- In collaboration with Executive admin, ensure QA org charts, team lists, projects assigned to individuals are current and up to date- Support regulatory inspection related activities as required- Support Head, Global strategy and operations to develop and plan the Global QA governance, communication strategies and manage the communication activities;- Distribute reports as necessary to the Global QA teams and ensure on time organization communication is cascaded to the teams for awareness.- Creates and proofs packets of information; develops documents and materials for meetings and a wide array of audiences- Edits and produces advanced internal and external communications; acts on behalf of an executive for certain decisions or activities (e.g., e-mails)- Create the weekly QA communication e-mail- Administrative support includes but not limited to: Responsible for travel, Financial Administration as needed (e.g. tracking of expenses for travel and office space), meeting arrangements for Head of Group and other associates as applicable. Handling of confidential documents (reorganization, talent profile, Financial Budget)- Manage Calendar for DSI QA Head and Head, Global Strategy and Operations and ensure an organized approach- Onboarding support: Coordinate QA on boarding business training with New Hire and ensure New Hire has a sufficient access to the system and information to do that work.- Review the QA onboarding business slides edits and updates as neededQualifications: 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 scientific discipline or higher in, health care, or related discipline; and/or background in Medical Health Profession requiredHigher level of education preferred such as:- Master's Degree in scientific discipline or higher in, health care, or related discipline; and/or background in Medical Health Profession preferred- PharmD in scientific discipline or higher in, health care, or related discipline; and/or background in Medical Health Profession preferred- PhD in scientific discipline or higher in, health care, or related discipline; and/or background in Medical Health Profession preferredExperience Qualifications- 7+ years of professional pharmaceutical experience in project management and operational support role and relevant additional career training or equivalent experience required- Must have broad understanding of Health Authority expectations in the areas of Pharma Development; preferably working in a GxP regulated environment, pharmaceutical industry.- Proven knowledge of training and curricula development experience desirable, including oversight and administration of validated electronic systems such as LMS or other quality management systems.- Must possess strong interpersonal, communication, negotiation and problem-solving skills.- Organizational awareness (e.g. inter-relationships of departments, business priorities), including experience working cross-functionally, Cross cultural and in global teams- In depth knowledge and working experience with common computer software programs, i.e. MS Office Suite (Word, Excel, Access, Outlook, PowerPoint, Visio, MS Project)Physical Requirements: Shipping out large packages/boxes. Moving/arranging file folders in large quantities. 5% of TimeTravelAbility to travel up to 5%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.

Join a Legacy of Innovation 110 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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.SummaryThe Director of Metrics and Benchmarking is responsible for cultivating a culture of Measurement Centricity within R&D to ensure continuous improvement in ways of working, leveraging both quantitative and qualitative means. Define and implement a model to measure Key Performance Indicators, Key Quality Indicators, Key Risk Indicators and other targeted operational metrics across each R&D Line Function. Establish internal and external benchmarks to inform future planning and target setting. Oversee Annual Target Setting Process as part of Yearly Functional Objectives. Establish commentary collection process for outliers to drive intervention, escalation and continuous learning. Oversee the build and governance of a Metrics Library and Database with clear definitions and thresholds along with mappings to processes and roles. Oversee the development of Dashboards tailored to various reporting audiences, functions and processes to improve decision making. Responsible for managing external Benchmarking Study Submissions and seeking out external competitive intelligence to provide line of sight to outside environment. Advise on and track Measures of Success for all Non-Drug Projects relating to System and Process change. Educate Line Functional Associates and Leadership on the value, use and definition of all metrics. Extract insights and communicate key messages through executive summaries and supporting decks. Oversee the selection and monitoring of metrics for Resource Mgmt, Risk Mgmt and RBQM. Oversee the production of the Project 4D R&D Dashboard in partnership with DX. Evolve existing Dashboard Approach/Content e.g. SEOC into more impactful suite of Dashboards with clear purpose and maximum utilization/effect. Advise and Partner closely with Data Governance in order to implement proper standards and data quality measures to ensure Metrics are of the highest level of accuracy. Support the development of a cross-system standard, adhoc and self-service reporting environment allowing Line Function users to customize and refresh reports as needed. Develop a seamless partnership with other roles in Global R&D Excellence in particular the Business Engagement Leads to maintain a pulse on in-function needs and adoption. Direct/Indirect Line Management of Data Analysts/Data Scientists who will produce the metrics, reports and outputs. Responsibilities- Metrics, Benchmarking Competitive Intelligence Define, Build and Govern Metrics, KPIs, KRIs, KQIs across all RD LFs Drive Annual Target Setting Process through Senior Level Engagement Alignment Track RD and Functional Progress against agreed objectives Build and Maintain Metrics Catalog along with strategy for End User Education Develop and execute plan for Capture, Categorize and Report on Qualitative Commentary/RCA/Learnings Prepare Executive Summaries and present on insights/learnings Develop Harmonized model for Measure of Success definition for Non-Drug Project (IT/Non-IT) along with tracking of realized benefits Develop and Govern measures to assess 3rd Party Performance- External Benchmarking Competitive Intelligence Leverage public source data to evaluate competitive landscape and insert intel into internal decision making processes Submit required data for External Benchmarking Surveys, distill insights and Socialize Outputs Maintain relationships with 3rd parties and Peer companies to gain additional perspective on changing industry trends, challenges and performance measures/standards Seek opportunities to secure new external data drive partnership with vendors in this space- Reporting Provide oversight and direction around the build of a standard and adhoc reporting environment, moving away from single system vendor developed reports into a cross-system integrated internal reports Provide oversight and direction around the build of a self-service reporting capability to allow end users to update and modify reports on-the-fly without support Define, Develop and Govern the production of a series of Dashboards tailored towards various roles and levels within RD along with defined process flows for optimal use- Collaboration/Partnership Partner with Functional Leaders/SMEs to ensure alignment on Metric targets, usage, insights and outputs Partner closely with other key roles in Global RD Excellence to ensure optimal build and adoption of metrics Work with other Non-RD functions (DX/IT, CSPV, QA, DX, Legal, Commercial, Med Affairs, Drug Supply) to leverage additional targeted data for RD purposes along with identifying shared metrics of valueQualifications: 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 Computer Science, Life Science, Engineering, Business Administration or a related discipline or equivalent work experience is required- Master's Degree preferredExperience Qualifications- Minimum 9 years experience in the pharmaceutical industry in Clinical Drug Development supporting multiple functional stakeholder groups globally, working with internal and external data from Research through to Development to develop Performance Metrics required.- Minimum 3 years leading a Metrics group, responsible for the definitions and governance of KPIs, KRIs and KQIs, reporting out from associate to leadership levels preferred.- Experience within or supporting Clinical Drug Development processes, roles, data and systems is required required- Demonstrated ability to influence at all organizational levels through clear, concise, and impactful verbal and written communication skills. required- Experience analyzing, extracting and communicating insights along with driving tangible improvements in metric outcomes required- Experience establishing yearly metric targets and overseeing the production of Dashboard Outputs required- Knowledge of Industry Metrics Standards such as the Metrics Champion Consortium required- Experience managing Benchmarking study submissions working with vendors such as CMR/KMR requiredDaiichi 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.

Join a Legacy of Innovation 110 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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.SummaryThis position is responsible for the quarterly global consolidation, supporting both external reporting and internal management financial reporting for a collaboration program. This position has responsibilities of working closely with various functions within the company and acting as a liaison with the external partner for a smooth consolidation process. Also responsible for managing various studies including late stage budget and forecasting, analysis, strategic planning, internal reporting, and ad hoc reporting and analysis.Responsibilities- Project Planning and Forecasting - Manage and is accountable for the development of Clinical Project Budget templates in support of early phase to late stage clinical studies. Accountable for the control and reporting of GEMRAD approved budgets. On a monthly basis prepare actuals vs. budget spending reports and communicate to relevant team members. Proactively investigate the reasons for any deviations from forecasted spending and provide guidance to the internal project team(s) during the annual and quarterly forecast updates. Manages and is accountable for developing and building strategic planning and forecasting models in support of the organization's Mid-Term Plan (MTP) process.- Consolidation of Reports - Accountable for the ownership of the multi-functional consolidation process and preparation of financial packages to senior management and to external party for the collaboration program. Participate in the review and analysis of quarterly financial results against plan and monitor key changes between current forecasts vs. prior forecast or year over year during each reforecast and budget cycle and present key findings to alliance partner.- Business Partnering - Develops effective working relationships with business partners and influences strategic decisions to align to company objectives. Develops strong business knowledge of the Functions to help find synergies efficiencies across the organization. Challenges the status quo in an appropriate way to find more optimal and cost-effective approaches that are aligned to our strategy.- Building Financial Models - Develop and continue to refine a financial model for all phases of clinical trials. Research and investigate key parameters through quantitative analyses of historical data and assist in designing initiatives and development of analytical capabilities and dashboards needed for short- and long-term planning cycle to satisfy growing demands for faster and more complex analysis required to support company's making decisions.- Analytics - Develops and prepare detailed analysis of variances, risks opportunities, trending analysis along with KPI's. Effectively uses and communicates key findings and presents recommendations to senior management.Special Projects/Change Management - Create and maintain up-to-date process documentation for all tasks; recommend and implement process improvements, as appropriate, to simplify, standardize and streamline efforts.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 Finance/Accounting concentration preferred areas of study or other relevant discipline requiredExperience Qualifications- 4 or More Years Business environment required- 4 or More Years Finance/Accounting experience required- 1 or More Years Support of R&D organization preferredTravelAbility to travel up to 10%. Travel required for accounting conferences/trainings, Global Finance meetings and Project team support.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.

Innova Solutions is immediately hiring for a Project Manager - Cloud/AI/ML Position type: Contract Duration: 12+ Months Location: Basking Ridge, NJ/ Ashburn VA,/Irving, TX, Boston, MA (Hybrid) Description: As a Project Manager - Cloud/AI/ML you will :- Be the AI&Data lead supporting the Network enablement organization's clients. Be the central coordination point across all AI&Data development partners. Help drive requirements definition, scope / impact assessment and delivery execution. Influence and partner with business and technology stakeholders across the organization to build consensus, develop a technology solution and implementation timeline. Facilitate the intake, organization, and prioritization of projects and Use Cases Drive the development and application of new technologies focused on AI and Big Data Lead cross-functional initiatives, develop action plans, establish milestones, and provide status updates Manage and communicate key timelines and deliverables to execute on strategic initiatives Stand up Ad-hoc Work Groups (AWGs) and Proofs of Concepts for new Big Data AI initiatives Lead requirements session, Core team grooming, Scope and impact assessment, Story point estimation, and sprint planning, if applicable Develop and communicate project schedules. Define and coordinate resources needed from across AI&D to enable effective execution of goals Analyse and manage project risk. Develop risk mitigation plan Define and manage development roadmap in line with strategic vision. Clear communication up and down the organization on project status. Identify opportunities to accelerate value capture within the Transformation program. Develop action plans, secure owners, and identify mechanisms to validate value capture. Support annual and multi-year capital planning and strategy. Communicate effectively verbally, visually and quantitatively. MUST HAVE SKILLS (Most Important): Bachelor's Degree in Engineering, Computer Science or other Technical Discipline 5+ years in a Technical Project Management role Demonstrated experience leading medium to large scale complex technology projects. Agile, SAFe, Scrum Familiar with Network Cellular Technologies Comprehensive understanding of how field organizations operate, a plus DESIRED SKILLS: AI / ML experience preferred Excellent verbal and written communication skills. Strong product development capabilities in an enterprise or cross-functional role Delivery capability in technology Familiarity with project management tools (e.g. Jira, Rally, Clarity, Quickbase, Smartsheets) The ideal candidate will have: Project Management, AI / ML, Agile, SAFe, Scrum and Network Cellular Technologies. Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW. Thank you! Nikita Awasthi PAY RANGE AND BENEFITS: Pay Range*: OR $75 per hour> *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). ABOUT INNOVA SOLUTIONS:Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centres across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields. Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022) ClearlyRated® Client Diamond Award Winner (2020) One of the Largest Certified MBE Companies in the NMSDC Network (2022) Advanced Tier Services partner with AWS and Gold with MS Website: https://www.innovasolutions.com/ Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected] or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.

Join a Legacy of Innovation 110 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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.SummaryThe Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for assigned projects and activities to achieve regulatory milestones and deliverables successfully and in a timely manner. The manager, RPM contributes to the RPM group by sharing best practice and escalating process and operational issues in a timely manner and continuous RPM process improvement with focus on quality, reliability, consistency and efficiency.ResponsibilitiesPlan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (e.g. Protocol Amendments, Form 1572s, Information Amendments, Meeting Requests/Background Materials, DSUR, IND/NDA/BLA annual reports, BTD request etc.)Develop less complex Module 1 regulatory documents (e.g. cover letter, FDA forms, administrative information, letter of authorization, etc.) for US regulatory submissionsSupport GRL with scheduling regulatory meetings, preparing agenda and tracking action itemsResponsible for maintaining global health authority query (HAQ) tracker and archiving regulatory correspondencesSupport DSUR/PBRER preparation by attending Kick-off Meeting, coordinating and assisting in developing regulatory sectionsSchedule RRT meeting, creates response templates and coordinates processes for authoring and review of response as appropriateProvide support or coordinate other regulatory activities per direction from GRL and regulatory strategistsShare RPM best practices and contributed to RPM process improvementKeep current with regulatory and scientific regulations, guidelines and initiativesQualifications: 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. Preferably in a scientific disciplineAdvance degree (e.g. MS, PharmD, Ph.D) preferredWork Experience4 or more years of overall related experience (education and/or industry) is preferred1 or more years of industry experience within regulatory is preferredOrganized and detailed orientedExcellent oral and written communication skillsAbility to collaborate effectively with key stakeholdersAbility to plan, coordinate and lead activitiesDaiichi 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.

Join a Legacy of Innovation 110 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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.SummaryProvide strategic leadership for all statistical programming activity related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global harmonization of programming processes supporting global submission.Responsibilities- Statistical Programming Management: Coordinates outsourced statistical programming of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth knowledge of regulatory authority's requirements.Typically has administrative responsibility for recruiting, retaining, developing, and managing employees. Guide career growth and provide development opportunity for statistical programmers. Manages contract statistical programming staff to ensure proper resource allocation for achieving successful project deliverables. Provides oversight of all statistical programming activities performed by contractors in different oncology trials as well as submission-related activities, e.g., integrated summary of safety (ISS) and integrated summary of efficacy (ISE).- Direct Project Support: Providing direct support to key studies in order to ensure sufficient planning of statistical deliverables from vendors as well as work by in-house statistical programmers.- CRO / Vendor Oversight: Manages higher-level negotiations and provides oversight of budget, resources, and timelines for contract research organizations (CROs) for multiple projects and ensures timely delivery of high quality deliverables at reasonable cost. Identify/develop tools for efficient vendor management.- Global Health Authority Interaction / Negotiation: Reviews documents and responses submitted to health authorities globally with respect to data standards, compliance, etc. May represents the function at health authority meetings. Reviews and provides input to TLF shells for submission documents (e.g., ISE and ISS). Develops the process for ensuring that analysis data sets and outputs are compliant with regulatory requirements, including CDISC ADaM data set specifications, reviewer's guides, etc.- Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation of vision and strategy, and identifies technology needs for the function to improve the harmonization and efficiency which leads to cost savings and accelerated worldwide product submissions and approvals. Authors or initiates writing of global standard operating procedures for statistical programming practice, especially with respect to oversight of vendor performance. Oversees compliance with standard procedures and processes. Leads the development and refinement of analysis data standards for AML as well as solid tumor studies.- Leadership of Strategic Initiative and Cross-Functional Collaboration: Provide leadership for strategic and process improvement initiatives within Biostatistics Data Management. Works with colleagues at DST and DSE to identify opportunities for global harmonization and process improvement. Ensure close collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs, etc.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 an accredited institution in a science or in a technical field preferred- Master's Degree preferredExperience Qualifications- 10 or More Years experience (Bachelor 12 or More Years) in pharmaceutical industry preferred- Thorough understanding and proficiency of CDISC. preferred- Advanced knowledge of CDISC requirements for SDTM and ADaM. preferred- Worked and played major role in electronic NDA and/or BLA submission via eCTD preferred- Working knowledge in statistics as measured by ability to interpret SAPs/shells to generate ADaM and TLFs. preferred- Strong project management experience and ability to manage and execute multiple projects and deadlines preferredDaiichi 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.

Join a Legacy of Innovation 110 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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.SummaryThe Senior Director, Global Oncology Medical Affairs is responsible for developing the Global Medical Affairs (GMA) strategy and tactical plan as part of the Global Brand Strategic Plan and leads the execution of the activities in the GMA plan including Launch Readiness and Life Cycle Management for the assigned compound and will report into the Global Oncology Medical Affairs Franchise Head.Responsibilities- Responsible for the development of the Global Medical Affairs strategy and medical objectives for the assigned compound or therapeutic area and leads development, execution of the Global Medical Affairs plan and budget management including activities related to evidence generation, scientific engagement and communication as part of Launch Readiness activities and life cycle management from a medical perspective- Serves as Global Medical Affairs Team (GMAT) Lead, to gain strategic and planning alignment across the matrix team consisting of regional medical affairs and core GMA functions. Represents medical affairs function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team, and Global Product Team to inform clinical development, commercialization, market access, and other cross-functional strategic discussions. Lead the team with sleeves rolled up, model the way and enable the team to act.Provides medical leadership to- GMA clinical operations teams as part of evidence generation forums and study teams for Local/Regional Medical Affairs company sponsored study concepts as needed. Partners with RWE strategy and Biomarker/CDx leads on related integrated evidence generation strategies and activities as part of the GMA Plan. Provides medical review of expanded access programs (EAP) and, investigator-initiated studies (IIS) as part of a Global IIS Review Committee, for assigned compound.- Collaborates across GMA functions to develop, review, and align on key scientific communications and medical information response documents within legal and compliance regulations. Leads internal stakeholder medical education activities related to the compound data. In partnership with Medical Intelligence and Congress Planning leads, communicates and educates on related competitor data.- Provides medical leadership in scientific engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key thought leaders. Provides medical support for scientific symposium and medical congresses within legal and compliance regulations.- Works with Patient Advocacy leads and Grants office to incorporate the patient voice and define external medical education strategies for independent grants, respectively.- Provides input into publication strategy, data gap analysis, and tactical planning as part of the overall GMA plan. Reviews and approves abstracts, manuscripts, and other data disclosure documents.- Manage budgets and resources efficiently for GMA supported activities within the GMA plan, in collaboration with GMA Franchise HeadQualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)An advanced doctorate degree (PharmD, PhD, MD, DO or equivalent) in medical/ scientific area is required. Experience in oncology therapeutic area is requiredExperience Qualifications- 10 or More Years Pharmaceutical industry experience or commensurate healthcare or research experience required- Minimum of 5 years of (in-house) medical affairs or related experience, global required- Must have oncology experience, specifically in solid tumors required- Previous overall responsibility and accountability for multiple indications of one or more compounds and related GMA plan/budget for related MA activities required- Demonstrated ability to lead and influence others internally and externally •Experience leading matrix medical teams (e.g. GMAT) and representing medical on cross-functional leadership teams (e.g. Global Product Team, Global Brand Team, etc.) •Relationships with key external experts required- Proven ability to manage multiple priorities at one time required- Knowledge of ADC or other biologics, or small molecules preferred- Demonstrated experience working with an alliance partner company preferred- Experience in hemato-oncology preferredTravelAbility to travel 20-25%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.

Join a Legacy of Innovation 110 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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.SummaryPosition supports safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant medical topics, and supports PV Operations' medical review function. This position supports a senior physician in evaluating and mitigating safety signals as they arise. Additionally, this position works with other CSPV staff and cross functional Safety Management Team (SMT) members, often handling straight-forward CSPV tasks such as single event level AE causality assessment. This position requires manager review and gains industry knowledge through multiple opportunities.ResponsibilitiesSafety Expert - Overall: Develops safety knowledge working closely with CSPV management.Safety Expert - Signal Identification: Carries out routine signal identification activities formulated by manager. Uses medical knowledge to aid the SMT's signal identification efforts.Safety Expert - Signal Evaluation: Assists manager in assessing new signals.Safety Expert - Risk Mitigation & Communication: Communicates any safety concerns to management and relevant team members.Reports and Submissions: May contribute to writing minor safety sections of the NDA, CSR, and IB. May review any safety submissions for medical accuracy.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)MD with board eligibility requiredExperience Qualifications1 or More Years of clinical experience preferredDaiichi 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.

Product ManagerLocation: Basking Ridge, NJ (Expectation is every Tuesday & Wednesday in office)Duration: 12 MonthsTechnical Product Manager services to be performed:• Experience within retail, digital or wireless industries highly desired.• Translate strategic priorities into a product roadmap and detailed product specifications.• Collaborate with engineering and data teams to define implementation plans, prioritize work items, triage issues, and run scrum meetings.• Work across the business, engineering, and product orgs to execute WMG roadmap.• Develop metrics to monitor and quantify the impact of new products to be launched.• Coach, lead, or complete efforts in capturing customer needs, structuring projects; defining user journeys and user stories, business and technical requirements, and new product features.• Work with Engineers to translate needs into technical requirements, manage resources and resolve issues.• Apply and establish controls to deliver cross-functional projects, across the project lifecycle, at scale.• Make decisions and recommendations backed by data, evidence, and pragmatic judgment.• Partner closely with product development teams to understand their needs and goals.• Drive the process of introducing, breaking down, and delivering epics with internal and external vendor development teams.• Lead conversations with stakeholders and gather feedback on delivered solutions.• Drive early adoption of new functionality with product development teams.