- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as the CMC working group leader of GPT. He/she will supervise the PJ Lead ADC/Bio#2 member and is the accountable for the ADC/Bio#2 and an integral member of the ... holder is responsible for the provision of CMC project lead in the ADC/Bio#2. He/she is responsible for developing/proposing...interface with R&D unit as the CMC working group leader of GPT and ensure alignment across the two… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and ... the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead ...time zones required Daiichi Sankyo, Inc. is an equal opportunity/ affirmative action employer. Qualified applicants will receive consideration for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary The Non-Regulated Implementation Services Lead is responsible for the strategic oversight, planning, and execution of ... services are developed, implemented, tested, and integrated efficiently and effectively. The Lead will define and drive the methodology, approach, and best practices… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …products. When goals are tactically misaligned or at risk for these assets, this leader will be responsible for bringing the issue and potential solutions to the ... matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to US, EU and Japan. 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. more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development plan. This position is accountable for partnering with the Global Team leader as the Project Management lead on drug development projects. This ... supporting divisional and departmental level objectives and may also lead a non-project initiative in support of these objectives....This position will report to the Sr Director, Group Leader , GPM&L or the Executive Director, US Head GPM&L.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and maintains a working relationship with the internal project team(s) and team leader (s) or US based Global Function leaders as a Finance Business Partner.Provides ... are always maintained and accurate.Accountable to the Global Team Lead (GTL) and GPT (Global Project Team) for the...timely management decisions.This position will work with the team leader to understand the needs of senior management, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …has both leadership and management responsibilities and is considered a global leader for a therapeutic area or a large program in CSPV ... stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from ... of new and updated Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of GLLs, manage, develop prepare and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …communication, and GBD team training & development efforts. This experienced leader will ensure communications with key stakeholders are strategic, engaging, ... shows, newsletters, annual impact report, organizational announcements, etc..)- Training and Development: Lead the development and roll out of a broader training and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on major milestones of ... regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality check… more
- Lundbeck (Minneapolis, MN)
- …NE and the state of Minnesota. SUMMARY:Are you a results-driven biopharmaceutical sales leader looking to be part of an organization that values being a curious, ... goals for promotedproducts within our psychiatry portfolio. Set and lead the development of area strategic direction and tactical...to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory strategy is endorsed by GPT and other governance bodies.Serve as a leader of the GRT (Global Regulatory Team)The primary point of contact with Alliance ... Qualifications:4 or More Years of proven experience in a regional regulatory lead role7 or More Years of relevant pharmaceutical experience including 5 years… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are responsible for the delivery ... cross-functional meetings or other relevant activities.Support the External Partner Quality Lead (s) (EPQLs), who are responsible for delivering and executing Quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from ... of new and updated Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of GLLs, manage, develop prepare and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …HCM Platforms and processes. This position will act as the functional lead with technical and operational expertise across multiple HRMS applications, possessing ... and maintenance of the Company's global HRIS system (ie, SAP SuccessFactors). Lead respective workstream(s) to gather, document, implement and validate all system… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the company's Compliance Department and will report to the US Sustainability leader and will 1) manage the US Environmental Social Governance (ESG) Sustainability ... e-learning and other educational programs to promote sustainability initiatives.- Assist leader in serving as liaison to Sustainability Department in Tokyo and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the ... (CSR). May review tables, listings, and figures (TLF) and CSR safety narrativesMay lead the development and updates of the Investigator's Brochure (IB): author the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary The purpose of this job is to lead certain pipeline support activities and assist in the identification, coordination assessment, ... proposal/review/negotiation of EOI/NBTS and Definitive Agreements, either acting as Lead for simple opportunities or supporting more complex transactions. Work… more
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