- Daiichi Sankyo, Inc. (Bernards, NJ)
- …growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA ... meetings.Serve as the primary contact with FDA and liaise, negotiate and orchestrate meetings and teleconferences with FDALead and prepare FDA submissions, including but not limited to briefing documents, breakthrough therapy designation requests, orphan drug… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and plan for FDA meetings ... for assigned product. Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting minutes to capture the full discussion for archiving. Serve as the primary contact with FDA.Lead and prepare FDA submissions, including but not limited to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director , New Products Portfolio Strategy , is a critical role to continue to transition our company and ramp up new oncology assets. The ... Director leads or supports various strategic and operational initiatives. This role reports directly to the Vice President, Oncology New Products.Key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 requiredAdvanced degree (eg, Masters, Pharm.D., Ph.D., MD, JD) preferred Experience Qualifications7 or More Years in the pharmaceutical industry4 or More Years in regulatory affairs, NDA, sNDA, BLA filing to FDA Travel Ability… more
- Merck & Co. (Rahway, NJ)
- …the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy , lead activities, and develop a ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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. ... ResponsibilitiesProject Responsibilities: Independently manage or lead strategy development on Global Project Teams (GPT) for drug development projects in any phase… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global ... decisions where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong organization and interpersonal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... the effective strategy , design, execution, and interpretation of Oncology clinical trials....medical history, and medications when needed Clinical Development Expertise Strategy :In collaboration with the Global Clinical Lead (GCL), if… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …lead in the ADC/Bio#2. He/she is responsible for developing/proposing integrated CMC product strategy based on a cross functionally designed strategy , as well as ... Project lead.ResponsibilitiesDevelop/propose (or have subordinates) integrated CMC product level strategy (manufacturing site selection for internal vs. external manufacturing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy : Provides the strategic direction to Biostats Data Mgmt & ... Reviews patient population and protocol compliance for consistency with study strategy ; Develops biomarker strategy in collaboration with Translational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborates closely with data manager to ensure high quality data.Drug Development Strategy : Provides input to multiple aspects of the development plan to ensure ... May participate in meeting or teleconferences with Health AuthoritiesGlobal BDO Strategy to Improve Drug Development: Primarily participates and may occasionally… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CMC Lead of an early-stage project. He/she has responsibility for the overall strategy and status of the project with respect to budget, timeline, achievement of ... holders, and SMEs to build and execute an effective CMC development strategy .- Leads special project(s)/committee(s) that are critical to Compound development and/or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group ... group within the company as needed.Responsibilities:Manages, directs, and drives the strategy for all Regulatory activities associated with the registration and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in Corp. Functions so that they and Global DX develop a shared vision, strategy , and roadmap together from the beginning of discussion, and incorporate them into DX ... Global DX to ensure that technology solutions are aligned with the overall strategy and objectives of both the business and Global DXNeeds alignment between business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe Associate Director , Global Business Process Manager, Global DX is responsible for leading ... cross-functional BPM lead functions to implement and influence BPM strategy , including conducting process discovery workshops.Qualifications: Successful candidates will… more
- Merck & Co. (Rahway, NJ)
- …network to enable process and formulation development.- In this position the SMAR&D Director will set guidance, lead activities, and develop a team whose roles ... partnering with CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the...innovative ways to achieve results.Nature and Scope of Position:The Director reports to the Executive Director of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborates closely with data manager to ensure high quality data.- Drug Development Strategy : Provides input to multiple aspects of the development plan to ensure ... participate in meeting or teleconferences with Health Authorities- Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …supports oversight and management of integrations solution design, implementation strategy and requirements gathering, and technical feasibility and delivery. The ... the highest possible business value, while subscribing to the enterprise IT strategy . Additionally, this role collaborates with technical and business leaders to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member ... team of GLLs to ensure alignment of labeling content and strategy and to optimize resourcesDepartment Coordination: Builds cross-functional and cross-regional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assessments to ensure documentation is available for audits and inspections Management Strategy and Goals:Assist in developing PV goals, continued compliance, and ... strategy for process improvement initiatives as a member of PV Operations leadership. Qualifications: Successful candidates will be able to meet the qualifications… more
