- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy , lead activities, and develop a ... and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, and… 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …AEs, medical history, and medications when needed Clinical Development Expertise Strategy :In collaboration with the Global Clinical Lead (GCL), if applicable, leads ... protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quarterly Reports) in paper and electronic format.Participate in global product team meetings (development and marketed products); provide regulatory support ... and guidance and manage day-to-day regulatory activities.Collaborate with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings.Mentor/instruct and provide guidance to direct reports.Review and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and delivery of the clinical development plan in alignment with the product development strategy .Manages the team meetings including developing the agendas ... Global Project Teams including strategic development and execution of an integrated product development plan. This position is accountable for partnering with the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and divestments. Negotiate and organize transfer of PV Business in case of Product Divestment Collaborate with DSI audit groups to ensure comprehensive auditing of ... assessments to ensure documentation is available for audits and inspections Management Strategy and Goals:Assist in developing PV goals, continued compliance, and … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project lead in the ADC/Bio#2. He/she is responsible for developing/proposing integrated CMC product strategy based on a cross functionally designed strategy ... in the Project lead.ResponsibilitiesDevelop/propose (or have subordinates) integrated CMC product level strategy (manufacturing site selection for internal… 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 ... meet smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to… 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 ... sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review CRO/vendor proposal and budget.… 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 ... projects, and process automation initiatives. BPM Knowledge Development and Product Enhancement:- Enhance stakeholders' BPM knowledge through training, coaching, and… more
- Merck & Co. (Rahway, NJ)
- …to inform access strategy and evidence generation plans.Develop global pricing strategy , product value scenarios and negotiation strategies in support of ... Job DescriptionTitle: Director , Global Market Access, Cardiovascular;Our company has an...and implementation of integrated access strategies, excellence in pricing strategy and execution, and shaping of the external access… 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)
- …collaborates closely with data manager to ensure high quality data.- Drug Development Strategy : Provides input to multiple aspects of the development plan to ensure ... scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor Oversight: Review CRO/vendor proposal and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and 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 and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc ... member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assets for operational matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including ... for regulatory filings.Strategize and plan for FDA meetings for assigned product . Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting… more
- Merck & Co. (Rahway, NJ)
- …As a product owner for PIE, you will be responsible for defining the strategy , vision and roadmap of the product . You are an ideal candidate for the ... Job Description Director of Customer Knowledge Capability & Patient Insights...a successful product experience.- Key job responsibilities: Product vision and strategy : Defining the overall… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a visionary Executive Director to lead our End-to-End Technical Leader organization and join the leadership team of Small Molecule ... organization is responsible for three core areas within SM S&T: (1) technical product leadership across the lifecycle of product franchises, (2) project and… more
- Merck & Co. (Rahway, NJ)
- …. - Responsibilities include but are not limited to: Working independently through product development teams to devise a patenting strategy with the goal ... continued R&D and drive access to life-saving medicines for patients? If so, the Director , Biologics Patent Attorney role , at our Company could be an ideal… 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 ... methods to characterize and release clinical drug substance and product and their stability tests, raw materials/excipients, and packaging components… more
