- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and global medical affairs activities. Represent Medical Affairs in new product planning, life cycle management, co-development and co-promotion discussions. Foster ... bidirectional communication and alignment between US and Global Medical Affairs.- Oversee the interpretation, publication/ public disclosure and interpretation of scientific data generated by studies conducted by the Oncology teams. Oversee the development of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Project Teams including strategic development and execution of an integrated product development plan. This position is accountable for partnering with the ... these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director...strategy development and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg, ... if applicableDelivers all relevant components needed for maintenance of product licenses (eg, Core Data Sheet generation/revision; clinical benefit-risk assessments… 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 ... Business Partners as required to assure compliance with PV agreements. Participate in audit and inspection readiness activities. Provide input for remediating PV system deficiencies cited in audit/inspections. Implement effective corrective and preventative… 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 ... plan, and budget for project. He/she (or subordinates) will lead cross-functional product decision and manage project team by working with other L-1 functions… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Director , CMO Operation as part of the Global Manufacturing and Supply team ... plan, schedule and track the manufacture of autologous cell product batches at CMOMonitor the progress of product... product batches at CMOMonitor the progress of product batches, identify and escalate deviation and other manufacture… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meet smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to ... or More Years Extensive experience in project management, process, product , and/or analytical development activities and pharmaceutical/oncology project development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position ... may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages multiple assigned projects of increased complexity including post marketing projects and those involving 3rd party development.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …providers to deliver GxP application solutions. Responsible for Strategic Application product roadmaps to meet business goals and objectives. Lead the definition ... with the business users to define user information needs, research innovative product value proposition, and collect ideas for future roadmaps and planned projects;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor Oversight: Review CRO/vendor proposal and ... budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies. Ensures deliverables are accurate and delivered according to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 Safety & Pharmacovigilance (CSPV) for assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 Safety & Pharmacovigilance (CSPV) for assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for regulatory filings.Strategize and plan for FDA meetings for assigned product . Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting ... and/or Global Regulatory Lead for asset to reach resolution.Participate in global product team meetings to provide US regulatory support and guidance as needed… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will also support more complex projects, including those to acquire new product opportunities or technologies to augment our pipeline. This person is responsible ... for coordinating cross-functionally (eg with commercial, R&D, legal, IP, finance, supply chain, and other relevant functional area colleagues), at varying levels, and across geographies. Externally, the job requires initial meetings with potential partners;… 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 therapeutic areas (TA), under the guidance of the Associate Director , GOMA Scientific Engagement.Contribute to the management and execution of activities ... community to enable flow of information from/to medical community. Assists Associate Director , GOMA SE in developing Scientific Engagement strategies for the TA, in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …data (PED) evidence to support optimization of access & reimbursement, clinical practice, product development and registration. The Director serves as a visible ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...you ready to make a difference? The Position The Director , Patient Centered Outcomes Research, is responsible for the… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, ... and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, and… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part of our Global ... submissions. Evaluate various regulatory mechanisms that allow optimization of product development (eg, orphan drug designation, breakthrough therapy designation,… more
