- 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)
- …and global medical affairs activities. Represent Medical Affairs in new product planning, life cycle management, co-development and co-promotion discussions. Foster ... effectively manage annual operating plan and budget for the Oncology Medical Strategy Group. Support the US Medical Affairs department through participation on the… more
- Merck & Co. (Rahway, NJ)
- …Human Health, our Manufacturing Division and corporate functions including Finance, Strategy and Investor Relations.- GPAM has approximately 250 employees located in ... development and project management within biopharma and other science-based product innovation industries to bring innovation, external perspectives, new ideas,… 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)
- …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)
- …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
- 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 ... Lead(s) on a compound in late-stage development to implement the US regulatory strategy for multiple new indications. You will act as contact person with FDA… 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
- 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)
- …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)
- …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
- Genmab (Plainsboro, NJ)
- …time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy , Global Regulatory Affairs, the key responsibilities include but are not ... and maintenance of US/global regulatory strategies (in line with Target Product Profile). For approved products, ensure that regulatory strategies throughout… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company's Digital Strategy is founded on the need for efficient, reusable, and user-friendly technology solutions. The Enterprise Architecture ... driving use cases such as capability-based planning and roadmapping.Partnering with the product leads, teams, and divisional architects to reuse the best available… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …your potential? The Position Formulates, leads and executes the pricing and contracting strategy for a key Novo Nordisk product category. Collaborates with ... aligned therapeutic / franchise area(s). Relationships Reports to the Executive/Senior Director of Value Communication and Contracting Strategy . Interacts… 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
- 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
- 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
- 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)
- …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
