- 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)
- …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)
- …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)
- …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)
- …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)
- …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)
- …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
- 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
- IQVIA (Bridgewater, NJ)
- …enablement teams to drive client transition strategy . + Able to drive the product strategy for individual modules within our overall solution set. + Able to ... The ideal candidate will be responsible for developing the strategy and vision for IQVA's next generation of core...the customer" and translating that into short and long-term product roadmaps with relevant revenue projections and business cases… more
- Bayer (Whippany, NJ)
- …the highest impact for our customers; + Execute national level programs to advance Product strategy across the Customer Engagement squads (ie, National POAs); + ... make a real difference, there's only one choice.** **Senior Director Field Operations Strategy , Oncology** Bayer Pharmaceuticals...Oncology, are to: + Shape the national Field Operations strategy for a Product Squad, including driving… more
- Sanofi Group (Bridgewater, NJ)
- **Job Title:** Director of Brand Content Lifecycle Strategy **Location:** Bridgewater, NJ **About the Job** The Established Products team within the General ... with business objectives, brand consistency, and compliance with regulatory requirements. The Director works closely with content strategy , regulatory and legal… more
- J&J Family of Companies (Raritan, NJ)
- Johnson & Johnson is currently seeking a Senior Director , Regulatory Affairs Global Strategy Implementation to join our team preferably located in Raritan, NJ, ... reach their potential. At Johnson & Johnson, we all belong. The Senior Director , Regulatory Affairs Global Strategy Implementation partners with MedTech Surgery… more
- Sanofi Group (Bridgewater, NJ)
- **Position Title: - Director , Portfolio Marketing Strategy Lead - Portfolio Marketing** Location: Bridgewater and Morristown + 50% remote working and 10% of ... immunize over half a billion people worldwide per year. The Head of Portfolio Strategy will report to the Portfolio Marketing and Operations Head, and will work in… more
- Merck (West Point, PA)
- …Our company is seeking a highly motivated candidate for the position of Director , Vaccine Drug Product Development. Vaccine Drug Product Development ... with VDPD leadership and extended leadership teams to implement strategy , direct phase appropriate research & development from the...The Director will report to the Executive Director of Vaccine Drug Product Development, have… more
