- Daiichi Sankyo, Inc. (Bernards, NJ)
- …SummaryThe Job holder is responsible for the provision of CMC project lead in the ADC/Bio#2. He/she is responsible for developing/proposing integrated CMC product ... plan, and budget for project. He/she (or subordinates) will lead cross-functional product decision and manage project team by...group leader of GPT. He/she will supervise the PJ Lead ADC/Bio#2 member and is the accountable for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and ... needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage project or act as main CMC … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary The Non-Regulated Implementation Services Lead is responsible for the strategic oversight, planning, and execution of ... services are developed, implemented, tested, and integrated efficiently and effectively. The Lead will define and drive the methodology, approach, and best practices… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary The Oncology Early Development Center (OEDC) Program Lead , who directly reports to the Head of the OEDC, supports the OEDC ... innovative, science-driven portfolios with an equally robust and agile infrastructure. The Program Lead plays a central role in supporting OEDC to drive strategy and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing ... or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution.Participate in global product team meetings to provide… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the Quality team based in Raritan, NJ. Role OverviewThe QA Document Control Lead role is an exempt level position with responsibilities for supporting the document ... management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ensure compliance within the document management system, document storage and retention, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Collaborate cross-functionally with stakeholders to align IT projects with business goals, gather input, prioritize initiatives, and develop functional IT roadmaps in ... alignment with Daiichi Sankyo's mid-term goals. Aid in the delivery of a strategic short- and long-term IT transformation plan to business, ensuring continuous improvement and optimal solutions that support business processes as well as unmet business needs.-… more
- Merck & Co. (Rahway, NJ)
- …device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position ... applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …embark on shaping our future. The Position The Rare Bleeding Therapeutic Area Lead is instrumental in shaping and executing NNI's strategic direction and initiatives ... the competitive landscape, market research, historical products, and payer landscape Lead market development and unbranded activities for the TA Market Opportunity… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The HCP - Strategy Lead (MASH) lead will be a pivotal driver in shaping an insights-driven HCP ... and message. Relationships Reports to the Integrated TA Strategy Lead . Responsible for providing interface with key internal and...objectives, KOL engagements, and strategies. The HCP - Strategy Lead (MASH) has a team of HCP and KOL… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and HCP program operations and technology systems. This position will also lead the development of operational business plans to meet evolving regulations and ... recruitment process, relationship management, training activities, and management metrics Lead development of commercial readiness strategy and oversees execution of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of safety profile of assigned molecules/products and ... stakeholders. Relationships This position will report to Senior Global Safety Lead /Director/Senior Director - Safety Surveillance, US East Coast Development Hub. Key… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Brand Strategy Lead is pivotal in developing brand level objectives and strategic priorities. They will ... area objectives. Relationships Reports to the Integrated TA Strategy Lead . Collaborates closely with cross-functional teams, including sales, marketing, medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on shaping our future. The Position The Ecosystem & Enterprise Influence Lead is responsible for driving strategic initiatives to address the complex challenges ... distrust, and disparities in healthcare service. Collaborating with internal teams, the Lead will assess the current landscape, develop strategic plans, and drive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are responsible for the delivery ... cross-functional meetings or other relevant activities.Support the External Partner Quality Lead (s) (EPQLs), who are responsible for delivering and executing Quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …visits (expectations of staff contact, ISF review, IP review, SDV/SDR, etc.)Establish and lead the Sponsor Oversight Visit process. Provide oversight of the DS Trip ... site training material as stated in the CSOPSupport and/or lead mitigation of CRO/vendor oversight findings. Additional Collaboration Opportunities:Support strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from ... Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of...new products or products in the development phase. Independently lead cross functional teams through all labeling discussions with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and risk ... and leadership. Provide coaching, motivate, direct, and foster teamwork, lead cross-functional, multi-cultural teams to develop talents among CSPV organization.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the ... (CSR). May review tables, listings, and figures (TLF) and CSR safety narrativesMay lead the development and updates of the Investigator's Brochure (IB): author the… more
