- Merck & Co. (Rahway, NJ)
- …the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead ... and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior position responsible for effectively planning, ... wide range of functions in Daiichi Sankyo (DS). Reporting to the Sr. Director , Enterprise Program Management, this position requires a capable leader with strong… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …success of product messaging, programs and promotional effort. The Associate Director is also responsible for a broad array of brand functions including ... research areas centered around rare diseases and immune disorders. SummaryThe Associate Director , Consumer Marketing serves as the patient, brand and product … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Senior Director sits within Global Oncology Clinical Development , an organization dedicated ... are consistent with CDP and aligned to achieve the Target Product Profile (TPP) Development of clinical sections of trial-level regulatory documents (eg, response… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development , an organization ... consistent with CDP and aligned to achieve the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg, response… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …based on customer insights, external landscape, and internal information including overall product development plans.- Proactive planning for asset milestones to ... plus emerging pipeline assets to advance our research and development . This role will lead workstreams with highly matrixed...critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead and core… more
- Aequor (New Brunswick, NJ)
- …as with business partners such as IT. This role will report to the Sr Director , Product Development Strategy. Responsibilities Collect and curate data from ... Brunswick, Local Candidates Only please Work Schedule: Mon - Fri, Business Hours Product Development (PD) at is committed to accelerating CMC development to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Planning, Clinical and Safety sub-teams, US and Global Brand Team, and US Product Team to inform clinical development , commercialization, market access, and ... for assigned compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US Oncology Medical Affairs (USOMA). Develops… 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...Pharmacovigilance (CSPV) for assigned products. This position drives/leads the development and maintenance of the CCDS, US and EU… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …plan, budget and CDP. Lead (or have subordinates lead) cross-functional product decisions including approach for tech development , manufacturing network ... in a global company).10+ years of expertise in project management, process, product , and/or analytical development activities and oncology project development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …4 or More Years Extensive experience in project management, process, product , and/or analytical development activities and pharmaceutical/oncology project ... defined based on the project needs and the respective development stage of the project. The CMC Lead will...transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Job Summary Deliver the development and implementation of informatics systems and programs to support the ... global sites. These business functions include: Clinical Operations, Clinical Development , Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to ... under some supervision to solve complex study problems. Responsibilities Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP),… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leads statistical support for medium complexity studies including contributing to development of optimal study design, independently develop and execute statistical ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary Deliver the development and implementation of Research & Development (R&D) informatics systems ... global sites. These business functions include: Clinical Operations, Clinical Development , Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …breakthrough therapy designation requests, orphan drug applications.Participate in global product team meetings ( development and marketed products); provide ... implement effective regulatory strategies to deliver on efficient and robust development plans. The individual will direct, coordinate and implement the preparation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry, vendor base, and regulatory issues for respective categories. Leads the development of sourcing strategy for respective categories. Builds and maintains a ... vendor base. Manages vendor relationships. Implement sourcing and value development roadmap and initiatives; contribute to strong supplier relationship management,… 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 ... including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety...may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …high quality compound and multi-compound level deliverables. Lead the development of global harmonization of programming processes supporting global ... developing, and managing employees. Guide career growth and provide development opportunity for statistical programmers. Manages contract statistical programming… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team (GPT) for these plans, ensuring appropriateness throughout the product 's lifecycle and across different indications.Represent Global Regulatory Affairs on ... regional interdependencies, program regulatory risks, and opportunities in the development of global regulatory strategy and plans, considering therapeutic area… more
