- Merck & Co. (Rahway, NJ)
- …applying rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead , Oncology Global ... PDT lead will manage the entire cycle of clinical development , including development strategy, study design, initiation, execution, monitoring, analysis,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Evolution Oversee product strategy and regulatory activities related to new clinical data or label changes. Lead modification to marketing strategies ... products in the pipeline, and products acquired through business development efforts in existing and new areas....within the TA. This role is responsible for guiding product development and commercialization strategies for late… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams. The project teams will be defined based on the project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC ... potential critical issues, or to the governance bodies. Responsibilities - Accountability to lead teams within overall CMC development project(s), to support Sr… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and CDP. Lead (or have subordinates lead ) cross-functional product decisions including approach for tech development , manufacturing network strategy, and ... as developing activity plan, and budget for project. He/she (or subordinates) will lead cross-functional product decision and manage project team by working with… more
- Merck & Co. (Durham, NC)
- …providing equipment troubleshooting, calibration, and maintenance support for a new product feasibility project/manufacturing support. Develops standard ... Job DescriptionLead Technician, Maintenance (O4) Lead Maintenance Technician will be a leader with...problems that cross into inter-related unitsAssisting in the identification, development , and implementation of new systems which… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Strategic Application product roadmaps to meet business goals and objectives. Lead the definition of solutions based on business needs, cost, and required ... legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a...produce preliminary solution design and architectural diagrams. 35 E- Lead technical feasibility discussions, prototype development , and… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop ... (SDPC, our Manufacturing Division ) in the design of new formulations and development of robust and...record of publications in parenteral drug product development and/or deliveryDemonstrated ability to lead cross-functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …preparation of Kessai and/or Project Entrustment documentation for budget approvals. The Lead will also manage vendor relationships, Product Vendors and ... world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory and clinical processes, preferably within diabetes Proven track record in new product planning or marketing Solid understanding of the pharmaceutical ... products in the pipeline, and products acquired through business development efforts in existing and new areas....our future. The Position The Ecosystem & Enterprise Influence Lead is responsible for driving strategic initiatives to address… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... consistent with CDP and aligned to achieve the Target Product Profile (TPP) Development of clinical sections of...tables, listings, and figures (TLF) and CSR safety narrativesMay lead the development and updates of the… more
- Insmed Incorporated (San Diego, CA)
- …potency assay cell line engineering, development and banking.Participates as an Analytical Lead on Product Development Teams and Global Asset Teams as ... biology techniques.Write and review protocols, SOPs, reports and other product development documentsConceptualize, construct, validate, and implement screening… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Regulatory Lead for asset to reach resolution.Participate in global product team meetings to provide US regulatory support and guidance as needed and ... legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a...effective regulatory strategies to deliver on efficient and robust development plans. The individual will direct, coordinate and implement… more
- Insmed Incorporated (San Diego, CA)
- …Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead clinical programs ... delivering high quality clinical programs, from first-in-human trials, through to full development .Serve as the therapeutic area lead of the ophthalmology… more
- Merck & Co. (Rahway, NJ)
- …within the organization.Primary Responsibilities:Responsibilities: Lead development of new , innovative approaches for product development , generation ... scaling-up the formulation, device, and manufacturing process.- Driving drug product design from the bench top to the Good...processAbility to lead complex teams in the development of new molecules and new… more
- Merck & Co. (Rahway, NJ)
- …Minimum three (3) years of direct people leadership experienceProven track record of CMC development for new product introduction and product life ... and Commercialization Expertise :- Proven experience in small molecule product development , commercialization, and supply, including comprehensive knowledge of… more
- Genmab (Plainsboro, NJ)
- …(s)BLA submissions. Evaluate various regulatory mechanisms that allow optimization of product development (eg, orphan drug designation, breakthrough therapy ... will work in close collaboration with the Global Regulatory 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… more
- Genmab (Plainsboro, NJ)
- …as BLAs/MAAs. Evaluate various regulatory mechanisms that allow optimization of product development (eg, orphan drug designation, breakthrough therapy ... team, and labeling working group meetings, as required for the assigned projects Lead the strategic development of briefing materials and prepare teams for… more
- Merck & Co. (Rahway, NJ)
- …NDA/MAA, agency background packages, post-approval submissions/variations, 510(K)s, CE markings. - Lead the development , communication, and review of Regulatory ... tracking, and communicating regarding submissions and approvals to support continued product supply.Participate - in early and late development programs,… more
- Merck & Co. (Rahway, NJ)
- …compound(s)/ program(s). The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting ... and for supporting all protocol and program cost estimates requested by Product Development Teams.- Responsible for authoring clinical supply documentation in… more
- Merck & Co. (Rahway, NJ)
- …with global scientific leaders and key decision makers. The EDMA partners with Product Development Team leaders and Global Brand leaders. They collaborate with ... & medical affairs plans for Ophthalmology). They build and lead a team of TA dedicated global and regional...through the global Value and Implementation TeamPartners with the Product Development Team, Global Brand and V&I… more
