- Merck & Co. (Rahway, NJ)
- …rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead, Oncology Global Clinical ... Job DescriptionOur Clinical Development teams manage studies to provide the safety...PDT Lead will manage the entire cycle of clinical development , including development strategy, study design, initiation,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Mixed Modalities team within the Sterile Product Development is responsible for developing parenteral dosage forms (injections, implants, ... Chemistry, Biochemistry or related discipline Required Experience and Skills :Deep drug product development expertise with exposure to all stages and aspects of … more
- Merck & Co. (Rahway, NJ)
- …in delivery efficiency and quality.Lifecycle Management and Compliance:Oversee the entire product development lifecycle from conception to deployment, ensuring ... Services' primary responsibilities include, but not limited to :Vision and Strategy Development :Define the product line vision and strategy in collaboration with… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, ... The incumbent will also have to demonstrate domain expertise in sterile product development and collaborate effectively with multiple stakeholders across both… more
- Merck & Co. (Rahway, NJ)
- …division.This challenging position requires deep understanding of new commercial product development and commercialization, proactively identifying risks to ... science with 10 years of industrial experience with pharmaceutical drug substance and/or product development .Ph.D. in chemistry or related science with 7 years… more
- Merck & Co. (Rahway, NJ)
- …of Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our ... planning, risk assessment strategies and will focus on talent development and partnering to build an integrated culture of... of candidates from the discovery interface, through first product registration. They will be responsible for a portfolio… more
- Merck & Co. (Rahway, NJ)
- …years of experience in project management or a related role required - Product development experience required ; in a pharmaceutical/biotech industry preferred - ... Job Description Job Description: - The drug development Project Manager is part of Global Project...Project Manager, is a core member of Early Drug Development and/or Late Drug Development Teams, partnering… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the FDA to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all ... data (PED) evidence to support optimization of access & reimbursement, clinical practice, product development and registration. The Director serves as a visible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP) Development of clinical sections of trial-level regulatory documents ... (eg, DMC, Endpoint Committee, SC, Ad boards).TPP and EPP (Expected Product Profile) development in collaboration with peer functions and CSOversight of Academic… more
- Merck & Co. (Rahway, NJ)
- … and Commercialization Expertise :- Proven experience in small molecule product development , commercialization, and supply, including comprehensive knowledge of ... strategy that aligns with enterprise goals. Ensure the successful transition of drug product candidates from development to commercialization to supply.- Talent … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …direction and initiatives within the TA. This role is responsible for guiding product development and commercialization strategies for late stage and in-line ... Nordisk's Rare Disease portfolio. The mandate of STARS is to facilitate the development and to coordinate the execution of the long-term strategy, defining a… 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)
- … development related meetings (i .e., Clinical Trial Team s ) and product development related meetings . The incumbent must have demonstrated understanding of ... E2E product development process & connectivity between functions supporting pipeline (ie clinical development , CMC, supply chain, & human health), and… more
- Merck & Co. (Rahway, NJ)
- …strong candidate for the position of Principal Scientist (R5) within the Biologics product development group. Primary duties: Be a seasoned biologics product ... supporting regulatory filings. Have deep fundamental knowledge around large molecule drug product development and have management responsibilities for a small… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the FDA to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all ... and effectively managing business risks Creatively advise on the development of product messages and materials across multiple functional areas, and propose… more
- Merck & Co. (Rahway, NJ)
- …Responsibilities:Responsibilities:Lead development of new, innovative approaches for product development , generation of experimental designs, execution ... scaling-up the formulation, device, and manufacturing process.- Driving drug product design from the bench top to the Good...responsible for leading CMC project teams and the formulation development of new chemical entities through a matrix team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the FDA to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all ... make a difference? The Position The Labeling Specialist supports the development of labeling activities for all regulatory submissions. This individual collaborates… more
- Merck & Co. (Rahway, NJ)
- …related to price, value and affordability challenges at the appropriate time of product development and launch. -Partner closely with the cross functional team ... including marketing and Product Development Teams (PDTs), (ex. clinical, CORE and medical affairs), regional and country teams to ensure patient access… more
- Merck & Co. (Rahway, NJ)
- …to be able to lead and problem-solve across a wide variety of project, product , design, development and related topics. A driven, hands-on, and energetic ... Transformation Lead, the successful candidate will have responsibility partner with the product managers and business stakeholders to develop business as well as… more
- Merck & Co. (Rahway, NJ)
- …tracking, and communicating regarding submissions and approvals to support continued product supply.Participate - in early and late development programs, ... with an advanced degree) in pharmaceutical, medical device or combination product research, development and/or manufacturingExperience in CMC regulatory (IND,… more
