- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & Clinical ... across regions and functional areas. The role of the Global Process Lead involves developing and maintaining efficient, effective, and compliant business … more
- Merck & Co. (Rahway, NJ)
- …of diseases in people and animals. In the capacity of a Global Labeling Lead , you will be instrumental in shaping the labeling strategy and ensuring the development ... you to demonstrate your superior execution skills.Core ResponsibilitiesAs a Global Labeling Lead , you will guide cross-functional teams in the creation, review, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure that deliverables are met according to agreed timelines and quality standards . Lead a team of professionals specializing in intelligent automation, ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Merck & Co. (Rahway, NJ)
- …state-of-the-art technology and applying rigorous scientific and ethical standards .-The Distinguished Scientist (Executive Director) and Product Development Team ... (PDT) Lead , Oncology Global Clinical Development, has primary responsibility for...field of m elanoma . The Executive Director, PDT Lead will manage the entire cycle of clinical development,… more
- Merck & Co. (Rahway, NJ)
- …Associate Director brings forward strong subject matter expertise to lead studies and evaluations, determine suitability, establish direction, conduct risk ... and industry guidance are preferred.- Candidate should have demonstrated ability to lead a cross functional team through design and execution, while championing… more
- Merck & Co. (Rahway, NJ)
- …seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in supporting the pharm and vaccine veterinary ... enhance the efficiency of our clinical research operations.Key Responsibilities:- Lead Data Management Initiatives:-Direct the development and maintenance of… more
- Merck & Co. (Rahway, NJ)
- …and Plant) within RIPL. -As Sr. OT Infrastructure Specialist, you will lead the definition and implementation of high-level requirements, principles and models that ... for GMP manufacturing processes, secure networks compliant with ISA/IEC 62443 standards .Be the SME for our Shop Floor Network (Manufacturing division Core… more
- Merck & Co. (Rahway, NJ)
- …the individual to be an independent contributor as well as be a lead partner in helping to scope, design, and deliver well-defined advanced analytics solutions ... aligned to the HHDDA top programs (ie, PIE CON).- The ideal candidate will lead a cross functional insights team that spans data science, market research, data… more
- Merck & Co. (Rahway, NJ)
- …and assessment of emerging drug delivery device technologies. The ideal candidate will lead efforts in assessing the viability of new concepts and drive early ... intellectual property (IP) considerations in collaboration with the Legal department. Lead early feasibility/development studies to determine viability and inform on… more
- Merck & Co. (Rahway, NJ)
- …health and wellness.Responsibilities include, but are not limited to, the following: Lead a team of scientists to conduct validations, technical transfers, and ... analytical results to meet project milestones and regulatory requirements.Sets high standards , builds, and develops a high performing team.Collaborates with the… more
- Merck & Co. (Rahway, NJ)
- …the Company's consolidated financial statements in accordance with US GAAP standards . This pivotal position involves coordinating, preparing, and analyzing the ... Accounting, this role is integral to our financial management team.Key Responsibilities: Lead the monthly financial close process by preparing and reviewing… more
- Merck & Co. (Rahway, NJ)
- …execution of scientific & medical affairs plans for Ophthalmology). They build and lead a team of TA dedicated global and regional directors and associate directors. ... for assigned TAsProvides a solid understanding of how countries' medical systems and standards of care need to change to accept new innovation, how to introduce… more
- Merck & Co. (Rahway, NJ)
- …and colleagues in other related function areas. Primary Activities : Lead programming deliverables for multiple studiesProvide technical consultation and analytical ... project plan including resource forecastingSupport the development of programming standards to enable efficient and high-quality production of programming… more
- Merck & Co. (Rahway, NJ)
- …Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic partnering ... of and hands-on work in applying regulatory guidance and quality standards related to product release and safety.NOTICE FOR INTERNAL APPLICANTSIn accordance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies...the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... 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… more
