- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & ... Process Lead actively engages with leadership across the Global Regulatory Affairs and Clinical Safety organization and collaborates with internal and external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Merck & Co. (Lower Gwynedd, PA)
- …activities and all other associated Quality functionsUnderstands and applies regulatory / compliance requirements relative to their role.Experience working within ... Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late Development (AdVAnce)...pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …programs, and overseeing the management of speaker and HCP program operations and technology systems. This position will also lead the development of operational ... new Market Development and HCP Engagement processes to meet changing regulatory requirements, and establish appropriate compliance training and communications… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 ... areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and… more
- Merck & Co. (Rahway, NJ)
- … regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development & ... Technology . The incumbent must be able to work well...integration of the device development activities with the clinical, regulatory , formulation, commercial and other key Ofunctions. Lead … more
- Merck & Co. (North Wales, PA)
- …activities, second generation process development including process characterization, technology transfer to internal and external manufacturing sites, manufacturing ... investigations, process validation, and authoring of regulatory submissions. - - Under the general scientific and administrative direction of Director in the CCFS… more
- Merck & Co. (South San Francisco, CA)
- …in translational cell models, mechanistic pharmacology, and biomarker and lead discovery to join our Quantitative Biosciences (Pharmacology) department. The ... experimentation to advance early drug discovery projects from target concept through lead optimization. The candidate will work closely with a team of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Principal Scientist of Device Technology Assessment and Early Development will spearhead early-stage device technology evaluation ... and assessment of emerging drug delivery device technologies. The ideal candidate will lead efforts in assessing the viability of new concepts and drive early… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT)… more
- Merck & Co. (North Wales, PA)
- …stakeholders, such as regulatory authorities, health care professionals, and patients.- Lead PV projects: Partnering with the business technology partner, ... for Product Manager - PV Case Intake and Processing. Reporting into Product Line Lead Patient Safety and Quality & Compliance , this position will be responsible… more
- Merck & Co. (Durham, NC)
- …Manager will be responsible for activities that support cGMP and regulatory compliance during facility design, construction, start-up method transfer/validation ... for the company; uses this knowledge in own workUnderstands and applies regulatory / compliance requirements relative to their roleInfluence, motivate, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 ... rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... drive new ideas, but also have pragmatic approach to development options, technology selection and regulatory postureDemonstrated ability to identify, mitigate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality ... of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise...the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from… more
- Merck & Co. (Rahway, NJ)
- …activities, second generation process development including process characterization, technology transfer to internal and external manufacturing sites, manufacturing ... investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction of Director in the CCFS group… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …function is to lead and/or support complex filing activities, ensuring compliance with technical and regulatory standards. This role involves efficient ... regulatory standards, contributing to the organization's success and regulatory compliance .ResponsibilitiesCoordinate global regulatory dossier generation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …marketing, market access, commercial insights and analytics, sales, medical/CMR, legal, compliance , and regulatory . Other internal relationships include Public ... contractual arrangements, SOPs, KPIs, and budget. Ensure adherence to all compliance and regulatory requirements Fiscal management: Demonstrate fiscal discipline… more
- Merck & Co. (Rahway, NJ)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We ... we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.-The Distinguished… more
