- Merck & Co. (Rahway, NJ)
- …for management of third party manufactures of our Company's products across drug substance, drug product and packaging operations.- The organization helps ... resolution with appropriate escalationBalancing our company's delivery requirements with contract manufacturer's production plan. Materials Management (ERP transactions, Logistics)Oversight… more
- Genmab (NJ)
- … drug development pertaining to statisticsExperience with the relevant regulatory requirements for biostatistics processes and SOPsExperience with regulatory ... scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation… more
- Merck & Co. (Rahway, NJ)
- …through leadership and collaboration.Maintain a deep understanding of the regional regulatory and business environment, including:API and Drug Product ... broad deliverables including, but not limited to, API and Drug Product analytical problem-solving and optimization, trace impurity quantitation, characterization… more
- Aequor (East Syracuse, NY)
- Job Title: Scientist, Analytical Sciences & Technology Contract : 12 Months Location: East Syracuse, NY Job ID: 1167 Qualifications Education / Experience / Licenses ... used in the testing and characterization of raw materials, excipients, in-process, drug substance, and drug product samples including HPLC/UPLC methods and… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading ... portfolio of products. The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be within Global … more
- Formation Bio (New York, NY)
- …multiple categories, including software, contract research organizations (CROs), contract manufacturing organizations (CMOs), and other drug development ... is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …obligations deriving from these contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:Contribute to the ... language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of… more
- Merck & Co. (Rahway, NJ)
- …with late-stage process development, process characterization, process validation regulatory submissions, and working with external contract ... Our Team as an Associate Principal Scientist/Associate Director in Biologics Drug Substance Commercialization!Are you ready to make a significant impact in… more
- Genmab (NJ)
- …scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation ... and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role modelEnsures consistency of statistical methods and… more
- Genmab (NJ)
- …you join us!The RoleAre you ready to make a meaningful impact in oncology drug development and be part of a dynamic, collaborative team that values innovation, ... Manager to help us tell the story of our science through compelling clinical and regulatory documents. You'll be at the heart of a team that plays a critical role… more
- Tris Pharma (Monmouth Junction, NJ)
- …to develop and implement procurement strategies and operations, contract negotiations, supplier relationship management, procurement systems functionality/workflows ... and assurance of compliance with GxP and other company and regulatory agency procurement policies and procedures throughout the organization. Ensures compliance with… more
- Genmab (NJ)
- …are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety, Medical, Clinical Pharmacology and Biomarker functions with the above ... other analyses not pre-defined in the SAP), answers to questions posed by regulatory authorities or ethics committees, answers to in-house questions related to data… more
- Insmed Incorporated (San Diego, CA)
- …including interpretation of results and reporting that stands up to regulatory inspection.Demonstrated expert knowledge of scale-up principles with respect to viral ... and procedures suitable for inclusion in IND, NDA, or equivalent regulatory submissions.Must be familiar with BSL-II lab safety requirements.Participate in… more
- Merck & Co. (Durham, NC)
- …seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate ... Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing development and… more
- Sanofi Group (Cambridge, MA)
- ** Regulatory Affairs Innovation Lead - VIE Contract ** + _Location: USA, Cambridge_ + _Target start date:_ _01/12/2025_ iMove, the Sanofi VIE Program, is ... **About the job** _As_ **_Regulatory Affairs Innovation Lead VIE_** _within our Global Regulatory Operations team, you'll be at the forefront of transforming how we… more
- SRP (Coolidge, AZ)
- Contract Procurement Analyst 1, 2, Senior Location: Coolidge, AZ, US Date: Jul 18, 2025 **Requisition ID** : 19045 **Join us in building a better future for ... corporate strategies for purchases of major equipment/materials/services and for contract development associated with critical materials and services and to… more
- Parker Hannifin Corporation (Hauppauge, NY)
- …principles, industry practices, regulations, and policies. Knowledge of legal and regulatory requirements related to contract administration, and government ... Contract Administrator Senior Location : HAUPPAUGE, NY, United...to ensure company data and intellectual property meets all regulatory requirements. + Recommends actions by analyzing and interpreting… more
- Parker Hannifin Corporation (Miami, FL)
- …industry practices, regulations, and policies. Knowledge of complex legal and regulatory requirements related to contract administration and government ... Contract Manager / Leader Location : Miami, FL,...subject expert and internal consultant on overall contracting processes, regulatory requirements, negotiation techniques, and evaluation of risk. Provides… more
- Defense Logistics Agency (Whitehall, OH)
- Summary See below for important information regarding this job. Responsibilities As a Contract Specialist you will be responsible for one or more of the following ... analysis, and/or award. Determines the appropriate type of acquisition strategy and contract for new purchase requests. Performs a full range of post-award duties… more
- Parker Hannifin Corporation (Naples, FL)
- …principles, industry practices, regulations, and policies. Knowledge of legal and regulatory requirements related to contract administration, export control, ... Contract Adm Location : NAPLES, FL, United States...to respond to significant inquires or complaints from customers, regulatory agencies, or members of the business community. +… more
