- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manages multiple biological developmental projects with supervision, including working with contract manufacturing organizations CMO. This position serves as the ... Regulatory Affairs (RA) CMC project representative to the CMC...multiple biological developmental projects with supervision, including working with contract manufacturing organizations CMO. This position develops strategy, prepares… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. ... while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role… more
- Merck & Co. (Rahway, NJ)
- …with late-stage process development, process characterization, process validation regulatory submissions, and working with external contract ... cross-functional teams to foster collaboration and innovation.Document Excellence: Author regulatory and technical documentation, ensuring all processes align with… more
- Genmab (NJ)
- …methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role ... analyses requiring advanced statistical methodologies/techniquesRepresent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or… 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 ... The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be...in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well… 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)
- …analytical investigations with a strong focus on quality and regulatory compliance.Excel in impurity isolation, unknown peak identification, characterization of ... other spectroscopic techniques.Collaborate closely with internal company sites and Contract Manufacturing Organizations (CMOs) within the manufacturing network to:Identify… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …development strategy with a focus on expanding our pre-clinical contract research portfolio and building long-term, high-impact relationships.The Pre-Clinical ... Lead all client-facing efforts, including prospecting, proposals, presentations, and initial contract negotiations. Serve as a primary point of contact for key… more
- Formation Bio (New York, NY)
- …high-value negotiations with vendors across multiple categories, including software, contract research organizations (CROs), contract manufacturing organizations ... and data security requirements. Identify opportunities for cost savings, contract optimizations, and risk mitigation. Implement procurement analytics and reporting… more
- Genmab (NJ)
- …methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role ... requiring advanced statistical methodologies/techniques Represent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or… more
- Genmab (NJ)
- …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 ... of high-quality clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. You will help...in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and communication beginning with customer request and concluding with signed contract Represents National Accounts team in Pre-Pricing Committee and other pricing ... and contracting discussions Continually assesses contract performance and proactively provides input/insights into PCOR and S&I teams Demonstrates a strong… more
- Genmab (NJ)
- …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 ... relevant therapeutic and professional areasMaintains up-to-date knowledge on relevant regulatory guidelines/requirementsMaintains a good working relationship with stakeholders and… 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
- Aequor (Collegeville, PA)
- …what (if any) additional requirements are needed to comply with regulatory requirements and policies. In addition, Business Analysts assign trade classification ... accounts, which drives customer invoice terms, discounts, taxes, eligibility for contract pricing, and may control access to specified products. POSITION… more
- City of Spring Hill Kansas (Spring Hill, KS)
- …independent judgement and simultaneously considering the financial, ethical, legal and regulatory variables that affect the City is vital. Performs complex and ... person regarding industrial, commercial and residential prospects. Assists with contract development, development agreements, property sales or acquisition and… more
- Aequor (Swiftwater, MN)
- …on assays. Develop a working knowledge of appropriate compendia and/or regulatory guidance. Attend/contribute to scheduled team meetings, department, and safety ... setup, usage, and maintenance Sample preparation and disposal Coordination of contract laboratory testing * Chemical handling required with appropriate PPE provided.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Enterprise Insights, Supply Chain, Procurement, Public Affairs, Public Policy, Regulatory , Legal, IT, Trade, Patient Safety and Compliance. External relationships ... appropriate customer-facing channels Manage relationships with key vendors and lead contract negotiation and renewal process Partners with vendors and oversees the… more
- Merck & Co. (Durham, NC)
- …Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing development and ... (21 CFR Part 4, Medical Device Reporting, ISO 13485:2016, EU Medical Device Regulation, etc.). Strategic Sourcing and Contract Negotiation-Requisition ID:P-100912 more
