- Legend Biotech USA, Inc. (Raritan, NJ)
- …in written, oral, or diagram.Ability to deal with complexity across the drug product, the associated manufacturing process, and the end-to-end supply chain ... salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.Legend Biotech maintains a drug -free workplace. more
- Genmab (NJ)
- …three years of demonstrated success in oncology sales.Gynecologic Oncology, Antibody- Drug Conjugate (ADC) therapy, and solid tumor experience preferred.Oncology ... resulting in a proprietary pipeline including bispecific T-cell engagers, antibody- drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced… more
- Insmed Incorporated (NJ)
- …a broad understanding of pharmaceutical development!Expert knowledge of all phases of drug development, of the functions and processes relevant to drug ... development, and project management principles applicable to the biopharmaceutical environment!Extensive experience in planning and execution of investigational materials supply strategiesPay Range:$171,000.00-239,667.00 AnnualLife at InsmedAt Insmed, you'll… more
- Insmed Incorporated (NJ)
- …R or other statistical software packages Significant knowledge of the drug development process, clinical trial methodology, and relevant regulatory requirements for ... drug approval Significant experience in global regulatory submissions Extensive knowledge of and experience with CDISC standards including SDTM and ADaM dataset… more
- Insmed Incorporated (NJ)
- …stagesStrong submission writing and review skills essentialExperience with orphan drug products is highly preferredExperience with inhalation products a ... FDA, EMA, and other global regulatory agenciesDeep understanding of the drug development processHighly organized with strong attention to detail, accuracy, clarity,… more
- ValSource, Inc. (Worcester, MA)
- …technically skilled leaders in Process/Process Equipment Engineering to support exciting GMP Drug Substance and Drug Product capital projects throughout our ... network and specifically in our Northeast Region (Greater Boston area). This is a key part of strengthening ValSource's role in front-end Engineering and enabling end-to-end support for our clients. ResponsibilitiesWe are seeking passionate, energetic leaders… more
- Merck & Co. (North Wales, PA)
- …data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects.Be accountable for submission data ... a clinical trial environment. Requirements: Experience in US and/or worldwide drug or vaccine regulatory application submission including the development of… more
- Insmed Incorporated (NJ)
- …You'll Do: Responsibilities:Support supplier selection sourcing projects in areas such as drug substance, drug product, clinical services, and packaging services ... within a contract manufacturing structureAbility to build relationships and earn trust of incumbent and prospective suppliersConfidence to communicate and present in group settingFinancial skills to analyze pricing scenarios and cost breakdownsOrganize and… more
- Tris Pharma (Monmouth Junction, NJ)
- …the organization. Ensures compliance with all current GxPs, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and Occupational ... Health and Safety Administration (OSHA) regulations, as well as all applicable company compliance guidelines, standards and objectives Leads and/or oversees functions (ie, purchasing/procurement, warehousing, logistics, etc.) to ensure day to day management… more
- Merck & Co. (Rahway, NJ)
- …(eg temperature monitors).- To provide SME guidance in support of small molecule drug substance and drug product container closure systems including mold ... qualification and regulatory compliance.- To act as master data stewards and support enterprise wide component specification management as well as maintaining documentation systems for the packaging community. The COE teams provide support to life cycle… more
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