- Genscript USA Inc. (Piscataway, NJ)
- …programs for site staff, contractors, and project teams. Support permit applications and regulatory reporting . Lead site inspections, audits, and emergency ... and background. This position is based fully onsite in Piscataway, NJ. Responsibilities: Lead and manage all EHS compliance activities and initiatives for the site.… more
- Merck & Co. (Rahway, NJ)
- …supply. - A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a ... frictionless flow of data from source systems to regulatory documentation .-- - Under the guidance of dCMC...Management & Communication : The analyst will organize and lead information gathering sessions with the internal CMC community,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Investigation Lead is an exempt level position reporting to the QA Investigation Supervisor ... within the Raritan Investigation Excellence Team. The QA Investigations Lead is responsible for providing quality oversight and guidance during the investigation of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Category Sourcing Lead as part of the Global Operations team based in Raritan, NJ. Role ... innovation, pioneering work and evolving best practices.The Global Sourcing Category Lead is responsible for leading global sourcing activities for direct materials… more
- Merck & Co. (Upper Gwynedd, PA)
- …business questions for GCTOManaging project timelines to enable accurate reporting and functionality during SDLCManaging diverse projects and processes within ... on business requirements for new or enhancement needs to support GCTO reporting .Build relationship with IT, Platform, and operational teams to develop long term… more
- buyer (New York, NY)
- …relationships with its members and providers.Position OverviewThe Medicare Care Manager Team Lead manages day to day activities of the Care Management (CM) team ... implementation of continuous quality improvement strategies. The Medicare Care Manager Team Lead provides training, ongoing support, and mentorship to the CM team.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director, Medical Affairs QA, the Director of Medical ... Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering s culture of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timelines.Develop quality systems and procedures for the signaling activities to assure regulatory compliance and meet regulatory reporting timelines. ... regulatory authorities. Provides compliance metrics to management, as needed. Lead continuous improvement around development of new signal workflow/process,… more
- Aequor (South San Francisco, CA)
- …Support tagging strategy to power personalization, AI/ML classification, and dashboard reporting . Regulatory Support & Audit Readiness Ensure metadata compliance ... and audit readiness. You will work cross-functionally with content strategists, regulatory affairs, product owners, and engineering teams to ensure content is… more
- Insmed Incorporated (San Diego, CA)
- … Regulatory Affairs, and external partners.ResponsibilitiesEDC System Design & Development: Lead the setup, development, and validation of EDC systems, including ... and Best Medium Workplaces™ lists.OverviewThe Associate Director, EDC Programming will lead and oversee EDC programming, and database build for in-house clinical… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operational aspects of clinical study planning, implementation, data delivery and reporting . Will represent DSPD Clinical Operations in a range of cross-functional ... the incumbent may be expected to serve as Program level Delivery Lead on large and/or complex programs, including those involving co-development (Alliance) partners.… more
- Merck & Co. (Rahway, NJ)
- …cell bank and working cell bank) manufacturing operationsStrong understanding of regulatory requirementsAbility to lead without authority, build trust, and ... and biologics commercialization within the expansive Biologics S&T portfolio. Reporting directly to the Biologics Drug Substance Commercialization Leader, you… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition description:- Lead the statistical programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development ... projects.Develop and execute statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of which… more
- Merck & Co. (Boston, MA)
- …medicine leader in our newly created Precision Medicine and Diagnostics function. Reporting to the Associate Vice President ,Precision Medicine and Diagnostics, in ... this role, you will serve as the translational lead on late-stage immunology programs, driving the Precision Medicine objectives in alignment with clinical… more
- Tris Pharma (Monmouth Junction, NJ)
- …Reports (CCRs), methods, specifications, protocols and reports. She/he acts as MV lead for assigned projects regularly reporting status/issues to management, ... (AA), Thin Layer Chromatography (TLC), dissolution apparatus, etc. Acts as MV lead for assigned projects and regularly reports status/issues to managementPrepares MV… more
- Merck & Co. (Durham, NC)
- …in their operational area-Represent Operations on project teams as needed-- Communication- Lead and support daily (Tier) meetings to facilitate flow of information ... the team through actions, coaching, and prioritization-Coach individuals when reporting safety issues and completing corrective/preventative actions-Drive culture of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDirector, Packaging Shipping Systems (Logistics and Distribution Technology) Reporting into the Director Packaging Distribution, Components and Systems ... strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Logistics and Distribution… more
- Soliant (Fort Lauderdale, FL)
- …leadership opportunity overseeing multiple pharmacy managers and staff High visibility role reporting directly to the Chief Pharmacy Officer Lead both operations ... We're seeking aDirector of Pharmacy Operations to lead and oversee the daily operations, compliance, and business growth of a thriving retail/specialty pharmacy near… more
- Merck & Co. (Rahway, NJ)
- …evaluation are required.The Executive Director, Strategic Solutions and Partnerships will lead a team of Business Operations, Innovation, and Key Account Managers ... of the Technology Solutions Leadership team in a direct reporting relationship to the Vice President, Technology Solutions. We...leader in this role - someone who can both lead and do - an ambitious visionary willing to… more
