- Merck & Co. (North Wales, PA)
- …/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical ... protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and… more
- Merck & Co. (Rahway, NJ)
- …( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ... and external to GCS and serve s as the lead GCS spokesperson at clinical and development.... - Familiarity with Good Manufacturing Practices (GMP) requirements, quality procedures, and Standard Operating Procedure (SOP) execution. -… more
- Merck & Co. (Rahway, NJ)
- …/scientific execution of clinical protocol(s) . This may include: Serving as the lead clinical scientist on the clinical trial team. Leading medical ... protocol in collaboration with Data Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality , or cell therapy.GxP Quality ... the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the...Preventive Actions (CAPA) process and is responsible for ensuring compliance within quality systems processes.Key Responsibilities Provide… more
- Eisai, Inc (Nutley, NJ)
- …the execution of all aspects of end-to-end clinical trials with the utmost compliance and quality consistent with Good Clinical Practice (GCP). This ... ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical...Clinical Operations staff to oversee all aspects of clinical trial development. Lead clinical study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Eisai, Inc (Nutley, NJ)
- …start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support, creates, and communicates clinical ... your profile, we want to hear from you. The Clinical Trial Assistant will support all phases of ...reviews, reconciliation and study file archivalPerforms detailed eTMF CRO quality check reviews with follow-up for missing documentation under… more
- Merck & Co. (Rahway, NJ)
- …Engineering). The role is on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical ... (PSCS)The FLEx sterile facility supports the formulation and filling of clinical and developmental supplies for sterile products, including critical program needs… more
- Merck & Co. (Rahway, NJ)
- …solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non- clinical , Clinical , and other ... Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and… more
- Merck & Co. (Rahway, NJ)
- …operations staff, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ... Data-Driven Decision Making, Drug Product Development, Estimation and Planning, GMP Compliance , Management Process, Manufacturing Quality Control, Medical Supply… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for overseeing the production of a personalized cell therapy to support both clinical and commercial requirements in either a Grade C or sterile cGMP environment.Key ... and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile… more
- Merck & Co. (Durham, NC)
- …routine internal and external GMP and Financial audits, QSAT actions, to ensure compliance .- This is a fast-paced and multi-faceted role that provides leadership and ... external GMP and Financial audits, input to QSAT actions, to ensure compliance .Support the Master Data team with general Material Handling Steward tasksDrive safety,… more
- Merck & Co. (San Francisco, CA)
- …Skills:Budget Development, Business, Clinical Supply Chain Management, Clinical Trial Management, Compliance Frameworks, Cross-Cultural Awareness, Decision ... DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) organization, the Digital Project Manager will streamline… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Aequor (Thousand Oaks, CA)
- …Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network and with various agency submissions while delivering NPI ... Manufacturing" role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems,...vital to the impact that ATO B20 with a clinical and commercial product mix has to the network.… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Eisai, Inc (Indianapolis, IN)
- …(S-suite, C-suite, KOLs, Pathway and PandT committee members). Each ABL will lead account responsibility for a defined number of potential strategic accounts and ... of representatives selling efforts in accordance with strategic plans and compliance , monitoring and driving sales goals, and coaching Sales Representatives on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …focused on an EHS first mindset, a Right First Time culture of quality , permanent inspection readiness compliance mindset and passionately drives continuous ... internal audits of the facilityPartner and manage relationships with contractors to ensure quality of work and compliance with all company policies and… more
- Merck & Co. (Rahway, NJ)
- …as Outcomes Research.Under the guidance of a senior leader, this individual will lead a team of outcomes research professionals to develop value evidence strategies ... agencies, and health systems globally. The ability to successfully participate in and lead cross-functional teams is a critical part of this role. The Executive… more
- Merck & Co. (Rahway, NJ)
- …multi-product launch manufacturing.To achieve this, this highly experienced leader will lead cross-functional launch readiness teams at each site, drive the ... teams, partner functions including Global Science Engineering and Commercialization (GSEC), Quality , and CMC Regulatory Affairs, as well as, the GBO Leadership… more
