- Merck & Co. (Millsboro, DE)
- …is a Biotechnology Center of Excellence that performs vaccine production operations from antigen production through formulation, filling and packaging. With ... position is responsible for overseeing late-shift activities to support the Sterile operations and Logistics Integrated Process Team (IPT) up to and including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global ... Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible... Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations , Clinical Development, RA CMC) to keep processes, procedural… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Summary:The Payments Manager will help lead the strategic direction, operational quality, and innovation of the credit union's payments ... critical role in driving member satisfaction, improving efficiencies, and ensuring regulatory compliance while advancing the credit union's payments strategy in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe Director of Operations is an exempt level position...have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and… more
- Merck & Co. (North Wales, PA)
- …study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment ... engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Merck & Co. (North Wales, PA)
- …specific partners and/or vendors.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing ... IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Adaptability, Adaptability, Clinical Data, Clinical Operations , Clinical Research, Clinical Study Design, Clinical Testing, Clinical… more
- Merck & Co. (North Wales, PA)
- …with partners, vendors, and vendor management team . Review and provide clinical operations input into relevant clinical documents such as the protocol and other ... engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing… more
- BioAgilytix (San Diego, CA)
- …you enable life-changing, life-saving therapeutics to the patients who need them.The Manager II will lead scientific and operational activities in support of ... and aligning employee goals with company strategy by understanding trends and operations , managing departmental budgets and resources, and being the expert in using… more
- Merck & Co. (Durham, NC)
- …is seeking a dynamic and versatile leader for External Manufacturing Operations , Drug Delivery Systems and Devices within our Manufacturing Division (Associate ... Director).-This role serves as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our relationship with External Partners that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related to US Talent Acquisition. Ensures utilized solutions are compliant with regulatory requirement and advises on the same. Ensures Talent Acquisition functions ... for improving Talent Acquisition processes so they are aligned with legal and regulatory guidelines. Ensure that the integrity of US regulations and laws are upheld… more
- Merck & Co. (Rahway, NJ)
- …relationships and effective communications with all stakeholders in all manufacturing operations , analytical testing, quality assurance, regulatory , etc. at all ... Description Job Description The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval of… more
- Merck & Co. (Rahway, NJ)
- …(e . g . , ICF documents/ amendments); Partners with the Study Manager on study deliverables. Ensuring CRF design supports data collection in alignment with ... mentorship to other clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and ICH) Ability to manage… more
- Aequor (Thousand Oaks, CA)
- …site and to directly support both manufacturing and Quality Control operations . Under minimal supervision analyze environmental monitoring samples, cross check ... align with safety guidelines from EHSS, cGMPs, and other applicable regulatory requirements. Adhere to good documentation practices. Complete all required training… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …entire Market Access & Public Affairs Team, PCOR (Pricing, Contracting, Operations and Reimbursement), HEOR, Marketing, Commercial Sales, Medical Affairs, and Legal ... NNI, a self-starter who is self-led and keeps their manager up to date on progress and ensures no...and downstream impact of the evolving public policy, government, regulatory landscape and other relevant trends Identifies and builds… more
- Merck & Co. (Durham, NC)
- …maintenance departments with some oversight to support tactical (day-to-day) operations .Contributes to the performance and results of the department(s).Adapts ... guided by policies, procedures and business plan; receives limited guidance from manager .Prepares routine PMs for execution and ensures materials, tools and permits… more
- Twist BioScience (South San Francisco, CA)
- …QC methods in the production laboratory. He/she will work closely with the operations team to monitor the quality of Twist DNA products utilizing quantitative ... stored, and distributed are manufactured in compliance with all Regulatory , Customer, and Twist requirements. In this position you...In this position you will report to the QC manager .What You'll Be Doing Review and release products based… more
- Eisai, Inc (Nutley, NJ)
- …speakers and related aspects of speaker programsCollaborate with Promotional Program Manager for speaker usage and issuesOffer feedback on nominating new speakers ... of brand plansStrong communication and presentation skillsUnderstanding of legal and regulatory issues impacting pharmaceutical product marketing as well as the… more
