- Merck & Co. (Rahway, NJ)
- …ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. ... Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions, Strategic Thinking {+… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Scientist, Device Risk Management Lead , is a crucial member of our team, responsible for spearheading risk management efforts in ... will be responsible for device risk management activities in the following aspects: Lead and contribute to thorough risk assessments for both inline and new… more
- Merck & Co. (Rahway, NJ)
- …development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on programs they lead to ensure high quality ... regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development &… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational quality ... as well as preparing for, management and follow up of regulatory inspections.Operational Quality Management:The Clinical Quality Operations Manager is accountable… more
- Merck & Co. (Rahway, NJ)
- …PAOs to coordinate and cascade expertise. This Leader is innovative, collaborative, strategic , compassionate, and can lead directly and indirectly through ... Job DescriptionRole SummaryThe Director Scientific Patient Engagement Lead is responsible for developing and implementing a global headquarters strategic patient… more
- Merck & Co. (Rahway, NJ)
- …and regulatory requirements. Position Responsibilities Treat data as a strategic asset to empower the organization to drive innovation, make informed decisions, ... gaps versus the ideal state, prioritizing gaps and building execution plans. Lead acquisition of new external assets, formation of partnerships to co-create… more
- Merck & Co. (Rahway, NJ)
- …biostatistical support for related drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical, Regulatory , Statistical Programming, ... in a specific disease area. Primary activities :Serves as statistical representative and lead in the cross-functional teams for the strategic planning and… more
- Merck & Co. (Rahway, NJ)
- …regulatory , company, and customer requirements. - Principal Responsibilities Lead /Support continuous improvement initiatives for design control and risk ... products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance. The role will… more
- Merck & Co. (Rahway, NJ)
- …Clinical Director (Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Clinical Director May Be… more
- Merck & Co. (Rahway, NJ)
- …clinical/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring ... may represent the company through external partnerships, collaborations, and key strategic engagements. This includes the ability to:Solid knowledge of clinical… more
- Merck & Co. (Rahway, NJ)
- …risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen ... challenges, proactively prioritizing, interrogating and mitigating risks across technical, regulatory and operational factors.- Conducts options analysis and provides… more
- Merck & Co. (Rahway, NJ)
- …role. - Key responsibilities may include, but are not limited to: -- Strategic Planning Communications: Lead the development and implementation of digital ... experience-driven omnichannel engine across our US Animal Health portfolio. You will lead a team that owns digital demand creation and customer experience for… more
- Merck & Co. (Rahway, NJ)
- …Center of Excellence (COE) is responsible and accountable for technical leadership, strategic planning and portfolio execution of key work in support of Centers ... combination product technical expertise, a strong track record in problem-solving, strategic acumen, and execution, along with exceptional leadership skills to shape… more
- Merck & Co. (Rahway, NJ)
- …a best-in-class patient experience for IBD patients in support of the launch of our lead asset in immunology. This role will develop a deep understanding of the IBD ... adherence, and outcomes while maintaining compliance with the highest ethical and regulatory standards.- The Director will collaborate closely with the US patient… more
- Merck & Co. (Rahway, NJ)
- …Biologics- Materials and Biophysical Characterization. The successful candidate will lead our biophysical characterization group in biologics, overseeing the ... scientific and technical guidance, mentorship, and support.Develop and implement strategic plans for biophysical characterization to support the research and… more
- Merck & Co. (Rahway, NJ)
- …will possess deep technical expertise, a strong track record in problem-solving, strategic acumen, and execution, along with exceptional leadership skills to shape ... the technical capabilities and strategic direction for a global, cross-modality technical team. The...for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Logistics… more
- Merck & Co. (Rahway, NJ)
- …Microbial Fermentation, Process Analytical Technology (PAT), Process Scale Up, Regulatory Compliance, Scientific Innovation, Strategic Leadership, Strategy ... documentation of experiments for the adoption and development of innovative technologies. Lead the design and execution of bench scale process development experiments… more
- Eisai, Inc (Nutley, NJ)
- …profile, we want to hear from you. The Associate Senior Counsel, Privacy, is a strategic , business-minded, and hands-on attorney role whose job will be to lead ... Data Governance, Government Affairs, R&D, etc.) in executing both high-priority strategic initiatives (eg, data-driven platforms, AI, digital patient and HCP-facing… more
- Terumo Medical Corporation (Somerset, NJ)
- …more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We ... / 13485 / 14971, 21 CFR 50/56/812, and ICH-GCP and applicable regulatory requirements, while driving continuous improvement in clinical quality systems and… more
- SMBC (Jersey City, NJ)
- …finance functions ongoing initiative to source reference data from the firms strategic sources + Contribute to the ongoing buildout of a reference data operating ... on implementation of processes, methodologies, and systems that meet regulatory requirements and industry best practices. Within the larger...our Head Office, SMBC Finance is executing a major initiative to meet the gaps identified by the BCBS… more
