- 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)
- …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)
- …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)
- …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)
- …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)
- …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)
- …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)
- …accessibility across the complex clinical development ecosystem. Reporting to the BIA team lead , the Senior Specialist / Information Architect will play a key role ... data and data standards across Clinical Development, Medical Affairs, and Regulatory Affairs domains. Apply domain knowledge to influence system design,… 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
- Novartis Group Companies (East Hanover, NJ)
- …Director, Evidence Generation TA Head - Oncology. This leadership role will lead an Evidence Generation TA team supporting Oncology, driving a robust evidence ... Collaborations (RCs) for population health initiatives as well as ensures strategic alignment for all US access-related Medical efforts in close collaboration… more
- Selective Insurance (Short Hills, NJ)
- …must be carried out in compliance with applicable legal and regulatory requirements. Responsibilities * Provide line of business technical expertise to ... of business. Qualifications Knowledge and Requirements Must be able to lead project teams; excellent customer service, networking and relationship building skills;… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready ... with a less traditional background. **Job Description** The Group Lead , Supply Chain CoE - North America will ...practices and competitors. **5. Program Management Office (PMO) & Initiative Deployment** - Oversee PMO functions to ensure successful… more
