- Legend Biotech USA, Inc. (Raritan, NJ)
- …domestic, internal and external sites. In addition, this role will support Compliance initiatives , such as inspection readiness, metrics implementation and ... review, overall regulatory compliance and implementation programs, and others...provide commuter benefits, family planning and care resources, well-being initiatives , and peer-to-peer recognition programs - demonstrating our ongoing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Director , Engineering as part of the Technical Operations team based in ... Raritan, NJ. Role OverviewThe Associate Director of Engineering is a strategic and operational leader...and systems support business goals and comply with safety, regulatory , and sustainability standards. This position is a key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... data and external data, CDASH/SDTM, industry best practices, and relevant regulatory requirements is essential. This position demands significant skills in working… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Sr. Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and ... initiatives for continuous quality improvement.Deputize for the Sr. Director , Medical Affairs QA as needed. Cross-functional and Global Team Participation:Drive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management processes across the global safety organization. The incumbent will ensure regulatory compliance , promote best practices, foster a culture of ... activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and… more
- Merck & Co. (Rahway, NJ)
- …stakeholders.Demonstrated ability to lead and drive results/impact for critical business/ compliance initiatives .Demonstrated ability for process improvement and ... compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.Ability to travel globally approximately 20-30% of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for patient support field teams. This role will oversee program operations, compliance , vendor contracts and relationship management. AD will drive collaboration and ... functions, including Commercial Strategy and Marketing, Insights & Analytics, privacy, compliance and legal. Relationships The position reports to the Director… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …together to change lives for the better. The Position The Associate Director , Consumer Social Media Strategy is a high-impact, hands-on leadership role responsible ... and optimization of all consumer-facing content and corporate social media initiatives that support business and commercial priorities. This role translates the… more
- Merck & Co. (Rahway, NJ)
- …as product lifecycle management for drug-device combination products.Reporting to the Sr. Director of Device Product Assessment & Innovation (DPAI), the Director ... early development. They will lead various early development and innovation initiatives to support continuous improvement that translates DPAI strategy and objectives… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Monitor internal workflows and performance metrics to ensure departmental KPIs and regulatory compliance are consistently met Audit & Inspection Readiness ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...relationships within Intake and Triage, Medical Review, Submissions and Compliance , Global Safety, and centralized teams (eg, Training and… more
- Merck & Co. (Rahway, NJ)
- …are currently seeking a Cardiovascular & Respiratory Competitive Intelligence Director specializing in PAH, COPD, and other cardiopulmonary diseases. This ... strategies, portfolio prioritization, clinical development/research strategies, and Business Development initiatives .Partnering with discovery and clinical colleagues to shape research… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .Essential Duties and Responsibilities:Program Leadership and Technical ... Job DescriptionThe Associate Director - Device Tech Transfer is a leadership role...conducted with the highest regard for safety, quality, and regulatory compliance , aligning with the company's divisional… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities: Strategic Leadership and Project ... Job DescriptionJob Summary: The Director , Combination Product Commercialization is a key leadership...of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance: Ensure that… more
- Merck & Co. (Rahway, NJ)
- …Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance , Regulatory Labeling, Regulatory ... minimum of 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated… more
- Merck & Co. (Rahway, NJ)
- …Recruitment, Process Analytical Technology (PAT), Professional Networking, Raw Materials, Regulatory Compliance , Regulatory Submissions, Release Testing, ... entirety of our non-sterile and sterile clinical portfolio. The Director is responsible for ensuring cGMP compliance ...a state of inspection readiness at all times. The Director should be well engaged with regulatory … more
- Merck & Co. (Rahway, NJ)
- …drug substance and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support ... Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director ...life cycle changes, investigations, trouble shooting and continuous improvement initiatives to guarantee the robustness and compliance … more
- Merck & Co. (Rahway, NJ)
- …construction and campus planning?- Have you advised on design standards, project scope, and regulatory compliance as well as act as a liaison with internal ... and building design standards, open space and site planning guidelines, and regulatory compliance such as ADA, environmental, and building codes.Ensure quality… more
- Merck & Co. (Rahway, NJ)
- …Logistics, Multiple Therapeutic Areas, Process Optimization, Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines, strategies and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director of Human Factors (HF) will provide visionary leadership and strategic direction for the HF function within our company. This role ... principles to enhance patient safety and product usability. The Senior Director will champion enterprise-wide HF strategy, foster cross-functional collaboration, and… more
- Merck & Co. (Rahway, NJ)
- …and assembly equipment standards, technical lifecycle management, and continuous improvement initiatives to guarantee the robustness and compliance of our ... Job DescriptionDir, Engineering - Director , Assembly and Packaging Platform Technical LeadershipReporting into...internal technical requirements are achieved and ensure filings with regulatory bodies to ensure compliance with relevant… more
