- Merck & Co. (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for...plans, settings) based on these clinical development strategiesMonitoring and managing the conduct of ongoing or new clinical trials… more
- Insmed Incorporated (NJ)
- …requires a blend of technical expertise and business acumen to ensure regulatory compliance , system integrity, and alignment with business objectives across ... focus on Compliance -related systemsTechnical knowledge of LMS applications, compliance business, and IT infrastructurePrevious experience managing computer… more
- Insmed Incorporated (NJ)
- …review and approval process. You will ensure efficient coordination of MRC activities, compliance with company policies and regulatory standards, and the quality ... and for the future of science, we're in. Are you?About the Role:The Associate Director , Medical Review Committee (MRC) Operations is responsible for managing the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audit activities which includes mock pre-approval inspections, routine ongoing GMP compliance audits and GMP regulatory inspections. Support the establishment, ... Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or CMOs. The incumbent… more
- Insmed Incorporated (NJ)
- …responsible for creating and implementing programs that ensure workplace safety, regulatory compliance , and environmental protection for all Insmed locations.Key ... consultants for instruction in subjects relating to health and safety and regulatory compliance (laws, regulations, requirements). Ensuring the proper execution… more
- Eisai, Inc (NJ)
- …strategies that deliver cost efficiencies, enhance vendor performance, and ensure compliance with regulatory and corporate standards. This role manages ... processes and partner with Vendor Risk Assessment teams to ensure compliance with regulatory requirements and alignment with corporate objectives.Applies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …capabilities. We're responsible for regulating accounting, upholding workplace safety, managing our supply chain and sampling, supporting technological and data ... ultimately negotiated with assigned accounts. Relationships Reports to the Executive Director / Director on the Strategic Pricing and Contracting team. Works… more
- Merck & Co. (Rahway, NJ)
- …livestock (beef, dairy, swine, poultry, aquaculture). Reporting to the Executive Director , Channel Operations & Engagement, you will connect brand teams, ... marketing teams within the organization along with sales, product development, regulatory affairs, customer service, and other cross-functional teams to ensure an… more
- Insmed Incorporated (NJ)
- …Marketing Cloud initiatives with commercial strategy, data governance, and compliance policies (including privacy, consent, and regulatory requirements).Provide ... of science, we're in. Are you?About the Role:We're looking for an Associate Director , IT Marketing Technologies, on the Information Technology team to help us expand… more
- Merck & Co. (Rahway, NJ)
- …within the Device Development team and with external partners.Understand and apply regulatory and compliance requirements relevant to device risk management ... implementing risk control measures, and performing overall device risk evaluations in compliance with ISO 14971 and other relevant standards. Ensure alignment with… more
- Insmed Incorporated (NJ)
- …to the development and review of regional/global policies and procedures. Ensure compliance with all Company/ Regulatory requirements & TMF quality standards.Work ... such conduct (including, but not limited to, ICH / GCP and regulatory requirements).Experience managing staff and providing oversight of department… 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 ...and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal… more
- Merck & Co. (Rahway, NJ)
- …DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development (DPPD) Team ... products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in support of our pipeline ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in… more
- Cipla (Central Islip, NY)
- …relationships, negotiating favorable contracts, identifying cost-saving opportunities, and maintaining compliance with regulatory and company policies. Success ... Job Title: Director - Procurement, Cipla North America Reports to:...resolve any issues or disputes that may arise. Ensure compliance with regulatory requirements, industry standards, and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE, the Director ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic ... clinical programs across various therapeutic areas and phases (I-IV), ensuring compliance with global regulations, delivering on timelines and budgets, and driving… more
- Repligen (Waltham, MA)
- …our Manufacturing, Quality, Supply Chain, Product Development, and R&D organizations. As a Director of IT, you will play a key role in aligning technology ... implement, and optimize technology solutions that enhance operational performance and compliance . The ideal candidate brings deep knowledge of the bioprocessing… more
- Insmed Incorporated (NJ)
- …(CSV) program. This role will manage cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The ... ensuring alignment with the company's values, business priorities, and regulatory commitments.Present cybersecurity posture, emerging threats, and key initiatives to… more
