- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trials, post-marketing and other relevant sources for the prompt identification of safety signals.Lead internal and external (especially regulatory , but also ... evaluation related documents/deliverables on time.Coordinate and participate actively in safety -related regulatory interactions (eg, regulatory meetings,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …optimize, and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance, promote ... (eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety , Regulatory Affairs, Epidemiology) to ensure benefit-risk integration… more
- Aequor (Thousand Oaks, CA)
- …systems and laboratory logbooks. Preferred Qualifications Ability to adhere to regulatory requirements, written procedures and safety guidelines Ability to ... and adaptable to changing priorities and requirements Demonstrate understanding of regulatory requirements, safety guidelines and factors impacting compliance… more
- Merck & Co. (Rahway, NJ)
- …Ensure that all activities are conducted with the highest regard for safety , quality, and regulatory compliance, aligning with the company's divisional ... alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities: Strategic Leadership and Project… more
- Merck & Co. (Rahway, NJ)
- …systems.Ensure that all activities are conducted with the highest regard for safety , quality, and regulatory compliance, aligning with the company's divisional ... alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Utilize extensive experience in design… more
- Tris Pharma (Monmouth Junction, NJ)
- …maintain optimal stock levels and minimize obsolescence; Ensures compliance with safety , quality, and regulatory standards in warehouse operationsManages, ... and assurance of compliance with GxP and other company and regulatory agency procurement policies and procedures throughout the organization. Ensures compliance… more
- Merck & Co. (Durham, NC)
- …risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen ... supply.Collaborate with Research Laboratories, Process Development, Commercialization, Operations, Quality, Regulatory -CMC, and Supply Chain teams to ensure seamless technology… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering s culture of ... compliance with GCP, GPV, GPEP, Data Protection, and other local regulatory requirements throughout the planning and execution of Interventional, Non-Interventional,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both ... and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic reporting. Contribute as a key DSI contact for PV… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading ... portfolio of products. The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be within Global … more
