- 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
- 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
- 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)
- …building monitoring systems and laboratory logbooks. 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
- 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. (Millsboro, DE)
- …Operations, Manufacturing Quality Control, Media Preparation, Process Improvements, Regulatory Compliance, Safety Practices, Standard Operating Procedure ... people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in the… more
- Merck & Co. (Durham, NC)
- …coaching of the team (eg documentation, housekeeping, area 5S, etc.)-Participate in safety / regulatory audits (ie tours, topic discussion)-- Financial- Coach the ... to provide area/process overview information to visitors/auditors upon request-- Quality & Safety Compliance- Foster strong safety culture on the team through… 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
- 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
- City of Spring Hill Kansas (Spring Hill, KS)
- …inspections. Analyze architectural plans and specifications to ensure they meet safety and regulatory standards. Perform field inspections on industrial, ... skills. Oversee building code compliance, managing inspections and ensuring safety standards in construction projects. Ensure compliance with federal, state… more
- Repligen (Rancho Dominguez, CA)
- …GED, or equivalent required.Fluency in English (reading and writing) required due to safety and regulatory requirements.Minimum of 1-2 years of experience in ... medical device assembly.Proficient in the use of hand tools, power tools, and test equipment.Solid understanding of basic computer applications.Physical Requirements:Regularly required to stand, walk, use hands to handle or feel objects, and communicate… more
- Merck & Co. (PA)
- …is a member of the Product Stewardship team under GSE (Global Safety and the Environment). The successful candidate will demonstrate expertise and technical ... knowledge in Safety Data Sheet authoring tools and EHS data maintenance...project activities and monitor project metrics.Provide support related to Regulatory updates as required.Support the business in managing product… 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)
- …support and training to mechanics and other maintenance personnel.Interface with safety , production, and quality groups to ensure facility operations and systems ... systems, procedures and ways of working with a focus on safety , current Good Manufacturing Practices (cGMP) compliance and efficiency.Define requirements and… more
- Merck & Co. (Rahway, NJ)
- …characterization such that the process is scalable without compromising stability, safety , efficacy, and delivery. During development, we leverage smart experimental ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings. Collaborate with key stakeholders across the organizations… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will be… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... of clinical development, including study design, initiation, execution,-monitoring, analysis, regulatory reporting, publication, and presentation at national and international… 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
- Merck & Co. (Durham, NC)
- …innovative technical solutions and operational improvements to achieve targets for safety , compliance, supply, and productivity for the product franchise.This role ... strong and trusting relationships with site technical operations, quality, regulatory , stability, and other stakeholders to ensure effective communication of… more
