- Merck & Co. (Rahway, NJ)
- …General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the… more
- Aequor (Athens, GA)
- …equipment used in clean utilities. Ensure all maintenance activities comply with regulatory standards and safety protocols, including cleanliness of assigned ... the onboarding, it goes to the original schedule, Team B, 2nd shift Regulatory and/or Organizational Requirements: Must be able to perform work according to national… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and efficient utilization of the warehouse space. This individual will assist in regulatory inspections, perform safety and quality audits, and answer relevant ... Support the optimization and efficient utilization of the warehouse space.Assist in regulatory inspections, perform safety and quality audits, and answer… more
- Insmed Incorporated (San Diego, CA)
- …technology transfers and mentoring junior staff. Maintaining laboratory equipment, ensuring safety and regulatory compliance, and supporting audits are also ... technical issues. Contributes to method qualification and validation according to regulatory guidelines such as ICH, FDA, and cGMP, evaluating method characteristics… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …and curation, as well as 3) careful development of and adherence to study regulatory and safety procedures. These responsibilities involve working in the MRI ... environment as well as collection of biological samples (e. g. blood).QualificationsRequires a high school diploma or equivalent and 2 years of relevant experience; or an equivalent combination of education, training and/or experience from which comparable… more
- Twist BioScience (South San Francisco, CA)
- …Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on Safety Data Sheets ... global product compliance, ensuring that all documentation accurately reflects regulatory requirements and product specifications.What You'll Be Doing Initiate,… more
- Merck & Co. (Rahway, NJ)
- …Assurance: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 Management:Provide… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety , pharmacovigilance included regulatory document reviewMust have at ... audits effectively.Support inspection readiness by preparing clinical teams, Clinical Safety and Pharmacovigilance (CSPV) and post marketing stakeholders for key… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Call Center, Enterprise Insights, Supply Chain, Procurement, Public Affairs, Public Policy, Regulatory , Legal, IT, Trade, Patient Safety and Compliance. External ... relationships include affordability program vendors. Essential Functions Partners with vendors and oversees development of program business rules and operations Collaborates with cross functional partners to facilitate program setup and tracking Oversees… 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 ... clinical development, including study design, initiation, execution,- monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
- Merck & Co. (Rahway, NJ)
- …and regulatory postureDemonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC.- Strong experience in safety and environmental ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Genmab (NJ)
- …methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role ... analyses requiring advanced statistical methodologies/techniquesRepresent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or… more
- Merck & Co. (Rahway, NJ)
- …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 (Research… 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
- Merck & Co. (Durham, NC)
- …well-being, and performance.- We are a global team of Environmental Health and Safety (EHS) professionals working collectively within the company to make a positive ... The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, corporate standards, policies, and procedures related to EHS as… 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. (Millsboro, DE)
- …departmentsReview and revise processes and procedures against corporate and regulatory policies.Review production records for completeness and compliance to ... Procedures (SOPs).Provide training to personnel to stay current with all regulatory agencies and corporate policies.Evaluate personnel and machinery requirements and… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible ... and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports,… more
