- Merck & Co. (Lower Gwynedd, PA)
- …maintained in a validated state, as part of an active/ongoing lifecycle management program and in compliance with current GXP requirementsUse technical knowledge ... activities and all other associated Quality functionsUnderstands and applies regulatory / compliance requirements relative to their role.Experience working within… more
- Merck & Co. (Durham, NC)
- …meet established delivery timelinesProvide active support during audits and inspections ( regulatory , internal, safety)Collaborate with site compliance team to ... with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract… more
- Merck & Co. (Durham, NC)
- …Specialist, Quality Operations (QO) is accountable for maintaining regulatory compliance for the Environmental Monitoring (EM) program . The role will ... A minimum of 6 months in a quality function that supports compliance , release and/or environmental monitoring supporting a GMP manufacturing facility/ utilities.… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Merck & Co. (Rahway, NJ)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction ... partners, this individual will support late stage and commercial large molecule program activities within CCFS. The individual will be responsible for leading a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …existing CMR employee on-boarding, cultural engagement, technical/role-specific training and GxP/ Regulatory compliance across CMR functions. Position will serve ... execution, maintenance of technical training across all CMR functions, and compliance across clinical development, medical, and regulatory roles/processes/SOPs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality Leads (RQLs), ... the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from...the quality landscape across regions. This may include assessing regulatory intelligence and industry best practices and sharing with… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …and inhaled dosage forms.Provide active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations (Research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Excellence and Innovation, as well as Therapeutic Area leads, Sales, Patient Support Program , CIA&A, Medical, Legal, and Regulatory and IT. Essential Functions ... into actionable marketing strategies to guide customer experiences Understanding of regulatory , compliance , and ethical considerations in engaging with… more
- Merck & Co. (Millsboro, DE)
- …and unregulated species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for ... the animal facilities as well as for the veterinary care and animal husbandry program at our company's Millsboro Animal Health facilities. This role is highly … more
- Merck & Co. (Rahway, NJ)
- … regulatory documentation. Active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings. Have deep fundamental knowledge around large molecule… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …QA Compliance , is responsible for managing the Supplier Quality Program at Exela ensuring timely completion of associated activities and ensuring accurate ... in compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration.Job Responsibilities Oversee and… more
- Merck & Co. (Lower Gwynedd, PA)
- …regulated (preclinical and clinical) assays and have experience in supporting regulatory submissions and responses. - The incumbent will be responsible for ... robotic automation and IT innovative solutions to influence general and program -specific assay development, implement robotic solutions, deploy updated or new LIMS… more
- Aequor (Swiftwater, MN)
- …reagent program , which includes inventory management, international shipping in compliance with Regulatory Affairs. Also support the assay lifecycle ... compendial compliance method transfers method validation support Assay Lifecyle Program The main responsibilities will be to support the reference standard and… more
- Tris Pharma (Monmouth Junction, NJ)
- …materials, activities and related communications and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, ... marketing and other cross-functional teams (ie, Medical Affairs, Sales, Regulatory Affairs, Operations, etc.)Collaborates closely with Analytics team to establish,… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key Ofunctions.Lead the Device Development… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... expertise in several areas, including: -Responsible for achieving results on major program drivers by implementation of one or more novel quantitative approaches… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Technically independent and maintains up-to-date knowledge of industry standards and regulatory compliance requirements and independently contributes to the ... an FDA, EMEA, GMED or TGA regulated production facility Knowledge of GMPs, Compliance and Regulatory requirements is essential Excellent communication skills and… more
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