- Merck & Co. (Rahway, NJ)
- …cross-functional colleagues to create innovative and intuitive-to-use products and ensure regulatory compliance through risk management. The cross functional ... ensure the management and maintenance of documents, records and databases that support regulatory compliance (such as human factors study protocol and report,… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... expected, as well as advancing a culture of scientific excellence and compliance mindset.Essential Knowledge, Duties & Responsibilities for the Director… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …under GLP,GCLP. Translational research Oncology, precision medicine and other research relevant duties under the RDPV QA function to ensure that Quality assurance ... Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Good Documentation Practices (GDocP)Supervise Finishing activities to ensure operational efficiency, regulatory compliance , safety and production goals are met ... compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration. Job Responsibilities:Ensure/adhere… 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 ... on programsMentor and/or supervise junior colleagues to perform the above duties and to develop the above capabilitiesLeverage significant pharmacometric and subject… more
- Tris Pharma (Monmouth Junction, NJ)
- …capabilities, when needed. The incumbent ensures timeline, quality and compliance with applicable Standard Operating Procedures (SOPs)/current Good Manufacturing ... priorities. She/he also reviews and approves all scientific, technical and regulatory packages per International Council for Harmonization (ICH)/Food and Drug… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …in compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration. Job Responsibilities: Comply ... paperworkEnsure self and finishing team members are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety, environmental… more
- Merck & Co. (Rahway, NJ)
- …of tumor size and survival.Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring ... regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs),...meetings.Mentoring and/or supervising junior staff to perform the above duties and to develop the above capabilities. Minimum education… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …in compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration. Job Responsibilities:Maintain ... prep processMaintain personal training compliance status and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety, environmental… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and procedures.Demonstrates willingness to learn new skills as required.Available for other duties as required. Ensures site compliance with all local, state ... Serves as SME on engineering design projects; sets project requirements, evaluates compliance with project and engineering standards, and approves final designs and… more
- Merck & Co. (Rahway, NJ)
- …non-sterile and sterile products.- It also includes strategic partnering with CMC and Regulatory in aspects of control strategy and filings, Quality and our partners ... oral, and specialty dosage formulations.- The director should be well engaged with regulatory and industry trends to guide future activities for Analytical R&D and… more
- Novo Nordisk Inc. (Indianapolis, IN)
- …SOPs and working practices Complies with all guidelines, policies, legal, regulatory , and compliance requirements Ensures effective administrative management of ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...as needed based on territory archetypes. Essential Functions Administrative Duties : Completes administrative duties in an accurate… more
- Aequor (Thousand Oaks, CA)
- …including analysis and reporting of trends in quality measures Ensure vendor compliance with approved processes and training requirements Audit & external inspection ... cases in a timely manner to meet all worldwide regulatory authority requirements Provide vendors with resources and training...within the remit of role and responsibility Performs other duties related to the position as necessary as defined… 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
- 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 ... at our company's Millsboro Animal Health facilities. This role is highly compliance -driven in accordance with State and Federal regulations as applicable to the… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be ... compounds, and the further study of marketed compounds. In executing these duties , theSenior Director may:Supervise the activities of Clinical Scientists in the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …in compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration.Job Responsibilities Oversee and ... as needed Ensure self and direct reports are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety, environmental and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …requirements.Strive to reduce non-conformances in supported areas by dedicatedly driving compliance .Ensure readiness of records for regulatory inspections and ... responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.Key Responsibilities… more
- Merck & Co. (Rahway, NJ)
- …level as well as at regional and local level for the NORAM region. Duties and Responsibilities include, but are not limited to: Develop and execute category ... with key suppliers to maximize supplier performance, ensure contract compliance and delivery of contractual commitments, and optimize supplier capabilities… more
- Aequor (Devers, TX)
- …Manufacturing Operations and will also be part of CTGM IT Leadership Team. DUTIES AND RESPONSIBILITIES: Lead a matrixed organization composed of both site direct ... Disaster Recovery/Service Continuity, etc. Provide IT leadership to site regulatory inspection readiness and data integrity initiatives. Participate in high-level… more
