- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... Records, Electronic Signatures o 21 CFR § 312.32: IND Safety Reports o FDA Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriate Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations/EU Directive, and International Conference on Harmonization (ICH) ... guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and...performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all Global ... appropriate Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations/EU Directive, and International Conference on Harmonization (ICH)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and qualification and Computer Software Assurance (CSA), SDLC related to pharmaceutical operations . required- 1 or More Years Direct dealings with FDA , ... appreciation of the impact of regulatory bodies on pharmaceutical operations . preferred- Experience auditing software vendors is preferred. preferred- International… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to FDA .RelationshipsThe fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team throughout the one-year ... health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support… more
- Aequor (Thousand Oaks, CA)
- …years of relevant work experience with 1&plus years' experience in operations /manufacturing environment Direct experience with regulated environments ( FDA , OSHA, ... EPA, etc.) Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments and equipment Experience implementing risk-based verification on major GMP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …master batch records, forms, and support and manage change controls.Work closely with Operations Manager to help oversee the development of production personnel, ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Operations Supervisor (1st shift) as part of the Technical Operations team… more
- Insmed Incorporated (San Diego, CA)
- …join the Quality Control leadership team. As the QC Stability and Sample Management Manager , you will be responsible for the daily oversight for the QC stability and ... sample management operations in support of routine GMP operations ...development.Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA ) as they relate to drug substance and drug… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe ... QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...environment. This role will also provide oversight of technical operations activities including data or document review, risk assessments,… more
- Merck & Co. (Lenexa, KS)
- …response to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies.The successful candidate for this position will ... event reporting, dealing with Ruminant health issues in customer's operations , customer complaints and education on new products from...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... two-year program and will also have a reporting relationship with a manager /preceptor in the respective functional areas during their rotations. Additional key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Facilities Management. Daily tasks and areas of support are determined by the Manager Facilities Services based on demand of each functional area, and the individual ... area by complying with procedures, rules, and regulationsExecute the daily operations of the corporate reception area, including safety procedures and in-house… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …brand attorney and the primary legal advisor for the commercial business and operations supporting US approved (or to be approved) oncology products and to specific ... and lead legal advisor for the commercial business and operations supporting US approved (or to be approved) oncology...the Company. [Specific assignments to be determined by direct manager of the role.]- Creates, implements, and presents training… more
- Novo Nordisk Inc. (WA)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... approach, leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships with… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Relocation assistance is available for selected candidate.RelationshipsReports to: Manager , Compliance & InvestigationsNumber of subordinates with direct/indirect ... owner will lead the investigation of deviations that occur in operations and perform technical writing of investigationsAuthor and manage the investigations… more
- Merck & Co. (Rahway, NJ)
- …and coordinating CDS technical initiatives. Supporting the clinical database manager /supervisor in project planning, manpower projections, and resource allocation ... independently, and communicate effectively. Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... company goals. RelationshipsThe fellow will report to the fellowship track manager during the one-year program. Additional key internal relationships may include… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …or material handling tasks in a backup role, as needed. Updates supervisor/ manager of work status or problems with recommendations for improvement or correction. ... Relationships: Works in a collaborative team setting with quality and operations counterparts that include Manufacturing Operations , Quality Assurance,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.Key Responsibilities Perform peer review/approval ... the safety policies, quality systems and cGMP requirements. Immediately alerts supervisor/ manager when data discrepancies are identified. Job duties performed may… more
- University of Colorado (Aurora, CO)
- …**University of Colorado Anschutz Medical Campus** **Department: Clinical Research and Operations Services** **Job Title: IND/IDE Office Program Manager ** ... value-added recruitment advertising agency (https://www.jobelephant.com/) The IND/IDE Office Program Manager within the Office of Clinical Research Operations … more
