- 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 ... conjunction with the Director of Data Stewardship, Cataloging and Process , develop implement a data stewardship community and set...o 21 CFR § 312.32: IND Safety Reports o FDA Guidance for Clinical Investigators, Sponsors, and IRBs -… 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 ... as well as those who are part of the promotional review process .External relationships include potential interaction with FDA personnel regarding assigned… 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...safety communications, DSUR, IND.Lead the CRO and vendor selection process in collaboration with the study team and outsourcing… more
- Lundbeck (Philadelphia, PA)
- …and transform lives. Join us on our journey of growth! As a Neuroscience Account Manager , this is an incredible opportunity to join the growing promotion of our CNS ... accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED… more
- Lundbeck (MA)
- …transform lives. Join us on our journey of growth!As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED… 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...with responsibilities for providing quality oversight for the manufacturing process , equipment, and associated deviations and investigations within a… more
- Aequor (Thousand Oaks, CA)
- …manufacturing plant and engineering group, This person needs to have process /utility Engineering technical experience and not only be quality background driven. ... construction, project management budget, schedules, safety, and 's Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and… 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) ... Access Program (MAP)/(EAP)Support the oversight of the overall global oncology review process of PhIV company sponsored studies per the Standard Operating Procedure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(IQ/OQ/PQ), Test Scripts and Summary Reports.Support the change management process for validated systems where necessary.Maintain effective communication with ... and participates in SDLC Lessons Learned sessions to evaluate validation process improvements and efficiencies and measure key success factors.- Drive continuous… 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 ... of drug development.Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA ) as they relate to drug substance and drug product stability… 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 ... inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here...you need an accommodation during the application or hiring process . We are an Equal Opportunity Employer, committed to… 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)
- …with manager to ensure all procedures are followed to process visitors and maintain appropriate records of activitiesComplete corporate projects including ... tasks and areas of support are determined by the Manager Facilities Services based on demand of each functional...For example: Training center and divisible room requirements for FDA and training department - manage the reassignment of… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …is responsible for investigating and writing of deviations to the manufacturing process and other operational problems as assigned. This position is responsible for ... site. Relocation assistance is available for selected candidate.RelationshipsReports to: Manager , Compliance & InvestigationsNumber of subordinates with direct/indirect referral:… more
- Merck & Co. (Rahway, NJ)
- …multi-task, work independently, and communicate effectively. Understanding of drug discovery process , FDA regulations, GxP guidelines, ICH guidelines, clinical ... specifications. You'll be expected to uphold our clinical database standards, SOPs, and Process Guidelines. You will have the opportunity to lead and participate in… 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 ... rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance) for monitoring and site management activities. Takes ownership… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Lead and supervise multiple units within the CAR-T process operations (ie component preparation manufacturing, MFG support operations, Mock ... cell, and CAR-T process ) according to standard operating procedures and batch records...and support and manage change controls.Work closely with Operations Manager to help oversee the development of production personnel,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for reviewing all data produced by the Quality Control Lab during In- Process and release Drug Product QC Testing, related to the manufacturing of cell ... the safety policies, quality systems and cGMP requirements. Immediately alerts supervisor/ manager when data discrepancies are identified. Job duties performed may… more
- Novo Nordisk Inc. (Durham, NC)
- …production goals, while adhering to applicable cGMPs & SOPs. Relationships Shift Manager . Essential Functions Setup, operate, monitor & control equipment, systems & ... in the role/relevant area in lieu of work experience FDA regulated industry & solid dose manufacturing experience preferred...- 230 am. We commit to an inclusive recruitment process and equality of opportunity for all our job… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …resources and information from established internal contacts; consults with Supervisor/ Manager for decisions outside established processes.Provide guidance to other ... compliance, clinical quality, or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to GMP manufacturing of biopharmaceutical. Experience in… more
