- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) ... provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead… more
- Eisai, Inc (Exton, PA)
- …Job Summary Implements global chemistry, manufacturing and control (CMC) regulatory strategies throughout the lifecycle of pharmaceuticals. Coordinates the ... preparation of CMC regulatory submissions that meet global regulatory requirements,...original NDAs, MAAs and Growth Market dossiers ensuring that quality documents are preparedTracks Module 3 leafs for global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …required documents to FDA.RelationshipsThe fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team throughout ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Tris Pharma (Monmouth Junction, NJ)
- …knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug-device combination ... Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …learned information flow based on read outs from audits, inspections, Quality Events, regulatory intelligence, effectiveness checks on process implementations ... learned information flow based on read outs from audits, inspections, Quality Events, regulatory intelligence, effectiveness checks on process implementations… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary: Exela Pharma Sciences is seeking an experienced and dynamic Senior Manager , IS Quality to build and lead our IS Quality function. The ideal ... and Compliance Oversight: Lead and/or participate in the operational execution of Quality and Compliance GxP processes including audits, regulatory intelligence,… more
- Aequor (Tallahassee, FL)
- …to MAX Shift/Schedules- Flex, normal dayshift hours Title (Role) Case Management - Manager Organization Global Patient Safety Intake Call Notes with HM: What are the ... oversight of all case intake processing activities and case quality including analysis and reporting of trends in ...cases in a timely manner to meet all worldwide regulatory authority requirements Provide vendors with resources and training… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …various contractors meets Global DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner with global ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Insmed Incorporated (San Diego, CA)
- …a fast paced, collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team. As the QC Stability and Sample Management ... Manager , you will be responsible for the daily oversight...support associated investigations, including: temperature excursion assessments, client and regulatory requests, and investigational testing. Assist in creating a… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory , Technical Operations and RNAi Early Development professionals at ... coordinators Conduct routine safety observations to ensure compliance with regulatory agencies, company environmental, health, and safety policies, procedures and… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders.Summary Accountable for support and manage Quality Management System (QMS) in accordance with regulatory requirements ... to ensure adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible for the creation and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development ... this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies… more
- 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 ... of data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management, lineage capabilities and the data governance processes… more
- Aequor (Austin, TX)
- Remote - EST or CST time zone preferred. MANAGER IS OPENING CAP, PLEASE SUB AT MARKET RATE! CANDIDATES MUST COMPLETE THE PRESCREENING QUESTIONS FOR REVIEW ON RESUME: ... was the dollar value of the largest project? (5) During the interview with hiring manager , you will be asked to walk through the specific steps in Ariba that you… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight:… more
- Aequor (Thousand Oaks, CA)
- …working hour availability at the top of the resume is seeking a Supply Chain Manager to be a part of our External Planning & Delivery Pre-Commercial Supply Chain ... group. The Manager will work from Remote US Location or in...the demand/supply planning and inventory management in support of regulatory filing, clinical/commercial supply, and/or product launch and lifecycle… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reviews and authoring reports and co-authoring primary and secondary sections of regulatory documents. The Manager , Clinical Pharmacology is expected to ... setting, to drive the development of potential products and drug candidates. The Manager , Clinical Pharmacology will support or take the lead on generation of study… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Associate Director, Quality Technical, is responsible for leading a team that supports deviation management, change control, site ... qualification/validation, equipment qualification, and technical support quality for sterile manufacturing of vaccines. The ideal candidate would have prior… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Job Summary The Biosample Operations Manager , Biosample Management is responsible for supporting the oversight of the ... Instructions (SOIs) to support biosample management activitiesEnsure appropriate performance and quality targets are established (via metrics and KPIs) for biosample… more
