- Russell Tobin & Associates (Columbus, OH)
- What are we looking for in our Transportation Project Manager ? PrideNow is seeking a Transportation Project Manager for an environmental, engineering, and ... to coordinate with Junior Engineers. As the Transportation Project Manager for the Great Lakes, this candidate will lead...on how our services can meet their needs Identify regulatory drivers for our services and build a plan… more
- Creative Financial Staffing (Columbus, OH)
- …meets a fantastic quality of life. The Role: As our Accounting Manager , you'll be the driving force behind our financial stability, overseeing all aspects of ... with grace. Financial Expertise: In-depth knowledge of accounting principles and regulatory compliance. Requirements For The Accounting Manager : Strong… more
- Aequor (Thousand Oaks, CA)
- …registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs ... Title: Regulatory Project Coordinator (RPC)Job Description: o Assist Regional Regulatory Representative to support regional regulatory activities (eg… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global ... and optimizing the defined, R&D data governance approach to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is ... responsible to support Clinical Inspection Readiness (IR) and pre-approval Inspection preparation...or More Years Strong knowledge of ICH-GCP relating to regulatory guidelines, and quality management principles. requiredExpert… more
- Merck & Co. (Durham, NC)
- …the team finishes the design and construction of the facility, the Operations Manager will play a critical role in supporting the Global Engineering Services team, ... to meet immediate business objectives even through adversity. This role will support drug product in regulated, clean room environments complying with current Good… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Senior Manager , Alzheimer's Disease - Site of Care Marketing will assist with the development and ... CRC team and agency partners.Assist with the execution of the CE Program to support the education of infusion centers. This work stream will involve partnering with… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Quality Management System and GMP Compliance Programs to assure product quality , integrity and compliance with regulatory guidelines and internal/global ... release documentation. Participates as a cross-functional team member to provide product quality /GMP support and assures proper documentation of drug product… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …deliverable quality , and expedite the preparation of oncology compound regulatory submission. It will also to maintain institutional knowledge across oncology ... of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses and help submission team… more
- Merck & Co. (Durham, NC)
- …This individual must actively manage his/her team to reliably support customer demand (including employee development, routine coaching sessions, recognition, ... procedures to resolve process/equipment issues, minimize downtime, and ensure product quality .- This role actively supports, participates, and embraces an inclusive… more
- Aequor (New Brunswick, NJ)
- …organizations functions and support systems (manufacturing, packaging, artwork, regulatory , marketing, quality , and supply chain) Knowledge of end-to-end ... onsite required for training and once done min 50% required onsite as per manager .Job Summary:The primary function of this role is to lead / participate in a… more
- Insmed Incorporated (San Diego, CA)
- …documentsKnowledge of analytical instrumentationExcellent critical thinking skills to support quality decision-makingExcellent written and verbal communication ... technical documentsKnowledge of analytical instrumentationExcellent critical thinking skills to support quality decision-makingExcellent written and verbal communication… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including SDTM and collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global submissions as ... well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …contracting agreements. In collaboration with the Associate Director, the Associate Manager will support CMR's partnership and alliance contract management ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved.… more
- Aequor (Thousand Oaks, CA)
- …of experience. Travel required about 1 week a month - multiple short trips. In support of 's Quality Assurance program manages and oversees the operations of a ... group. Ability to evaluate documentation/ operations according to company and regulatory guidelines Ability to interact with regulatory agencies. Demonstrate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug ... this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. ... As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… 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 ... Overview The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...operations Assist in the development of process, operational, and quality improvements for manufacturing Support manufacturing and… more
