- Russell Tobin & Associates (Columbus, OH)
- …Project Manager ? PrideNow is seeking a Transportation Project Manager for an environmental, engineering, and technical consulting company at either ... week to coordinate with Junior Engineers. As the Transportation Project Manager for the Great Lakes, this...on how our services can meet their needs Identify regulatory drivers for our services and build a plan… 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 ... assigned projects and roles.Essential FunctionsGeneralAll fellows will complete a fellowship project for presentation to the Regulatory Affairs department and/or… more
- Aequor (Pearl River, LA)
- Research, write, and edit technical documents such as standard operating procedures, change controls, protocols and deviations.2. Work closely with manufacturing, ... and completeness of documentation3. Provide summary reports to management and project team on the status of documentation activities4. Ensure compliance with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …their needs and factoring regional needs, laws, and requirements.- Collaborate with the Project Manager (PM), HCP Engagement IT Operations team and business ... addition, this role will streamline business requirements, evaluate, and prioritize project and change request timelines, and ensures seamless integration with… 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 ... BiomarkersSupport clinical study teams and functional working groups on technical and operational sample-related questions and/or escalations. Triage requests to… 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 ... candidate will be responsible for ensuring compliance with regulatory requirements, industry best practices and internal standards as well as managing quality… more
- Merck & Co. (Durham, NC)
- …DescriptionThe individual in this role must provide direction, coaching, and technical expertise to maintenance and instrumentation technicians assigned to start up ... participate on cross-functional teams in an inclusive manner to advance project goals and achieve deliverables.Hire, develop, motivate, and manage a team… more
- Eisai, Inc (Nutley, NJ)
- …Excellent interpersonalandcollaborativeskills with astrong customer-centricfocusare necessary. Project management with ability toplan,organize, prioritize, and ... Provide oversight of relevant technologies and platforms. Monitor industry & technical trends and recommend appropriate technologies and platforms to accommodate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... technical team in preparation of submission documents; authors regulatory documents where necessary with supervision.Health Authority Interactions: Leads US… more
- Eisai, Inc (Nutley, NJ)
- …strategic oversight of relevant technologies and platforms. Monitor industry & technical trends and recommend appropriate technologies and platforms to accommodate ... evolving regulatory requirements, user needs and business and functional requirements. Lead the development, support and rollout of relevant technologies and… more
- Merck & Co. (Rahway, NJ)
- …trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates ... This includes the ability to:Apply strong knowledge of clinical research regulatory requirements (eg, GCP and ICH)Manage multiple competing priorities with good… more
- Aequor (Thousand Oaks, CA)
- …(LSC), and under the supervision of the Therapeutic Area Lead, the Labeling Manager is responsible for supporting the facilitation and management of the end-to-end ... & post marketed products over the product's life cycle. The Labeling Strategist, Manager will lead the development of the Core Labeling documents. and US Labeling… 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
- Novo Nordisk Inc. (WA)
- 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
- Merck & Co. (Durham, NC)
- …calibration, and maintenance support for a new product feasibility project /manufacturing support. Develops standard operating procedures (SOP's) and preventative ... to the performance and results of the department Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …apply unique business insight to create competitive advantage for the organization Project Management: Works in partnership with internal and external teams to ... projects on time and budget through effective management of the project timeline, issues, risks, dependencies, and deliverables Stakeholder Engagement &… more
- Novo Nordisk Inc. (Durham, NC)
- …following activities: People Focus, Equipment Focus & Standards "Gatekeeper". Relationships Manager Technical Support - OFP. Essential Functions Support plans ... tools within the main areas of Systematic Problem Solving, process improvement, & project management Operate within compliance with a Quality Mindset that focuses on… more
- Merck & Co. (Rahway, NJ)
- …coordinating CDS technical initiatives. Supporting the clinical database manager /supervisor in project planning, manpower projections, and resource ... years of experience in clinical databases development or programming. Demonstrated technical proficiency in Clinical Data Management Systems (ie, Inform, Inform… more
- Merck & Co. (Durham, NC)
- …troubleshooting and maintenance support for a new product feasibility project /manufacturing support. Develops standard operating procedures (SOP's) and preventative ... to the performance and results of the department.Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that… more
