- BioAgilytix (Durham, NC)
- As the IT Project Manager at BioAgilytix, you will lead and manage cross-functional IT projects spanning business systems, laboratory systems (ELN, LIMS), and IT ... within budget, and aligned with business needs. This role requires a versatile project manager with a proven track record of delivering high-impact projects… more
- Daiichi Sankyo, Inc. (Bernards, 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 (GRL), US… more
- Merck & Co. (Upper Gwynedd, PA)
- …and Head of Clinical Quality Operations (HCQO), the Clinical Quality Operations Manager (CQOM)} is responsible for the execution of operational quality activities ... such as the United States of America Food and Drug Administration ( FDA ), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency,… 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 ... to make a difference? The Position The HEOR Strategy and Evidence Synthesis Manager will be part of the HEOR Evidence Synthesis and Strategy (HEOR-ESS) sub-team.… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …during preparation and review of regulatory documents As assigned, participate in project teams Assist with technical preparation for FDA meetings, including ... comments to assure that documents are accurate and complete and comply with FDA regulations Works with manager to gather internal intelligence including tracking… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process for validated systems where necessary.Maintain effective communication with project stakeholders.- Provide oversight to assure that all validation work ... related to pharmaceutical operations. required- 1 or More Years Direct dealings with FDA , EMA, PMRA, other regulatory agencies. preferred- 1 or More Years Strong… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents where necessary with supervision.Health Authority Interactions: Leads US FDA /EU EMA interactions with support from higher-level manager .Regulatory ... This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the...the company liaison with the Health Authority (eg, US FDA and EU EMA) for assigned projects with support,… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …improvements.Assure regulatory compliance and technical feasibility of proposed changes.Serve as project manager for the change process and provide coordination ... ensuring consistent quality standards are maintained.Key Responsibilities Support area Manager and work closely with investigators to ensure investigations are… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Division of the Company. [Specific assignments to be determined by direct manager of the role.]- Creates, implements, and presents training programs and materials ... and other business leaders with updates regarding same.- Leads cross-functional project management teams set up to address mid-sized to large Company-driven… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …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. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... insights from the marketplace. This role may also lead the Core Medical Team, Project Team (co-chair), and National Advisory Board meetings for a Therapeutic Area in… more
- Prometheus Federal Services (Washington, DC)
- Project Manager (Food and Drug Administration)...services agencies, has an opening for Project Manager with Food and Drug Administration ( FDA ) ... Consulting experience. You will work closely with and support FDA agency clients in the planning and implementation of...not an IT role. Essential Duties and Responsibilities The Project Manager will be responsible for leading… more
- Texas State University (San Marcos, TX)
- …various functions such as serving as program lead, assigning tasks and helping coordinate the FDA project and tasks of multiple FDA Contract Specialists. Job ... of Federal Tobacco Regulations + Demonstrated experience in leading project teams + Experience giving instructional presentations in a...The Program Coordinator will work closely with the Program Manager ( FDA State Program Coordinator) to… more
- Food and Drug Administration (IN)
- …of Regulatory Project Management (DRPM). Responsibilities Serves as a Regulatory Health Project Manager and Technical Project Lead (TPL) for a ... Health and Human Services (DHHS), Food and Drug Administration ( FDA ), Center for Tobacco Products (CTP), Office of Science...Conditions of Employment Qualifications The position of Regulatory Health Project Manager (Technical Project Lead… more
- Colorado State University (Fort Collins, CO)
- …and scalability issues. Position Summary Under the supervision of the Director and Senior Project Manager , the Project Manager III is responsible ... well as to support BioMARC's overall facility and business operations. The Project Manager is responsible for multi-institutional client and external… more
- Food and Drug Administration (Silver Spring, MD)
- … project resources. Requirements Conditions of Employment Qualifications The position of Project Manager falls within the 0301 occupational series. To qualify ... Health and Human Services (DHHS), Food and Drug Administration ( FDA ), Office of the Commissioner (OC), Office of the...to maintain or improve the quality and quantity of project operations and services, introducing or refining automated systems,… more
- Black & Veatch (Arlington, VA)
- ** Project Manager - Construction - Federal Services** Date: Oct 26, 2024 Location: Arlington, VA, US Company: Black & Veatch Family of Companies **Together, we ... put your diverse talents and perspectives to use. \#LI-TF1 **The Opportunity** As the ** Project Manager (Construction) for Federal Services** , you will have the… more
