- Aequor (Thousand Oaks, CA)
- …equipment and facilities at Thousand Oaks (ATO). The engineer will lead project engineering and construction activities in alignment with the engineering workstreams ... (ie Trades during construction, project management budget, schedules, safety, and 's Commissioning and Qualification Process (CQP) to ensure that new GMP equipment… 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
- 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 external stakeholders communicating project status, escalating… 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 ... development, and management as they pertain to the IS Quality program. Project Management: Establish and/or maintain IS PMO framework and corresponding policies,… 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)
- …appropriate Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations/EU Directive, and International Conference on Harmonization (ICH) ... affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project , and quality plans, and relevant ICH/GCP Guidelines Review protocols… 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …on desk registration system- Backup to leader of Facilities Services for FDA inspections- Manage Facilities home page on intranet, review content regularly, upload ... and Support- Coordinate with leader of Facilities Services to determine project related daily/weekly tasks and responsibilities- Track and prioritize daily and… more
- Merck & Co. (Rahway, NJ)
- …systems, and coordinating CDS technical initiatives. Supporting the clinical database manager /supervisor in project planning, manpower projections, and resource ... maintain good working relationships across different functional areas. Solid project management skills. Excellent leadership, verbal and written communication,… 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 ... products over the product's life cycle. The Labeling Strategist, Manager will lead the development of the Core Labeling...Knowledge of labeling within a Therapeutic Area Knowledge of FDA , or EMA, or other international regulations for labeling… 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 ... approach, leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships with… 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
- 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
- University of Pennsylvania (Philadelphia, PA)
- … Manager Research Project A Job Description Summary The Project Manager will manage the day-to-day operations of investigator-initiated health disparities ... various funding sponsors (government, industry, foundation). The primary responsibilities of the Project Manager will range from planning and developing guidance… more
- Food and Drug Administration (Silver Spring, MD)
- …for management decisions. Requirements Conditions of Employment Qualifications The position of Project Manager falls within the 0301 occupational series. To ... position is located within the Food and Drug Administration ( FDA ), Center for Drug Evaluation and Research (CDER), Office...Executive Branch political, Schedule C, or Non-career SES appointee, HHS/ FDA may be required to obtain approval by the… more
- University of Pennsylvania (Philadelphia, PA)
- …University of Pennsylvania, FDA , and GCP standards and guidelines. The Regulatory Project Manager will report directly to the FTDC Clinical Research Program ... and resources, and much more. Posted Job Title Regulatory Project Manager (Department of Neurology) Job Profile...IV trials through the IRB, the sponsor, CAMRIS, RRSC, FDA , INDSO, and all other reviewing entities as applicable.… more
- Black & Veatch (Arlington, VA)
- ** Project Manager - Construction - Federal Services** Date: Aug 28, 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
