- Novo Nordisk Inc. (Plainsboro, NJ)
- …the most diverse and collaborative groups within the organization. From health -care-provider interactions and developing and implementing regulatory strategies ... packages for FDA meetings (pre-IND, EOP 2, pre-NDA, pre-BLA) for review by Project Leaders Write Regulatory documents translating team strategy into … more
- Merck & Co. (Rahway, NJ)
- …and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS ... Areas, Portfolio Management, Process Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance,… more
- Merck & Co. (Rahway, NJ)
- …arms within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans ... functions supporting pipeline (ie clinical development, CMC, supply chain, & human health ), and balancing needs of patients & ensuring stable supply of product.… 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 ... and leads technical team in preparation of submission documents; authors regulatory documents where necessary with supervision. Health Authority Interactions:… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The ... Program Management and Execution Excellence. We are looking for a season Program manager with a passion for driving impactful business outcomes for our company. This… more
- Genmab (NJ)
- …regulatory requirements.RequirementsBachelor's degree in a scientific, technical, or health -related field; advanced degree (MS, PhD) preferred.Minimum of 10 years ... and industry data standards (eg, CDISC/CDASH).Excellent cross-functional communication and project management skills.Experience supporting regulatory filings and… more
- Merck & Co. (Rahway, NJ)
- …to discover and develop innovative medicines that change the course of human health . In the RaDS value team, the Product organization is responsible for implementing ... more productive and enable innovation.We are seeking a motivated and talented Product Manager to join the RaDS Product organization. The position will report to… more
- Eisai, Inc (Nutley, NJ)
- …and drug development plans within the clinical development. Works with the clinical, project management, and data manager teams on strategic designs of studies; ... related statistical activities. 10%6. Leads and oversees preparations of inputs for regulatory documents and meetings with health authorities. Leads preparation… more
- Genmab (NJ)
- …in data analysis and interpretation to inform strategic decision making, project management, developing study delivery strategies and tactical operational plans ... aligned to the commercial and regulatory objectives.Excellent stakeholder management, concise written communication, ability to influence, clearly communicate and… more
- Novo Nordisk Inc. (Durham, NC)
- …commercial product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, etc.) required Experience with regulatory ... All employees enjoy generous paid time off including 14 paid holidays Health Insurance, Dental Insurance, Vision Insurance - effective day one Guaranteed 8%… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …36 Paid days off including vacation, sick days & company holidays Health Insurance, Dental Insurance, Vision Insurance Guaranteed 8% 401K contribution plus ... West Lebanon, NH bioproduction facility. Relationships Reports to: Automation Manager Number of subordinates with direct/indirect referral: None Essential Functions… more
- Novo Nordisk Inc. (Durham, NC)
- …All employees enjoy generous paid time off including 14 paid holidays Health Insurance, Dental Insurance, Vision Insurance - effective day one Guaranteed 8% ... equipment for the core processes to meet all customer, business & regulatory requirements through the following activities: People Focus, Process Focus, Equipment… more
- Novo Nordisk Inc. (Durham, NC)
- …All employees enjoy generous paid time off including 14 paid holidays Health Insurance, Dental Insurance, Vision Insurance - effective day one Guaranteed 8% ... of science & risk-based validation. The incumbent will provide input to project team members through all stages of specification setting, supplier selection, &… more
- Leica Biosystems (Miami, FL)
- …finished products to ensure that product specifications and company and regulatory requirements are met. Investigates and troubleshoots functionality and performance ... on-site equipment and tools calibration.This position reports to the Manager , Quality Assurance and is part of the Quality...Assurance and is part of the Quality Assurance and Regulatory Compliance Department located in Richmond, Illinois and will… more
- Cytiva (Miami, FL)
- …equipment on the customer site.This position reports to the Qualification Content Engineering Manager and is part of the Qualification Service team located at the ... to custom requirements and manage delivery on time to project /customer deadlines.Ensure high quality and continuous improvement to content...Part 11, GAMP 5, Annex 11, GxP, and other regulatory standards. Minimum of 4 years of experience in… more
- Food and Drug Administration (Silver Spring, MD)
- …Administration and other agencies. Requirements Conditions of Employment Qualifications The position of Regulatory Health Project Manager falls under the ... in the Center for Tobacco Products (CTP), Office of Science (OS), Division of Regulatory Project Management (DRPM), located in Silver Spring, Maryland, White Oak… more
- Liberty Utilities (Londonderry, NH)
- Project Manager , East Region Regulatory Londonderry, NH, US, 03053Londonderry, NH, US, 03053 **Our purpose is sustaining energy and water for life, and it is ... Department. Projects include multi-year complex, rate case, audit, and other high profile regulatory projects. The Project Manager will oversee and drive… more
- Abbott (St. Paul, MN)
- …catheters and software, vessel closure devices and peripheral stents. **The Opportunity** This ** Regulatory Affairs Project Manager ** position is an onsite ... Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the...Division. As an individual contributor, the function of a Regulatory Affairs Project Manager is… more
- Abbott (Sylmar, CA)
- …of device and Cardiac Rythm Management solutions The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our Cardiac Rythm Management ... of. + Free medical coverage for employees* via the Health Investment Plan (HIP) PPO + An excellent retirement...CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is… more
- Novant Health (Wilmington, NC)
- Job Summary Project Management - Data Analysis, Reports, and Presentations: Concurrently implements multiple Accreditation & Clinical Regulatory projects. ... EducatorServes as educator for policy and procedure processes for Novant Health . Provides support for the coordination and consolidation of corporate medical… more
