- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager /Associate Director will be ... Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy and Intelligence. The position will...Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to assist with overflow in other areas as needed. Relationships Reports to a Manager , Senior Manager , Associate Director or Director. Works with personnel ... development, CMR is involved. The one thing that keeps us all marching to the same beat is our... to compose letters incorporating NN position on external regulatory initiatives Works with Group Manager to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US /EU ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...as the company liaison with the Health Authority (eg, US FDA and EU EMA) for assigned projects with… more
- Eisai, Inc (Baltimore, MD)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... Metrology program, ensuring goals and tasks are met within. Interact with regulatory agencies as needed.Monitors and manages calibration program and technicians to… more
- Novo Nordisk Inc. (Boulder, CO)
- …dynamic professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Manager of Drug Product Manufacturing is ... and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at...Place to Live for the second consecutive year by US News & World Report, Boulder is experiencing a… more
- Aequor (Thousand Oaks, CA)
- …invite to come Schedule - flexible, normal shift Title (Role) Case Management - Senior Manager Organization Global Patient Safety Ideal candidate: BS 8&plus YOE ... Group Purpose Act as US /EU local safety office and FDA/EMA point of contact...cases in a timely manner to meet all worldwide regulatory authority requirements Provide vendors with resources and training… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to experiment with us ? The Position The purpose of the Senior Manager - Marketing Campaign Automation role is to drive the successful execution ... behaviors. Our 'test and learn' mindset and approach enables us to iterate rapidly and refine our strategies based...social media by leveraging a robust martech stack. The Senior Manager - Marketing Campaign Automation ensures… more
- Merck & Co. (North Wales, PA)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The Role & Department As a Senior Programming Associate or Programming Manager , you will be in the ... relevant therapeutic and professional areas.Maintains up-to-date knowledge on relevant regulatory guidelines/requirements.Proactively develops and maintains good working relationship with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manages the activities to process the bi-weekly and off-cycle payrolls for US and Canadian employees- Participates and preforms year-end activities to ensure ... payroll reporting processes by collaborating with various departments and regulatory agencies, analyzing their business requirements, and designing and developing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …This position requires strong collaboration with stakeholders across Clinical Medical and Regulatory (CMR), including the NACO senior leadership team and line ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of customer needs and behaviors. Our 'test and learn' mindset and approach enables us to iterate rapidly and refine our strategies based on real-world results. We ... team culture that is made up of diverse skillsets, united by the shared belief that reinvention and learning...pull you in? Are you ready to experiment with us ? The Position To provide national and regional convention… more
- Tris Pharma (Monmouth Junction, NJ)
- …Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines ... address unmet patient needs. We have more than 150 US and International patents including applications and have marketed...New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager ,… more
- Merck & Co. (Rahway, NJ)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... Job Description Job Description: - The drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Marketing, Medical Affairs) as well as DSI employees performing Global roles in the United States (such as Global Marketing, Global Medical Affairs). For these ... and the primary legal advisor for the commercial business and operations supporting US approved (or to be approved) oncology products and to specific assigned… 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...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Merck & Co. (Millsboro, DE)
- …documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections ... team of animal care and testing specialists.Serve as a member of the Senior Leadership Team for the Millsboro, DE biologics manufacturing site.Lead numerous projects… more
- Novo Nordisk Inc. (Boulder, CO)
- …API. Relationships The Technician II, API Manufacturing reports to the Senior Manager , API Manufacturing. Essential Functions Provides support for ... and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at...Place to Live for the second consecutive year by US News & World Report, Boulder is experiencing a… more
- Aequor (Thousand Oaks, CA)
- …who lives local to any site is highly preferred (ATO, ARI, AMA any US location) IDEAL CANDIDATE: The ideal candidate should have previous experience managing quality ... experience managing in Track Wise or Veeva Systems Have quality experience manager records Project management skillsThe Specialist Manufacturing is expected to own… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration.Job ... The SQE Manager , QA Compliance, is responsible for managing the...trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety, environmental and company policies Perform other… more
