- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThe Manager, Regulatory Affairs Labeling position will provide Regulatory support for global labeling ... of the labeling leadership, the manager will develop, review and revise labeling for FDA submission, create and modify Structured Product Labeling for FDA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic ... and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This...hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Labeling Specialist supports the development of labeling activities for all regulatory ... knowledge of drug development and how it relates to labeling operations and requirements to manage the execution of...also supports the systems and processes by which regulatory labeling items are created, approved submitted and maintained for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc ... member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading the ... development and maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC...Affairs (GRA) and will report to the Sr Director, Labeling , Policy and Intelligence. The position will be based… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc ... member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for license renewals, responses to Health Authority)Participant and voting member in the labeling development process in the Labeling Working Team (LWT), in ... collaboration with the CDLContributes from a medical strategy standpoint to developing the Clinical Study Report (CSR). May review tables, listings, and figures (TLF) and CSR safety narrativesMay lead the development and updates of the Investigator's Brochure… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and completing associated documentation in support of inspecting, packaging and/or labeling pharmaceutical products in compliance with all safety policies, cGMPs, ... finishing team to perform responsibilities associated with inspection, packaging, labeling , packing, palletizing, cleaning, reconciliation, traceability, training, and/or accurate… more
- Aequor (South San Francisco, CA)
- …extended periods. Performing repetitive tasks such as cell culture, pipetting and labeling tubes. Collaboration across the Investigative Toxicology team and with key ... stakeholders. Work with potentially hazardous materials including (but not limited to): chemotherapeutics, biological hazards and human primary cells more
- Aequor (Northborough, MA)
- …group, located at the Northborough Operations Center facility, is responsible for labeling and packaging of final drug product vials as finished product for ... sale and distribution to US, European and International markets in support of a global patient population. In the process of performing these functions, Packaging interacts with and receives support from the Quality Assurance, Materials Management, Facilities… more
- Merck & Co. (North Wales, PA)
- …customer needs and our Company's vaccine attributes in accordanc e with product labeling , and CDC and professional society recommendations. - Provid ing Company ... Vaccine management with updates on customer needs as it relates to helping them improve patient health outcomes , customer feedback, marketplace dynamics, and progress towards quality goals. - Provid ing customers with key insights by k eeping apprised of… more
- Merck & Co. (TX)
- …Professionals to align customer needs and Company products in accordance with product labeling .- This is achieved by keeping apprised of professional and health care ... environment knowledge through self-study of company-provided scientific, product and marketplace information, attendance at product workshops and conferences, as well as consistent and ongoing review of Company promotional materials.Providing Company… more
- Merck & Co. (North Wales, PA)
- …& Health Literacy Investigator Studies ProgramDrive innovative patient labeling initiative to enhance product communication post-approval.Incorporate health literacy ... and SDoH into brand strategyIntegrate health literacy data into CORE SDoH database and develop data-driven approaches to identify and measure new, scalable models of SDoH/health literacyParticipate in SDoH working groups, data analytics and health equity… more
- Genmab (Plainsboro, NJ)
- …will join a highly competent global team focused on packaging and labeling clinical trial supplies, collaborating closely with the Global Clinical Drug Supply ... Planning team. Together with the Global Clinical Drug Supply Systems team, these groups form the Global Clinical Drug Supply department. We foster a supportive, international, and fast-paced work environment centered on collaboration, excellence, and a can-do… more
- Merck & Co. (Rahway, NJ)
- …techniques for characterizing ligand-protein interactions such as FPOP, photoaffinity labeling and native mass spectrometry would be a significant ... advantage.Knowledge of structural techniques such as bioNMR, x-ray crystallography and cryo-electron microscopy is beneficial.Experience with classical protein biochemistry techniques including gel electrophoresis, western blotting, enzymatic digestion,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …different disease-therapeutic areas, and associated regulatory areas including Product Labeling , Chemistry, Manufacturing and Controls, Policy and Intelligence Work ... with knowledgeable mentors and develop skills to build a strong career foundation! Work on programs and strategies for compounds in development and/or marketed products Use creative problem-solving skillsets, to develop new ideas and insights, including… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …mix-upsSupervise activities that support the inspection, packaging, labeling , packing, palletizing, cleaning, reconciliation, traceability, training, and/or ... accurate as well as timely completion of finishing batch records and production paperworkConduct employee reviews and provide coaching as appropriate; maintain performance and attendance recordsConduct shift hand-off meetings, to ensure support/continuity of… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Technician is responsible for performing QA inspection, sampling, AQL, and release labeling of raw materials to be used in production. Job Responsibilities Perform ... QA inspection of incoming raw materials prior to their use in productionPerform AQL sampling and sampling breakdown of incoming raw materials including components and Active Pharmaceutical Ingredients (API)Assist with the sampling of DEA raw materials (DEA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …price reporting. Supervise external outside counsel.- Serve as a member of Labeling and Pricing Committees and as legal representative on the promotional materials ... review team for market access team and materials (including, but not limited to, patient programs, patient support hub services, call center operations, reimbursement assistance and expanded use programs, PIE, FDAMA 114 and healthcare economics initiatives) on… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …manufacturing scale up, equipment and process qualification, packaging and labeling . This position will interface with Operations, Regulatory, Quality Assurance, ... Finance, R&D, Project Management and Quality Control departments to complete the technology transfer for customers. This position will lead, mentor and grow the Technical Service Department.Job ResponsibilitiesFunction as the customer liaison for tech transfer… more
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