- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... rare diseases and immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic… more
- Merck & Co. (North Wales, PA)
- …divisions Office of Promotion and Advertising Review(OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and submissions ... regulations, corporate standards and policies and business objectives.Actively participate in labeling and global regulatory team meetings to ensure support for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... to Health Authority)- Participant and voting member in the labeling development process in the Labeling Working...in the labeling development process in the Labeling Working Team (LWT), in collaboration with the CDL-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... including but not limited to clinical trial management system, drug labeling , and learning management system.Administration of enterprise job scheduler, Manage File… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …fellowship is intended to provide experience for Doctors of Pharmacy within the pharmaceutical industry with a focus on Regulatory Affairs for prescription drugs and ... the skills needed to pursue a career within the pharmaceutical industry where their education and experience can make...of submissions to FDA.Assist in review or development of labeling for marketed products and new products as assigned.Assist… more
- Eisai, Inc (Los Angeles, CA)
- …and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong ... needs and educate around Eisai Oncology products consistent with FDA-approved labeling ;Employ in-person tactics to execute against account plans, including visiting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... with research laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... price reporting. Supervise external outside counsel.- Serve as a member of Labeling and Pricing Committees and as legal representative on the promotional materials… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ... CollaborationLegend Biotech USA Inc. and Janssen Biotech, Inc., one of the pharmaceutical companies of Johnson & Johnson, have entered into a global, strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... responses to Health Authority)Participant and voting member in the labeling development process in the Labeling Working...in the labeling development process in the Labeling Working Team (LWT), in collaboration with the CDLContributes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... review and sign off responsibilities for clinical trial SOPs and product labeling . Responsible for ensuring departmental compliance to all laws, rules, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to provide an educational and practical experience for a PharmD within the pharmaceutical industry. The fellow will contribute to different functional areas at Novo ... the skills needed to pursue a career within the pharmaceutical industry where their education and experience can make...medical accuracy, as well as consistency with the FDA-approved labeling . Assist the Promotional Review Board (PRB) team to… more
- Novo Nordisk Inc. (Durham, NC)
- …for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our ... weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products Tuition Assistance Life & Disability Insurance Employee Referral Awards… more
- Merck & Co. (North Wales, PA)
- …to align customer needs and Company products in accordance with product labeling .-This is achieved by keeping apprised of professional and health care environment ... professional sales, experience in marketing, military, or healthcare/scientific field ( pharmaceutical , biotech, or medical devices).- Required Experience and Skills:-… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …for all aspects of completing documentation in support of and producing pharmaceutical products following cGMP regulatory standards, SOP's to ensure the product is ... requisitions Prepares and completes checklists and packing lists Prepares labeling associated with shipments Ensures shipments meet customer requirements, shipping… more
- Friends (Boston, MA)
- …immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Labeling is a key leadership role in the PDT R&D organization accountable ... for providing guidance and oversight for the global labeling function.How You Will ContributeAccountable for oversight for Takeda's Plasma-Derived Therapies… more
- Takeda Pharmaceutical (Boston, MA)
- …immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Labeling is a key leadership role in the PDT R&D organization accountable ... for providing guidance and oversight for the global labeling function. How you will contribute: Accountable for oversight...(MSc, PhD, or PharmD) a plus. 10+ years of pharmaceutical industry experience. This is inclusive of 8 years… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ... including but not limited to, advanced multi-parameter flow-cytometry, cell labeling , mixed lymphocyte reactions, cell proliferation assays, cytotoxicity assays,… more
- Pulmovant (New York, NY)
- …authorities to support clinical trials, registration, maintenance of registration, and labeling of pharmaceutical products. Liaise with health authorities as ... needed. Contribute to the development of competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. Communicate project updates and risks to senior regulatory affairs management and stakeholders across… more
