- 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
- 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)
- …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 CDL- Contributes from a medical strategy standpoint to developing the Clinical Study Report (CSR). May review tables, listings, and figures (TLF) and CSR safety narratives- May lead the development and updates of the Investigator's… 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 for Takeda's Plasma-Derived Therapies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including but not limited to clinical trial management system, drug labeling , and learning management system.Administration of enterprise job scheduler, Manage File ... including but not limited to clinical trial management system, drug labeling , and learning management system.Support Daiichi Sankyo internal business departments,… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on preparation of submissions to FDA.Assist in review or development of labeling for marketed products and new products as assigned.Assist with technical preparation ... of how prescription drug clinical studies, regulatory strategy, and FDA-approved labeling affect promotion and advertising.Maintain up-to-date knowledge of key laws,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with research laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard ... problems of some complexity. This position makes decisions with consultation. Responsibilities:Planning for Development : Manages multiple CMC development projects. Leads submission teams with supervision. Acts as point of contact to cross-functional teams on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review and sign off responsibilities for clinical trial SOPs and product labeling . Responsible for ensuring departmental compliance to all laws, rules, and ... regulations. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)- An advanced doctorate degree (PharmD, PhD, MD, DO… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …QC label reconciliation forms independently.Responsible for managing QC sample labeling process for each batch.Knowledge and understanding of current Good ... Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems.Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)and lab management software system (LIMS)Sample Runner… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …authorship on abstracts, posters, and manuscripts, when requested Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical ... Requirements 20-30% overnight travel required. Position is Home Office Based; Ideal candidate can be based remote anywhere in the United States, ideally on the East Coast and near a major airport, yet able to travel to Plainsboro, NJ regularly. Qualifications… more
- Eisai, Inc (Los Angeles, CA)
- …needs and educate around Eisai Oncology products consistent with FDA-approved labeling ;Employ in-person tactics to execute against account plans, including visiting ... accounts to promote sales efforts, and provide clinical, efficacy and safety information on Eisai Oncology brands to key treatment decision makers/executive teams within these high control accounts.When engaging in business-to-business discussions with… more
- Novo Nordisk Inc. (Durham, NC)
- …per SOPs Execute production schedule to achieve production goals Handle labeling & components correctly; transferring, counting, FIFO, returns, etc. Participate ... actively in & support event response Review & author SOPs & other documents as required Identify, report & resolve quality issues Execute &/or assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance… 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 ... 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 management with… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …requisitions Prepares and completes checklists and packing lists Prepares labeling associated with shipments Ensures shipments meet customer requirements, shipping ... conditions, and deadlines This position may be involved with the transportation and handling of hazardous wasteThe Shipping Clerk I also performs other duties as assigned. Education RequirementsHigh School diploma Requirements Must be able to read and write… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …validity and medical accuracy, as well as consistency with the FDA-approved labeling . Assist the Promotional Review Board (PRB) team to ensure all promotional ... materials (ie , consumer and HCP websites, HCP brochures, disease awareness campaigns, direct-to-consumer commercials) are accurate, fair-balanced, truthful, and non-misleading, all while helping to achieve marketing's goals. Learn the core fundamentals of… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …candidate will assist in administrative functions of study execution such as labeling collection tubes and transporting supplies to appropriate area, quality control ... review of data, coordinating sample shipment, and acting as shift or study lead. Activities as lead may include scheduling team work assignments and acting as primary point of contact for the study director for a particular shift.QualificationsRequires a high… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …including but not limited to, advanced multi-parameter flow-cytometry, cell labeling , mixed lymphocyte reactions, cell proliferation assays, cytotoxicity assays, ... cytokine release ELISA/MSD multiplex assays is highly required. Critical thinker with strong problem-solving skills.Up-to date knowledge of immunology and immunotherapy.Track record of productivity evidenced by publications or patents.Independently plan and… more
