- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global ... Salary Transparency Language:The base salary range for the Executive Director , Global Regulatory Affairs -...the employment eligibility of all new hires in the United States . Please click on the following… 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 ... Leads US FDA/EU EMA interactions with support from higher-level manager. Regulatory Knowledge: Demonstrates expert knowledge of US /EU regulatory … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to regulatory agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs . Develop and maintain positive rapport ... and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...documents such as cover letters, pre-meeting package, and other US specific regulatory positioning documents to assist… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is ... SM) and relevant external stakeholders. The role will manage and or support medical affairs Quality resources ( US , Brazil, Japan/ APAC and EU):in an efficient… more
- Novo Nordisk Inc. (WA)
- …your potential? This role can sit in Plainsboro, NJ or Washington, DC. The Position The Director - US Tax, Trade, IP works on complex issues that will require an ... locally and globally. Relationships Reports to the Market Access and Public Affairs Senior Director , Policy. Other internal relationships include a dotted… more
- Eisai, Inc (Raleigh, NC)
- …or site manufacturing changes in collaboration with Product Quality, Regulatory Affairs , and Technical Operations.Establish productive business relationships ... experiences with the Finance, commercial Sales and Marketing organizations, regulatory affairs , and with third party manufacturers.Strong...the employment eligibility of all new hires in the United States . Please click on the following… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Expert understanding of the pharmaceutical industry including marketing, medical, access, public affairs , compliance, legal and regulatory as well as the ... direction of Novo Nordisk Inc. (NNI)/North America Operations (NAO) and leads all US commercial efforts for Novo Nordisk's Rare Disease portfolio. The mandate of… more
- Merck & Co. (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Expert understanding of the pharmaceutical industry including marketing, medical, access, public affairs , compliance, legal and regulatory as well as the ... direction of Novo Nordisk Inc. (NNI)/North America Operations (NAO) and leads all US commercial efforts for Novo Nordisk's Rare Disease portfolio. The mandate of… more
- Genmab (NJ)
- …Management, Clinical Operations, Medical, Biomarker Management, Biostatistics, Medical Writing, and Regulatory Affairs to ensure alignment of data strategy with ... fit? Then we would love to have you join us !The RoleThe Associate Director , External Data Quality...deviations and is a key driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , and other relevant NNI departments to ensure alignment ... 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 The Director , Consumer Marketing,… more
- Merck & Co. (Rahway, NJ)
- …the guidance of a senior leader, a Senior Principal Scientist/Senior Director , has primary responsibility for developing value evidence strategies, and ... responsibilities also include development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …through human-centered design pull you in? Are you ready to experiment with us ? The Position The Senior Director Commercial Innovation drives commercial ... behaviors. Our 'test and learn' mindset and approach enables us to iterate rapidly and refine our strategies based...team culture that is made up of diverse skillsets, united by the shared belief that reinvention and learning… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other functional teams in NNI (including MAPA), including marketing, medical, R&D, regulatory affairs , finance, NNGlobal, and other relevant entities to develop ... 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 The Director Channel Strategy… more
- Genmab (NJ)
- …inspire you and feel like a fit? Then we would love to have you join us !The Role & DepartmentThe Feasibility Lead supports the vision and strategy set forth by the ... with key stakeholders within Global Development Operations (GDO), Medical Affairs , Medical, and/or CROs, to enable expedited, predictive delivery for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …market access and public affairs (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders to ... behaviors. Our 'test and learn' mindset and approach enables us to iterate rapidly and refine our strategies based...team culture that is made up of diverse skillsets, united by the shared belief that reinvention and learning… more
- Novo Nordisk Inc. (San Francisco, CA)
- 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
- Ascendis Pharma (Palo Alto, CA)
- …. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director , Regulatory Affairs will serve as the therapeutic area head ... as well as Life Cycle Management Strategies. The Sr. Director will work closely with the executive team to...Management, and Leadership teams to develop and implement the US and global regulatory affairs … more
- AbbVie (North Chicago, IL)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Regulatory Affairs Chemistry, Manufacturing and Controls ... marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research &… more
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