- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg integrated ... drug/diagnostic regulatory and submission plans), including HA engagement plans and...engagement plans and mitigation strategies.Ensure high quality collaboration global regulatory leads and provides guidance to the regional strategists… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing ... Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations through internal technical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Liasions to ensure sucessful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents ... globallyCreates a forward-looking Diagnostic development strategy while keeping abreast of regulatory and policy updates in the external environment and by tracking… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities ... and is also an integral member of the Medical Affairs Team. This position plays a key role in...data and promotional content within the assigned therapeutic area- Regulatory milestones, actions and guidance relevant to medical review… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global PV Quality teams located in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …statistical results and provide input on reporting (CSR) to support Medical Affairs and HEOR/HTA strategies: Plan, set-up and execute additional statistical analyses ... Statistical deliverables. Contribute, with limited supervision, to documents submitted to Regulatory or Pricing Authorities. May participate as subject matter expert… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will ... mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... + Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience authoring and/or implementing processes. +… more
- Cypress Creek Renewables (New York, NY)
- Associate Director , State Affairs (East) at Cypress Creek Renewables (View all jobs) (https://ccrenew.com/careers/) New York or East Coast Remote The Company ... progress of our infrastructure development by driv ing new legislative and regulatory policies , expand relationships with key stakeholders , develop strategies that… more
- Bristol Myers Squibb (Madison, NJ)
- …MS or commensurate experience preferred **Experience Requirements** Significant experience in regulatory affairs (eg 3-5 years) **Key Competency Requirements** ... careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products in development and through life… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Associate Director , New Product Strategy - Parsippany, NJ Date: Jun 11, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals ... our in-house development and 3rd party partners. As an Associate Director , New Product Strategy your challenge...coordination with key stakeholders in Generic R&D, Operations, Legal Affairs , Regulatory Affairs , Quality Management,… more
- Veterans Affairs, Veterans Health Administration (Tarrytown, NY)
- …Experience: 3 or more years of senior nursing leadership experience at the Associate Director for Patient Care Services/Chief Nurse Executive level. Experience ... to transform health care and clinical processes and, provide oversight for regulatory , licensure and accreditation requirements related to all aspects of nursing… more
- Mercy University (Dobbs Ferry, NY)
- Associate Director of International Programs Print (https://www.schooljobs.com/careers/mercyedu/jobs/newprint/3708544) Apply Associate Director of ... Union Status Non-Union + Description + Benefits Job Posting Summary The Associate Director of International Programs will provide management and oversight… more
- Intra-Cellular Therapies, Inc (New York, NY)
- …is expanding our Marketing Team to support access to CAPLYTA, and we seek an Associate Director of Access Marketing and Regional Pull-through to join our team! ... aimed at ensuring successful market access, reimbursement, and customer engagement. The Associate Director of Access Marketing and Regional Pull-through will… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and become your best self. Become a **maker of possible** with us. **Job Overview:** The Associate Director , ISC Cost to Win Leader IS/CC is a critical member of ... the IS/CC Platform team. Reporting to the Sr Director , ISC CTW Cost Improvement, he/she will work closely...and peers in Procurement, BD Excellence, Supply Chain, Quality, Regulatory , R&D, Finance, HR, Med Affairs , Marketing,… more
- Bristol Myers Squibb (Summit, NJ)
- …than here at BMS with our Cell Therapy team. **Position Summary** The Associate Director - Cell Therapy Sales, Operations, & Mid/Long-Term Supply Planning is ... role includes both Commercial & Clinical phase assets and/or priorities. The Associate Director will collaborate heavily with inter-department colleagues as well… more
- AbbVie (Florham Park, NJ)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Migraine Consumer Marketing serves as the patient, brand ... objectives and goals. . Work with internal cross functional groups (Public Affairs , Professional Marketing, Legal, Regulatory , Medical and Project Management) to… more
