- Merck & Co. (Rahway, NJ)
- …and solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory ... Job DescriptionOur Regulatory Affairs team bring new medical...activities include, but are not limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area… more
- Merck & Co. (Rahway, NJ)
- …communications with staff, colleagues across CMC development, Quality Assurance, and CMC Regulatory Affairs as needed to ensure understanding of needs, proper ... and vaccines from discovery through development and commercial launch.The Executive Director reports to the Associate Vice President, Analytical Enabling… 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)
- …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)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experienceExperience with ex-US ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… 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
- 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)
- …escalates performance issues and training-needs to CRA (Clinical Research Associate ) manager and/or functional vendor and internal management as-needed.Performs ... as needed different challenges and issues to TA Head/CRD Clinical Research Director /CCQM Country Clinical Quality Manager and or CTT Clinical Trial Team-(as… more
- Merck (Rahway, NJ)
- **Job Description** **Position Description:** ** Associate Director , Regulatory Affairs Liaison- Vaccines and Infectious Disease** The Regulatory ... the Vaccine and Infectious Disease (VID) therapeutic area as part of a regulatory team. They will have excellent communication and collaboration skills and will work… 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
- Merck (Rahway, NJ)
- …and solutions to the world. **Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:** + Developing ... **Job Description** Our Regulatory Affairs team bring new medical...but are not limited to:** + Reports to Executive Director or Associate Vice President, Therapeutic Area… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …of patients with life-threatening diseases. We have an exciting opportunity within US Medical Affairs for an Associate Director in our Patient Access and ... Director , Strategy Lead of PAQ Virology. The Associate Director of Medical Affairs ...the US healthcare landscape. + Solid working knowledge of regulatory and compliance environment. + Effective organizational, project planning,… 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
- 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
- Merck (Rahway, NJ)
- **Job Description** **Role Summary** + The Associate Director , Medical Operations, Innovation and Emerging Projects (AD, IEP) is a role within Global Medical and ... Value Capabilities (GMVC) in Global Medical and Scientific Affairs (GMSA) that reports directly to the Director , Medical Operations, Innovation and Emerging… more
- Sanofi Group (Morristown, NJ)
- ** Associate Director , Quality - US Consumer Healthcare (CHC)** + **Location: Morristown, NJ** + **Remote Work: Hybrid** + **Travel Expected: Limited** + **Job ... of the Regulatory Authorities, in coordination with CHC US Regulatory Affairs , lead/co-lead the support of Health Authorities in their inspections of foreign… 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