- 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
- Merck & Co. (Rahway, NJ)
- …include, but are not limited to:Reports to Executive Director or Associate Vice President, General MedicineDevelops worldwide product regulatory strategy to ... Job DescriptionOur Regulatory Affairs team bring new medical...for someone with a growth mindset.Position Description: The Senior Director , Global Regulatory Lead, is responsible for… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Summary The Associate Director is responsible for developing RWE strategies for assigned product(s) and ... #IND123 #LI-Remote Eisai Salary Transparency Language:The base salary range for the Associate Director , Global RWE (Real World Evidence), Global Medical … 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)
- …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)
- … Liaisons to ensure successful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents ... under the direction of the GPT CDx representative while keeping abreast of regulatory and policy updates in the external environment and by tracking and… 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
- 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …to build/maintain database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for content ... participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Associate Director , Biologics will serve as the primary interface… more
- Merck (Rahway, NJ)
- **Job Description** Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, ... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and...but are not limited to:** + Reports to Executive Director or Associate Vice President, General Medicine… more
- AbbVie (Florham Park, NJ)
- …(https://www.instagram.com/abbvieireland/) , YouTube and LinkedIn. Job Description Purpose: The Associate Scientific Director provides medical and scientific ... strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions...regulatory , etc.) as they relate to on-going medical affairs projects. + May assist as consultant and liaison… 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
- 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
- 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
- AbbVie (Newark, NJ)
- …Clinical Development and Operations, Biostatistics, Regulatory Affairs , Medical Affairs , and the Commercial organization. The Director represents HEOR at ... HEOR Strategy and other functions (eg, Clinical Development & Operations, Regulatory , Commercial). The Director , Patient-Centered Outcomes Research, will support… more
