- 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
- Merck & Co. (North Wales, PA)
- Job DescriptionWe are currently recruiting for the position of Associate Director , US Oncology - Hematology Scientific Strategy. This talented individual will ... Build out a robust scientific leader (SL) engagement plan, coordinating with medical affairs , clinical research, and global marketing to provide a consistent One our… more
- Merck & Co. (North Wales, PA)
- …that interface with internal and external stakeholders, including US Medical Affairs , Regional Vaccine Medical Directors, Global Marketing, the Center for ... and advocacy perspective, ensuring alignment with marketing strategy Collaborate with Medical Affairs to develop and execute upon a scientific engagement plan that… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible for developing and executing ... alignment with the Evidence Generation Plan (EGP). Externally, the Associate Director RP will be the lead...across CDSE and more broadly within Clinical, Medical and Regulatory , Market Access and Public Affairs . Externally,… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical trials is required Demonstrates technical expertise within Clinical Development, Medical Affairs , and Regulatory Affairs (CMR), staying up-to-date ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Strategy Pleasanton, CA, USA * Princeton, NJ, USA Req #374 Friday, June 28, 2024 Looking for a chance to make a ... and/or development regulatory activities under the direction of Regulatory Affairs management. The incumbent plans, directs and executes the regulatory… more
- Novo Nordisk (Princeton, NJ)
- …changing lives for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions +… more
- Bausch Health (Bridgewater, NJ)
- …your skills and values drive our collective progress and impact. The Associate Director , Advertising and Promotion, Prescription Drug Products, reviews, approves ... to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs ** + Location: Cambridge, MA or Bridgewater, NJ **About the job** ... The Associate Director , US Advertising and Promotion serves...The Associate Director , US Advertising and Promotion serves as the ... lead on Review Committees (RCs). As the RC Regulatory Affairs representative, work with brands on… more
- J&J Family of Companies (Horsham, PA)
- Associate Medical Director , Rheumatology Therapeutic Area - Medical Affairs - 2406188235W **Description** Johnson & Johnson is recruiting for an Associate ... humanity. Learn more at https://www.jnj.com/. As a member of Immunology (IMM) Medical Affairs , the Associate Medical Director , Rheumatology TA will assist… more
- J&J Family of Companies (Horsham, PA)
- Associate Director , Clinical Scientist- Gastroenterology Therapeutic Area - Medical Affairs - 2406185119W **Description** Johnson & Johnson is currently ... seeking an Associate Director , Clinical Scientist to join our...Director , Clinical Scientist to join our world-class Medical Affairs Gastroenterology Therapeutic Area Strategy Team located in Horsham,… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …company that will inspire you and empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic Planning - GI2 ... TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs)… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Device Regulatory Lead ( Associate Director )** + Location: Bridgewater, NJ or Swiftwater, PA or Cambridge, MA **About the job** The Global ... Regulatory Affairs Device team is a globally...Regulatory Affairs Device team is a globally diverse team supporting...of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and… more
