- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT)… more
- Genmab (Princeton, NJ)
- …The Role The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group ... within Regulatory Affairs (RA) to ensure timely and high-quality document...implementation of submission templates, establish governance board responsible for global authoring templates and global dossier submission… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director , Regulatory Operations - Dossier Planning is ... INDs, original and supplemental NDAs/BLAs/MAAs. The Associate Director partners with the Head of Regulatory ...will allow for seamless submission planning processes from a Global perspective. The Associate Director … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg ... plans), including HA engagement plans and mitigation strategies.Ensure high quality collaboration global regulatory leads and provides guidance to the regional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Eisai, Inc (Nutley, NJ)
- …role.#LI-MI1 #IND123 #LI-Remote Eisai Salary Transparency Language:The base salary range for the Associate Director , Global RWE (Real World Evidence), ... profile, we want to hear from you. Summary The Associate Director is responsible for developing RWE...cross-functional teams including US medical affairs, marketing, market access global value and access teams, commercial to align strategies… more
- Merck & Co. (Rahway, NJ)
- …the organization in 2023.We are seeking a leader to take the position of the Associate Director Global Marketing, who will be responsible for maximization of ... of post-surgical infections and ensuring successful outcomes. Antibiotics are crucial for global public health.Our Company has a proud legacy of nearly 100 years… more
- Merck & Co. (Durham, NC)
- …world with our core principle of Safety First and Quality Always.The Associate Director , Engineering/Maintenance will support a new drug substance manufacturing ... Purification unit operations and associated clean utilities and process equipment.- The Associate Director will manage tactical and strategic process, equipment,… more
- Merck & Co. (North Wales, PA)
- …the Research & Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug ... Job DescriptionThe drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in...& Development pipeline and realize its full potential. The Associate Director is expected to provide project… more
- Insmed Incorporated (San Diego, CA)
- …to the Executive Director of Program Management, the Associate Director , Program Management supports the cross-functional drug development ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...in accordance with the program strategy. In addition, the Associate Director of PM may be asked… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Director US Oncology Marketing Digital Engagement will direct the identification, design, execution, oversight, and optimization of ... environment or scrum frameworkMarket research knowledgeKnowledge of our commercial, regulatory , and legal compliance policiesEnd-to-end medical/legal (PRT) review and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... value from inception through to implementation. Demonstrates ability to handle global projects through established interactions with Japan and Europe as required.… more
- Merck & Co. (Rahway, NJ)
- …planning, warehouse operations, distribution, ensuring compliance with market requirements as global regulatory requirements continue to evolve. Develops subject ... will be responsible for delivering SAP solutions to our Research Organizations' Global Clinical and Ancillary Supply-user community. You will p articipate in… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description Associate Director , Automation The Associate Director Manufacturing Automation is responsible for managing the team ... supply of product and on time project executionProviding direct support for regulatory inspections and audits and other validation activities by serving as the… more
- Merck & Co. (North Wales, PA)
- …stakeholders, including US Medical Affairs, Regional Vaccine Medical Directors, Global Marketing, the Center for Observational and Real-World Evidence (CORE), ... review processes) including experience including bringing materials through legal, regulatory , and clinical review Strong project management skills as demonstrated… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for… 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 ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...serve as G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team and G-RA… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Represent Device Development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the ... and enforcement of data standards, demonstrated knowledge of industry standards related regulatory requirements (CDISC), FDA & ICH, PMDA, EU & ICH, CRP and… more
- Merck & Co. (North Wales, PA)
- …cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be ... statistics, and manufacturing to manage clinical development projects; andAssist the Senior Director , Executive Director , and/or Associate Vice President in… more
