- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... and obtain shortest time to approval by global regulatory agencies.Reports to Associate Vice President, Executive Director , or Senior Director in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(GRL Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, ... with other therapeutic area leaders and joint Alliance partners.Responsibilities:Lead a multidisciplinary Global Regulatory Team (GRT) to develop global … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Senior Director ( Sr . Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset ... to optimize product labeling and obtain shortest time to approval by global regulatory agencies.You will independently manage projects, functioning as the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Global RD and PV QA organizational strategy in collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy and ... Operations. In collaboration with the Associate Director Global Strategy and Operations...team lists and track projectsProvide Strategy Operations support for regulatory inspection related activities as required such as ensuring… more
- Merck & Co. (Rahway, NJ)
- …Description of Position- This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). ... Switzerland, Canada, Japan, Australia and BrazilStay abreast of evolving global regulatory landscapes for medical device and...analysis of data for management review. Reports to - Director Regulatory Compliance, Device Quality and … more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the benefit of patients and global human health. Responsibilities :Supervises a group of statisticians in Late Development Statistics.Provides biostatistical and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...team and serves as ad hoc member to the Global Project Team for late stage projects. This position… more
- Merck & Co. (Rahway, NJ)
- …Molecule Global Science, Engineering, & Commercialization (SM GSEC) The Director , DCT Leadership position in the Manufacturing Division is a dedicated full-time ... risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen… more
- Merck & Co. (Rahway, NJ)
- …with talented and dedicated colleagues while developing and expanding your career.The Senior Director ( Sr . Principal Scientist) has primary responsibility ... Job DescriptionOur Company is a global health care leader with a diversified portfolio...monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre-clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...of the project. The CMC Lead will support the Sr . CMC Lead on complex and/or late-stage project or… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare.Our company is seeking a highly motivated candidate for the position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare. The Biologics and Biopharmaceutics team is responsible for the research… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …accordance with 21CFR part 58 (Good Laboratory Practice (GLP), and other global regulatory authority requirements, and industry best practices.Ensure /support ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… more
- Merck & Co. (Rahway, NJ)
- …needs for Finance by leveraging data analytics and understanding implications on global healthcare systems. Audit assignments are unique to each individual's skill ... will allow individuals to gain knowledge on products, healthcare systems, payors, and regulatory and reputational risks while working intimately with our global … more
- Teva Pharmaceuticals (Parsippany, NJ)
- Sr Director , Global Regulatory Medical...a difference with. **The opportunity** The Senior Director in Global Regulatory Medical ... marketing to meet the company's global strategic, scientific, regulatory , and commercial goals. The Senior Director will also: + offer clear leadership… more
- Merck (Rahway, NJ)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... product labeling and obtain shortest time to approval by global regulatory agencies. + Reports to Associate... agencies. + Reports to Associate Vice President, Executive Director , or Senior Director in… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …(GRL Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, ... area leaders and joint Alliance partners. **Responsibilities:** + Lead a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory … more
