- Teva Pharmaceuticals (Parsippany, NJ)
- Sr Director , Global Regulatory Medical Writing & Data Transparency Date: Jan 26, 2025 Location: Parsippany, United States, New Jersey, 07054 Company: Teva ... new people to make a difference with. **The opportunity** The Senior Director in Global Regulatory Medical Writing & Data Transparency provides leadership,… more
- Edgewell Personal Care (Allendale, NJ)
- …Edgewell's values and behaviors. **Accountabilities** + Responsible for leading Edgewell's Global Regulatory organization. + Demonstrate strong business acumen, ... Canadian Registration Processes and NAFTA is desired. + Knowledge of global regulatory framework for consumer safety and pharmacovigilance. + Proven ability to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary:** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... RA strategy into a global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and other governance bodies. + Serve as… more
- 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
- Insight Global (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 ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …ICH guidance for clinical documents + Participate in initiatives within the Global Regulatory Writing Group to identify process improvement opportunities, ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...around rare diseases and immune disorders. **Summary** The Associate Director of Regulatory Writing is a key… more
- Bristol Myers Squibb (Madison, NJ)
- …more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... (HA) queries. + Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and implement the preparation of all regulatory submissions and provide regulatory support across all global projects, securing the cooperation of others ... 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. (Basking Ridge, NJ)
- …Brings issues with regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution. + ... Participate in global product team meetings to provide US regulatory support and guidance as needed and manage day-to-day regulatory activities. + Continuing… 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 ... process improvements or other special projects. May initiate and/or contribute to global process improvements. + Provides regulatory guidance on new marketing… more
- Black & Veatch (Paramus, NJ)
- ** Global Benefits Director ** Date: Jan 23, 2025 Location: Overland Park, KS, US US Company: Black & Veatch Family of Companies **Together, we own our company, ... questions and put your diverse talents and perspectives to use. **The Opportunity** The ** Global Benefits Director ** will have the opportunity to: + Lead the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. **Summary** Reporting to the Senior Director , I&A, the Associate Director , Global Oncology Forecasting ... drive creation of demand and revenue forecasts. The Associate Director is a dynamic member of the Global...with Market Research, Competitive Intelligence, Marketing, MA, R&D, Finance, Regulatory and Market Access internally across global … more
- Stryker (Allendale, NJ)
- …with global and cross-functional teams is imperative. The Senior Director , Enterprise Architect will also be accountable for developing, managing, monitoring, ... Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) **Position summary:** The Senior Director , Enterprise Architecture is a people leadership role… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director , Pipeline Immunology Asset Lead, Global Health Economics, Value, and Outcomes Date: Jan 11, 2025 Location: Parsippany, United States, New Jersey, 07054 ... and new people to make a difference with. **The opportunity** As the ** Director , Pipeline Immunology Asset Lead - ImmunoOncology, GHEVO,** you'll serve as a… 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 ... feasibility and delivery. The role supports all phases of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and… more
- Teva Pharmaceuticals (Parsippany, NJ)
- … will serve as a clinical leader for INDs, NDAs, BLAs, and other global regulatory filings, while also cultivating relationships with thought leaders and ... Senior Director Clinical Development - Psychiatry Date: Jan 28,... regulatory authority discussions. + Lead interactions with global regulatory authorities, providing clinical expertise and… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …to and responsible for the clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings. **How you'll spend your day** The Sr. Director ... documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Senior Director , Clinical Development will… more
- Bristol Myers Squibb (Summit, NJ)
- …program. + Oversee due diligence, integration and/or acquisition activities. + Incorporate global regulatory trends and changes into the organization as ... personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Director of Clinical Quality Audit strategy is responsible for defining… more