- Teva Pharmaceuticals (Parsippany, NJ)
- Sr Director , Global Regulatory Medical Writing & Data Transparency Date: Nov 29, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva ... to make a difference with. **The opportunity** The Senior Director in Global Regulatory Medical...offices **Your experience and qualifications** + PhD in life sciences (or other related field) with a minimum of… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director , Therapy Area Head, Global Regulatory Medical Writing (USA, Remote) Date: Dec 16, 2024 Location: Parsippany, United States, New Jersey, 07005 ... to live better, healthier lives. **The opportunity** As a ** Director , in Global Regulatory Medical...experience and qualifications** + PhD or PharmD in life sciences (or other related field) with a minimum of… more
- Bristol Myers Squibb (Summit, NJ)
- …through all stages of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key stakeholders to execute ... and Health Authorities. Develop & communicate strategic direction based on global regulatory guidelines and experience. **Position Responsibilities** In addition… 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 ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of... global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT… 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 ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may… 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Clinical Sciences , Hematology, leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and ... development. The Director reports to the Senior Director Clinical Sciences and collaborates closely with...Clinical Scientist; Member of the Clinical Study Team and Global Clinical SubTeam + Line Manager for CS team… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …knowledge of current global and regional trends in medical writing and regulatory and is able to apply this to advance and accelerate medical writing strategies ... management and contributes strategic, expert input into scientific and regulatory content that is used for a variety of...writer to join our dynamic team at the Associate Director level. You will author a wide range of… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …quantitative pharmacology approaches for clinical pharmacology decision-making and for global regulatory submissions, including INDs, IBs, NDAs, BLAs, ... aspirations. Join Gilead and help create possible, together. **Job Description** ** Director , Pharmacometrics** **_*This is a site-based position in Foster City, CA… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …statistical analysis and reporting of Gilead clinical data in efficiently achieving regulatory , scientific and business objectives. The Associate Director will ... Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …preparation, conduct and follow-up for GCP, GLP/GCLP and GPV inspections by regulatory health authorities. You will typically represent Gilead in regulatory ... inspections as a lead representative and point-of-contact for regulatory agencies. You will collaborate cross-functionally to ensure Gilead's ongoing regulatory … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** Gilead Sciences , Inc. is a research-based biopharmaceutical company founded in 1987. Together ... leads to identify clear and scientifically appropriate ways to communicate Gilead Science data + Collaborate effectively with leading Viral Hepatitis /Liver Disease… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** **Senior Director , Integrated Supply Planning** This position is responsible for developing and ... the company and the various governmental agencies. Directly interfaces with regulatory agencies as required. + Coordinates interdepartmental activity with Quality… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …medical review, ensure the MR process and procedure in alignment with regulatory requirements, and provide strategic medical input to Strategic Operations as well ... MR strategies, processes, standards, practices, efficiencies, and capabilities to meet regulatory requirements and beyond. This includes the process and strategy for… more
- Bristol Myers Squibb (Summit, NJ)
- …through the testing and release process. + Supports clinical and commercial global regulatory filings and authors/ reviews/approves portions of the filings ... strategy and standards related to analytics. + Direct experience managing interactions with global regulatory agencies and in the preparation of regulatory … 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 ... + Ensure global development plans will meet global regulatory requirements by soliciting and integrating...single vision as inspiring as Transforming patients' lives through science (TM) , every BMS employee plays an integral… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director , Translational Science Lead - Immunology (Parsippany, NJ or West Chester, PA) Date: Nov 30, 2024 Location: Parsippany, United States, New Jersey, 07005 ... you a pioneering scientist ready to drive innovation in immunology? Teva's R&D Global Early Clinical Development is expanding and seeks a passionate **Translational … 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 ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi… more
- Sanofi Group (Bridgewater, NJ)
- …of patients around the world. **Medical Director ** **- Global Medical Evidence Generation** supports disease registries, post- regulatory authorization ... **Job Title:** Medical Director - Global Medical Evidence Generation...needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a… 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 ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi… more