- Teva Pharmaceuticals (Parsippany, NJ)
- Sr Director , Global Regulatory Medical Writing & Data Transparency Date: Dec 28, 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …regulatory activities. The Associate Director RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and ... around rare diseases and immune disorders. **Summary:** The Associate Director , Regulatory Affairs - Regulatory ...and drives coordination of global and US … 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
- Merck (Rahway, NJ)
- …coaching/guidance to individual contributors + Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... **Job Description** **R5 -** ** Director - Pharmacometrics,** **Quantitative Pharmacology and Pharmacometrics** _T_ _he (remote) position is only applicable for those… 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)
- …We are seeking a strong, experienced Clinical Operations leader for a Director position within our Oncology Group. Clinical Operations is responsible for the ... trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports … 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)
- …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
- JPMorgan Chase (Jersey City, NJ)
- …pillars such as financial crimes, trade surveillance, legal, audit, resiliency, regulatory management, etc. We work closely with business stakeholders and partners ... business pain points and improving efficiency and effectiveness. As an Applied AI ML Director , you will lead a team of data scientists at the forefront of innovation… 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Medical Science MSES, will be primarily responsible for creating ... and in creating and implementing experimental medicine studies. Reporting into the Senior Director of the Medical Science Early-Stage, the Director , MSES… 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, ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of...around rare diseases and immune disorders. **Summary** The Associate Director of Regulatory Writing is a key… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …evidence, and creating hope for all facing illness. As a senior member of Medical Science , the Senior Director , oncology group, Medical Science - Early Stage ... involving complex indications including rare disease/orphan conditions. The Senior Director , oncology group, Medical Science - Early...clinical data as required for senior management on a global basis. + Support regulatory safety reporting… 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: Dec 29, 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