- 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
- 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** The Quantitative Pharmacology and Pharmacometrics… 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
- Danaher Corporation (New York, NY)
- …will be a part of the Global Key Account Team and report to the Sr. Director , Global Key Accounts. In this role, you will have the opportunity to: + Drive ... At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining… 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
- 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