- Merck & Co. (Rahway, NJ)
- …day-to-day coaching/guidance to individual contributorsMaintaining a comprehensive understanding of global regulatory expectations for small molecules and ... Job DescriptionR5 - Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsThe Quantitative Pharmacology and Pharmacometrics (QP2) department… 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
- Merck & Co. (Rahway, NJ)
- …and other pharmacometric analyses-Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… more
- Merck & Co. (Rahway, NJ)
- …Clinical Supply and Technology Innovation implementation into the pipeline.The Director Manufacturing Operations (m/f/d) leads an Operating Unit responsible for ... continuous manufacturing -with a Quality First, Safety Aways Mindset. -The Director Manufacturing Operations (m/f/d) leads teams responsible for Technology Transfer,… more
- Merck & Co. (Rahway, NJ)
- …and materials characterization tools and techniquesExtensive knowledge of technical and global regulatory requirements for medical devices and combination ... Job DescriptionThe Senior Director of Device Product Stewardship will lead a...product portfolio.-3. Collaborate with cross-functional partners, including R&D, Quality, Regulatory , Manufacturing, Technical Product Leaders, and Value Chain to… more
- Merck & Co. (Rahway, NJ)
- …modeling of tumor size and survival. A Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, ... Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Director . QP2-IO team is part of the Global...methods. Experience in IND, NDA and other submissions to global regulatory agencies. Skills in experimental design,… more
- 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- Reporting to the Senior Director , Planning & Strategy for Regulatory Affairs, Global Patient Safety, and Development Quality (RA, GPS and DQ), the ... reflective of the values of the Regeneron Way. _Key Internal Interfaces_ + Regulatory Affairs, Global Patient Safety, and Development Quality (RA, PS &… 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 (Tarrytown, NY)
- The Global Patient Safety (GPS) Lead role ( Director of GPS) serves as the first point of contact (POC) for all safety related issues for the compound(s) ... environment within and external to GPS including senior management. The GPS Director joins Regeneron's industry leading scientific organization, and has a direct… 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Medical Director of Clinical Sciences should be a qualified physician with pharmaceutical industry experience, within Ophthalmology Therapeutics Development. ... You will work closely with other members of Global Clinical Development, contributing to the creation of Clinical...creation of Clinical Development Plans (CDP) that meet international regulatory standards. Will work with the clinical team running… 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Medical Director , Clinical Sciences functions as clinical leader of a section of a clinical program (eg, an indication, a new formulation, or a specific ... development phase), under leadership of Program Lead Medical Director (Program Lead MD) or Sr. Medical Director...the section of the clinical program in partnership with global line functions, assigned Clinical Scientist and Clinical Operations… 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
