- 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 PharmacometricsT he (remote) position is only applicable for those that are not within… more
- Merck & Co. (Rahway, NJ)
- …Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You ... will spearhead regulatory activities for Devices and Drug-Device Combinations (DDDC), ensuring...fostering a collaborative environment Maintain in depth knowledge of global device and drug/biologic-device combination product guidelines and policy… more
- Merck & Co. (Rahway, NJ)
- …Animal Health Sites.Leads site EHS leaders and influences site, region, and global business partners to drive prioritization of regulatory compliance, continuous ... Job DescriptionOur Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and… more
- Merck & Co. (Rahway, NJ)
- …needsEnsure an exquisite partnership with Global Clinical Trial Operations, Regulatory and other Development Sciences and Clinical Supply (DSCS) groups, ... AuditsCo-Chair of USA and EMEA Cross Divisional Trade and Regulatory CouncilsResponsible for Global Warehousing/Logistics/Transportation/VAT Expenditures for… 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 project delivery.A complete understanding of ICH GCP and Global /Regional/Local regulatory requirements is-required.-Strong Communication skills requiring ... Job DescriptionThe Clinical Research Director (CRD) is the Clinical Operations lead in...scope for GCTO country operations.Adherence to GCP, local and global policies and procedures to conduct high-quality, inspection ready-studies… 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)
- …Small Molecule Science and Technology (SM S&T) within our Manufacturing Division's Global Science and Engineering Commercialization.- SM S&T aims to be an ... Job DescriptionWe are seeking a visionary Executive Director to lead our End-to-End Technical Leader organization and join the leadership team of… 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, ... 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
- Merck & Co. (Rahway, NJ)
- …endpoints including proportional hazards models. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in ... - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global...Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs),… more
- Merck & Co. (Rahway, NJ)
- …cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. -- Specifically, the Director may ... Job DescriptionOur company is a global health care leader with a diversified portfolio...small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious… more
- Merck & Co. (Rahway, NJ)
- …continued R&D and drive access to life-saving medicines for patients? If so, the Director , Biologics Patent Attorney role , at our Company could be an ideal ... areas of the business including discovery, development, manufacturing, and supply, regulatory , business development, commercial groups, and other legal functions . -… more
- 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 ... 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
- Danaher Corporation (Port Washington, NY)
- …Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. Director Global Quality and Regulatory ... REQUIRED with a preferred relevant engineering major, Quality related field or material science fields with 15 years of progressive Regulatory compliance and /… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director , Therapy Area Head, Global Regulatory Medical Writing (USA, Remote) Date: Jan 14, 2025 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
- Edgewell Personal Care (Allendale, NJ)
- …Edgewell's values and behaviors. **Accountabilities** + Responsible for leading Edgewell's Global Regulatory organization. + Demonstrate strong business acumen, ... **Required Education, Skills and Experience** + Bachelor's degree in Regulatory , Law, Science or related field. +...Registration Processes and NAFTA is desired. + Knowledge of global regulatory framework for consumer safety and… 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
