- Merck & Co. (South San Francisco, CA)
- …documents that effectively and clearly describe research results, product candidates, and other information required for regulatory submissions.Ensure ... in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent Workers apply HERE… more
- Merck & Co. (North Wales, PA)
- …colleagues from key countries and regionsServes as an impactful member of Product Development Team sub-teams ( Clinical , Value Evidence, Commercial, Publications ... Job DescriptionRole Summary:The Global Senior Director Medical Affairs (GDMA) Immunology/Pipeline & Biomarkers...key countries and regions. They are impactful members of Product Development Team sub-teams and Global Human Health commercialization… more
- Merck & Co. (Rahway, NJ)
- …execute and development of methods for release, characterization, and stability testing of clinical trial material and in support of product and process ... department of our Research & Development Division is seeking applicants for a Senior Scientist position available at our research facility. The Senior Scientist… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head's primary objectives will be ... late-stage development for our company's assets in this TA by overseeing Product Development Teams (PDTs) and collaborating with Section Heads, PDT Leaders, and… more
- Merck & Co. (Rahway, NJ)
- …our Rahway, NJ, Formulation, Laboratory, and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- ... Job DescriptionPharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for...cleaning, and processing of raw materials into finished drug product . These individuals are expected to partner with and… more
- Merck & Co. (North Wales, PA)
- …the Research & Development organization at our company. Position Description/Summary The Senior Specialist, Project Manager is a core member of Early Drug ... strategies and execute our Company's drug and vaccine development efforts. The Senior Specialist is expected to provide project management leadership and drive… more
- Catalent (San Diego, CA)
- …Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a member of the Site Leadership Team, you will partner with ... Senior Manager, Quality AssurancePosition Summary:Catalent Pharma in San...manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit… more
- Merck & Co. (Rahway, NJ)
- …and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical , Regulatory, Statistical Programming, Data Management, and our ... providing guidance to others in the statistical support for clinical drug/vaccine projects.-Interacts with Academic Research Organization (ARO), Contract Research… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Professional Services Veterinarian- Dermatology Specialist will function to support the commercial, medical, and business needs of the ... to collaborate and consult on research projects, including market support studies, clinical trials, grant programs, and pre- clinical development of productsScope… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …based on the MOA and initial toxicological profile. Provide a first, preliminary benefit/ risk assessment and make available to senior leadership at DP0. Surface ... for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as early… more
- Merck & Co. (Rahway, NJ)
- …drug/vaccine projects in Late Development Statistics.Lead the interaction with Clinical , Regulatory, Statistical Programming, Data Management, and other Company ... Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine… more
- Merck & Co. (North Wales, PA)
- …This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Merck & Co. (Rahway, NJ)
- …oversight of, contractors performing various GMP activities supporting the production of clinical supplies with focus on drug product . Additionally, experience ... expected to independently execute on the following:Plans and facilitates high risk and highly complex Quality-related process reviews and/or investigations under… more
- Merck & Co. (Rahway, NJ)
- … risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ... This position will be responsible for applying their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that… more
- Merck & Co. (Rahway, NJ)
- …HIV Long-Acting Treatment P rograms and gain a competitive advantage.Collaborate with Clinical Teams to shape the commercial HIV product profile, label, ... the joint alliance committees and in the HIV long-acting Product Development Team (PDT) and play a pivotal role...chronic disease. However, as people with HIV age, the risk of developing comorbidities increases, and they are exposed… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Business Units. Provide strategic and proactive QA Leadership for respective GPTs and Clinical Programs in close alignment with the Head of R&D QA. Within assigned ... GPTs, facilitate the implementation of a risk -based quality management process fully embedded through trial design,...Head of RD QA with Quality Reviews of respective product profile to ensure appropriate management review of all… more
- Merck & Co. (Rahway, NJ)
- …of patients on a global scale. -This role will lead an exciting pipeline product currently in Phase 2; a Factor XI anticoagulant being studied to reduce major ... events in patients with end-stage kidney disease (ESKD), with a reduced risk of bleeding vs currently available therapies.Reporting to the AVP, Metabolics and… more
- Merck & Co. (Rahway, NJ)
- …(EDSA) maximizes meaningful bi-directional scientific exchange with the worldwide clinical and academic community to positively impact Research and Development ... Failure) ensuring scientific rigor- Provides subject matter expertise for Product Development and Publications teams and facilitates cross-functional communication… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Leader in driving strategy development and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a ... Clinical Sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages the… more
