- Merck & Co. (Rahway, NJ)
- …in project teams.Lead, develops, coordinates, and provides biostatistical support for related drug /vaccine projects in Late Development Statistics.Lead the ... trials, and in coordinating the statistical activities for clinical drug /vaccine projects.Interacts with Academic Research Organization (ARO), Contract Research… more
- Merck & Co. (Rahway, NJ)
- …teams.Develops, coordinates, and provides biostatistical leadership and support for related drug /vaccine projects in Late Development Statistics.Interacts with ... trials, and in coordinating the statistical activities for clinical drug /vaccine projects.May interact with Academic Research Organization (ARO), Contract Research… more
- Merck & Co. (North Wales, PA)
- …the Risk Management Safety Teams.- Lead and provide statistical support for related drug /vaccine projects in Clinical Safety StatisticsInteract with Safety ... Education and Minimum Requirement: PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 3 years relevant work experience, or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …partners to ensure robust development of assay, participate in HA interaction for drug - related CDx topics/questions, and attend device company HA meetings as ... (JPT) with the Diagnostic (Dx) Partner to communicate key RA updates from the drug side, as needed. Provide RA specific inputs into CDx Risk Management plans for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …5 years of industry experience preferred- 4 or More Years Extensive experience in CMC related functions including (mAb, Drug Substance, Drug Product, or New ... centered around rare diseases and immune disorders.Summary The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible… more
- Merck & Co. (Durham, NC)
- …support of Fermentation suite, Purification suite and/or Validation activities related to the vaccine drug substanceProvide technical/team support ... development and implementation of process equipment, systems and facilities related to vaccine drug substance and key...equipment, systems and facilities related to vaccine drug substance and key intermediates eg buffers, media and… more
- Aequor (New Brunswick, NJ)
- …advisor to CPD by developing and maintaining domain and functional knowledge related to drug product development. Understanding of current information technology ... Analyst for Chemical Process Development. Must Have List: BS degree in related science or technology. Advanced degree preferred. Experience with technology for data… more
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening in our Monmouth Junction, NJ facility for a Director, Drug Safety. The Director, Drug Safety is responsible for planning, directing, ... stakeholders to ensure high quality submissions are made to the Food and Drug Administration (FDA) to meet company goals. ESSENTIAL FUNCTIONS Assists and supports… more
- Insmed Incorporated (Bridgewater, NJ)
- …compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical/Clinical ... and national standards, regulations, and guidelines in partnership with Drug Safety and Pharmacovigilance (DSPV) representative. ResponsibilitiesAdditional representative responsibilities… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …be responsible for coordinating new, managing ongoing, and finalizing completed projects related to drug product processes, major equipment, and change controls ... by supporting the Project Manager(s). Job Responsibilities:Coordinate projects varying in scope (R&D, construction, equipment, etc) from inception phase to completion through the generation and tracking of timelinesAs applicable, initiate drafts with SME's,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Management processes and systems as appropriate.Strategic Planning: Contribute to or lead non- drug projects related to RD strategy. Represent Daiichi Sankyo at ... skills to clearly present options and solutions to optimize the drug development portfolio across both Oncology and Specialty Medicine.Portfolio Reporting and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needs.Guide organization on proper use of automated health care databases for drug safety- related Epidemiologic studies.Mentor junior staff in the design, ... project teams on behalf of epidemiology group. Oversee all safety related epidemiological activities Optimize epidemiological processes across regions globally, set… more
- Merck & Co. (Rahway, NJ)
- …experience OR a PhD in one of the above disciplines plus 5 years related experienceExperience with the development drug -device combination product or a medical ... company's Device Development (DD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and… more
- Taiho Oncology (TX)
- …the field. Fulfill Pharmacovigilance responsibilities as defined in the pharmacovigilance SOPs related to medical inquiries and drug safety information. Use ... may vary depending on multiple individualized factors, including market location, job- related knowledge, skills, and experience. The total compensation package for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …required/an advanced degree is strongly preferred Minimum of 10 years drug development/FDA/regulatory related industry experience required Demonstrated knowledge ... with regulatory agencies, including the FDA Experience with rare disease drug development, innovative trial design and/or expedited regulatory pathways, highly… more
- Merck & Co. (Rahway, NJ)
- …science and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global ... early to late phase pro grams with application to drug substance and a broad array of drug...tions as well as analytical technology and regulatory sciences related focus groups and consortia. - Qualifications Education Minimum… more
- Merck & Co. (North Wales, PA)
- …compounds or marketed products throughout the entire life cycle of the drug .Provides leadership to the staff by leading the Global Regulatory Team which ... FDA; prepares the teams for meetings with FDA at all phases of drug development.Leads cross-functional efforts to prepare for advisory committees and may speak at… more
- Merck & Co. (San Diego, CA)
- …company's pipeline programs encompassing early target discovery and validation, drug discovery, translational sciences, and precision medicine in collaboration with ... limited to: Working with team leaders to develop strategy and drive drug discovery, translational medicine, and precision medicine / diagnostics (Dx) discovery… more
- Merck & Co. (Rahway, NJ)
- …Quantitative Pharmacology and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to routinely enable efficient ... drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced leadership team, deep modeling expertise and… more
- Merck & Co. (South San Francisco, CA)
- …and is an integral part of our Company's powerful world-class network of drug and vaccine discovery.We are inspired by the belief that a research-driven enterprise ... and biophysical techniques along with data analysis to design and synthesize drug candidates and intermediates. The successful candidate will interface with diverse… more
