- Merck & Co. (North Wales, PA)
- …developmental compounds or marketed products throughout the entire life cycle of the drug .Provides leadership as head of the Global Regulatory Team, which ... Job DescriptionThe Regulatory Affairs Headquarters Principal Scientist is responsible for...teams for meetings with FDA at all phases of drug development.Leads cross-functional efforts to prepare for advisory committees… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance ... our pipeline and drive our strategic priorities.The Director , Principal Scientist - Regulatory Affairs Liaison...teams for meetings with FDA at any phase of drug development. Lead cross-functional efforts to prepare for advisory… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... and external to GRACS. Key Functions Reports to Executive Director or Associate Vice President, General MedicineWorks Independently and...MS with a minimum of 10 years of relevant drug development experience with majority in regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as ... preferred Minimum of 8 years total pharmaceutical/related industry experience in drug development required Demonstrated knowledge of global regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry required.8 or More Years in regulatory affairsExperience in providing regulatory strategic input into the drug development process with thorough ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Merck & Co. (Rahway, NJ)
- …team is responsible for the research and development of sterile & parenteral drug products for biologics as well as the biopharmaceutics support for the oral ... and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that… more
- Merck & Co. (Rahway, NJ)
- …chemical and biochemical processes, parenteral, oral, and specialty dosage formulations.- The director should be well engaged with regulatory and industry trends ... R&D and DSCS. --The candidate will have experience in an innovative analytical/ regulatory /GMP environment.The Director will effectively team with the SMAR&D… more
- Merck & Co. (Boston, MA)
- …internal and external staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global ... physician-scientist to join our group as a- Principal Scientist (Clinical Director ) in Translational Medicine/Early Clinical Development in the Cardiovascular and… more
- Merck & Co. (Rahway, NJ)
- …strategic thinking skills and an eagerness to learn scientific processes, drug discovery and development processes, regulatory requirements as necessary ... other RaDS architecture and engineering team members.Ensure ongoing compliance with regulatory safety, Good Practice (GxP) and Validation requirements when required.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Director , Clinical Scientist This position drives scientific planning, strategy and execution of Phase 1-4 clinical ... trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the… more
- Tris Pharma (Monmouth Junction, NJ)
- …(FDA) guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director / Director , AR&D serves ... Associate Director / Director , Analytical Research and DevelopmentMonmouth Junction,...projects. The incumbent ensures thorough characterization of formulations and drug delivery technologies under development and builds in-house analytical… more
- Merck & Co. (Rahway, NJ)
- …and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, and ... company is seeking a highly motivated candidate for the position of Director , Small Molecule Development within the Mixed Modalities, Sterile Product Development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liaisons to ensure successful implementation of CDx and data ... collectionSupports Regulatory affairs in providing content and providing review of...assay technologies such as NGS, IHC, PCR etc.Knowledge of drug development process and an understanding of how diagnostic… more
- Merck & Co. (Rahway, NJ)
- … drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within ... with ability to understand how MIDD can drive portfolio and regulatory decisionsDeep knowledge of drug development, pharmacokinetics and pharmacology… more
- Merck & Co. (Rahway, NJ)
- …Molecule Analytical Research and Development (SMAR&D) group has an exciting opportunity for a Director role as GxP Strategic Lead based in Rahway, NJ. Join us and ... science, and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global… 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 ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …drug substance manufacture, and authoring of relevant sections of regulatory filingsExperience in excipient, drug product intermediates, formulation ... for physical characterization and crystallization of complex molecules and drug products involving synthetic peptides, oligonucleotides, drug -linkers in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Clinical Development Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and management to drive strategies and activities for early and late phase drug development candidates within the team to support overall CMC development plan.- ... Represent CMC development project teams on cross-functional drug development project teams with a predominately operational focus; ensuring to establish good working… more
