- Insmed Incorporated (San Diego, CA)
- …to help prepare for inspections is required.Experience developing SOPs, reviewing internal clinical , regulatory and medical processes to ensure they are ... and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance… more
- Merck & Co. (North Wales, PA)
- …and key strategic engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage ... SummaryThis position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof.- In this position, you will have the… more
- Merck & Co. (Rahway, NJ)
- …tactical/scientific mentorship to other clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and ICH) ... - This position leads the scientific -pl anning and execution of one or more clinical trials or significant aspects thereof . In this position, you will have the… more
- Merck & Co. (Rahway, NJ)
- …organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full… more
- Merck & Co. (Rahway, NJ)
- …for clinical supplies . - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...(GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full c ompany's Research… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Merck & Co. (Rahway, NJ)
- …to ensure full integration of the device development activities with the clinical , regulatory , formulation, commercial and other key company functions.Lead the ... high-quality products, test methods, and robust manufacturing processes for both clinical and commercial use. This position interacts extensively with subject-matter… more
- Merck & Co. (Rahway, NJ)
- …drug/vaccine projects under supervision in Late Development Statistics. --Interacts with Clinical , Regulatory , Statistical Programming, Data Management and other ... these analyses.Prepares oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or… more
- Merck & Co. (North Wales, PA)
- …design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase ... scientific principles and statistical methods applied to designing and analyzing clinical trials in support of worldwide regulatory submissions.This position… more
- Merck & Co. (North Wales, PA)
- …managing any study specific partners and/or vendors.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage ... DescriptionThis position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have… more
- Merck & Co. (Rahway, NJ)
- …General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …strategic partnerships, and effective pipeline management. Must possess deep knowledge of pre- clinical research processes and the regulatory landscape, as well ... OverviewAs an integral part of the Lovelace Leadership Team, the Pre- Clinical Business Development Officer will lead the Institute's strategic growth initiatives by… more
- Merck & Co. (North Wales, PA)
- …and key strategic engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability ... the strategy and leads the operational planning and execution of one or more clinical trials. In this position, you will have the opportunity to demonstrate your… more
- Genmab (NJ)
- …Medical Writing Manager to help us tell the story of our science through compelling clinical and regulatory documents. You'll be at the heart of a team that ... Global Medical Writing team, you will drive the development of high-quality clinical documents to support operational, medical, and regulatory activities across… more
- Merck & Co. (South San Francisco, CA)
- …strategies and interact with various stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the ... development.Deep understanding of scientific concepts, clinical development processes, clinical testing guidelines, and the regulatory requirements for… more
- Merck & Co. (North Wales, PA)
- …and barriers to reimbursement and market access, and provides input into clinical , regulatory , payer/access, marketing and evidence generation strategies and ... resource utilization and costs, physician and patient satisfaction surveys, clinical and patient- reported outcomes assessments, systematic reviews and… more
- Merck & Co. (Rahway, NJ)
- …and barriers to reimbursement and market access, and provide input into clinical , regulatory , payer/access, marketing and evidence generation strategy and ... resource utilization and costs, physician and patient satisfaction surveys, clinical and patient reported outcomes assessments, systematic reviews and meta-analyses,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance included regulatory document reviewMust have at ... years proficiency in ICH GCP Guidelines, US and European regulatory requirements for the conduct of clinical ...European regulatory requirements for the conduct of clinical trials and creation of regulatory submission… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
