- 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 ... you ready to make a difference? The Position The Specialist, Regulatory Operations - Submissions supports the development of submission plans created for regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include delivering high-performing teams across designated therapeutic areas that lead to best-in-class field teams and defining capabilities and frameworks ... for patient support field teams. This role will oversee program operations , compliance, vendor contracts and relationship management. AD will drive collaboration and… 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 ... difference? The Position This position is responsible for managing the day-to-day operations of Patient Safey & Technical Complaints Contact Center. This role… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …company initiatives and functions such as Marketing, IT, Clinical , Research, Operations , Patient Support Programs, and Digital Health Lead cross functional ... Share specialized knowledge and insights to enhance the team's overall capabilities Lead by example in demonstrating best practices and ethical standards in legal… 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 ... Director is a key Leadership Team member and advisor on Patient Safety Operations including handling of all safety case processing activities for adverse events… 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 ... responsible for overseeing the initial evaluation of technical complaints for US Operations (USO) post-marketed products from all the sources. This role is crucial… 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 ... oversight of Vendors and management of ICSR Verification teams, ensuring efficient operations for case processing and assessment. Serves as expert regarding case… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …entire Market Access & Public Affairs Team, PCOR (Pricing, Contracting, Operations and Reimbursement), HEOR, Marketing, Commercial Sales, Medical Affairs, and Legal ... of the activities described below Drive Formulary Placement For NNI Products Independent lead within NNI to develop RFP response for the targeted customers, manages… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …interacts with senior leaders across all areas of Novo Nordisk US Operations (USO), including USO President/Executive Office, Commercial, Market Access and Public ... Affairs, Legal, Finance and Investor Relations, Clinical , Medical and Regulatory, plus other cross functional teams...response strategy and public responses Serves as Media Relations lead for USO Crisis Response Teams (CRTs), as required… more
- Merck & Co. (Rahway, NJ)
- …Good Laboratory Practice (GLP) studies. The Associate Principal Scientist is the primary clinical study team leader and has overall responsibility for a study. ... Clinical Research, Clinical Sciences, Clinical Site Management, Clinical Study Design, Clinical Trials Operations , Computer Science, Design,… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, ... - Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical... supply planning and incorporate them into the team's operations . Focus on Customers & Patients. Make rapid, disciplined… more
- Formation Bio (New York, NY)
- …medical input into our Business Development product assessment strategy and execution, lead the development of the Clinical Development Strategy and Plans, ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Merck & Co. (Rahway, NJ)
- …depth and breadth of scientific, technical, and operational experience to lead and support facility operations , process development activities, compliance ... drive overall success of the pilot plant. The Facility Lead position reports to the Director of Operations.... Track-record of independent problem-solving. Preferred Experience and Skills: Operations experience in a GMP clinical supply… more
- Merck & Co. (Rahway, NJ)
- …to the Sr. Director of Device Product Assessment & Innovation (DPAI), the Director, Lead of Strategy for Device Product Assessment & Innovation will define and build ... strategic roadmaps to manage governance, operations , and cross-functional processes that drive efficient, discovery facing innovations and decision-making strategy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …properly trained, following process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset Lead ) is fully informed of the overall ... The Director can be an extension to the Asset Lead when needed and serve as an SME (Subject...will include providing innovative strategies to continuously improve Global Clinical Operations quality and metrics. IT will… more
- Merck & Co. (Rahway, NJ)
- …microbiology team is seeking a Director for the Rahway NJ GMP microbiology operations .- The primary objective of the position is to oversee GMP environmental ... and microbiological release of pipeline products.- The director will provide guidance, lead activities, and strengthen a team of microbiologists whose roles include… more
- Formation Bio (New York, NY)
- …how drugs and biologics are developed. We are acquiring and developing a portfolio of clinical -stage assets and looking for an IP leader who shares our vision ... but will include extensive cross functional work with business, operations , and clinical /CMC teams and could grow...Us? Impact: Shape IP strategy as our senior legal leader for a portfolio of clinical assets… more
- Merck & Co. (Rahway, NJ)
- …with other teams within BPD and staff in Process Cell Science, US Operations , Clinical Manufacturing, and Commercial Manufacturing groups. The candidate should ... team in Rahway, New Jersey, is seeking an experienced leader who will manage a team of scientists to...with superior product quality and allow speedy progression for clinical studies and commercial launch. The candidate will be… more
- Formation Bio (New York, NY)
- …with a history of effectively collaborating with senior scientific, medical, and operations staff. Demonstrated ability to lead and motivate cross-functional ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceuticals, Biopharmaceutics, Business Acumen, Business Development, Business Operations , Business Opportunities, Clinical Diagnostics, Companion ... with our company, demonstrating our ethics and values in every interaction. Lead deep scientific due diligence, ensuring the integration of internal subject matter… more
