- Genmab (Plainsboro, NJ)
- …throughout their lifecycle. This includes leading all major pre- and post-marketing safety related deliverables including signal, benefit- risk evaluation, and ... literature, preparing safety reports, and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …US and Canada. Overall responsible for compliance with US drug and device safety reporting regulations, Health Canada regulations ICH guidelines and the ... and participation Serves as NAO's Lead regarding FDA and Health Canada safety reporting responsibilities Directs the...respect to technical complaint handling at NNI and NNCI Risk -Based Data Insights: Responsible for the creation of KPIs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Development Safety Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to ... modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us....ensures coordination with other project deliverables Is responsible for Safety Input to all activities for Risk … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …most diverse and collaborative groups within the organization. From health -care-provider interactions and developing and implementing regulatory strategies with the ... including, but not limited to, Master Service Agreements (MSAs), Safety Data Exchange Agreements (SDEAs) and Statement of Works...to the contractual and budgetary aspects of contracting with health care systems, health care professionals and… more
- Merck & Co. (Rahway, NJ)
- …enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable ... for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering to build an integrated culture of innovation across… more
- Merck & Co. (Rahway, NJ)
- …suppliers.-- The engineer will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices ... (cGMPs), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDPs).-A high level of innovation, creativity, and… more
- Merck & Co. (North Wales, PA)
- …the Associate Director who supports the Global Regulatory Affairs & Clinical Safety (GRACS) and Quality Assurance (QA) organizations within our Research & ... to our Research & Development Division, Global Regulatory Affairs & Clinical Safety (GRACS), and QA organizations.Forecast spend related to headcount and external… more
- Merck & Co. (Durham, NC)
- …division Quality Manual or with potential for impact on product quality, patient safety or data integrity. Work closely with stakeholders and SME's from site ... objectives. Ensure the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work. Provide the independent quality… more
- Merck & Co. (Rahway, NJ)
- …and status updates to project sponsors and management.Champion compliance and safety ; promote a culture of diversity, inclusion, and equity. Minimum Education ... documentation in support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory… more
- Merck & Co. (Rahway, NJ)
- …characterization such that the process is scalable without compromising stability, safety , efficacy, and delivery. During development, we leverage smart experimental ... the right to require COVID-19 vaccinations for positions, such as in Global Employee Health , where the Company determines in its discretion that the nature of the… more
