- Novo Nordisk Inc. (Plainsboro, NJ)
- …or a life sciences/pharmacy nursing degree with 13+ years' experience in global safety surveillance and/or clinical/ drug development Excellent verbal ... Hub portfolio in close collaboration with key stakeholders from Global Safety Surveillance and other cross functional...Safety Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management… more
- Merck & Co. (Rahway, NJ)
- …Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our company's ... Division by:Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel… more
- Merck & Co. (Rahway, NJ)
- …15 years of experience with engineering design, equipment operation, vendor interface, risk assessment, process safety and industry guidance.- Project Size is ... DescriptionThe Technical Director operates under the guidance of the Executive Director - Global Technology Center and will have responsibility for a key projects in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on… more
- Merck & Co. (Durham, NC)
- …people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in the ... local plant connected to our global manufacturing network to ensure the highest quality of...PAI, and ultimately the commercial manufacture of the product's Drug Substance.-GENERAL PROFILE Provides leadership and direction to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Senior Director position, which will have unique exposure to Daiichi Sankyo's global drug portfolio from the Research stage to post marketing/lifecycle ... is diligently considered prior to selecting promising candidates (DP0), allowing product safety leaders (PSLs) and global project teams (GPTs) to enact a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …be responsible for overall product safety strategy or specific areas of safety surveillance and risk management, and provide safety leadership including ... safety topics, and regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities for internal QA team ( global / local), and not limited to: Global Project Team, Safety Management Team, Clinical Safety and Pharmacovigilance ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- …to Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... within the General Medicine Therapeutic Area, functioning as the single, accountable, global point of contact on those projects.Functions as first liaison assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Team (SMT) materials- Supports overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...clinical sections of study-level documents (eg, protocol, amendments)- Reviews safety data to mitigate risk to trial… more
- Merck & Co. (Durham, NC)
- …therapies for our patients. We work in the manufacturing plants with a " Safety First, Quality Always" mindset, striving for continuous improvement, and earn our ... produce. We work in local plants connected to our global manufacturing network supplying the highest quality of raw...Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture… more
- Merck & Co. (Durham, NC)
- …areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety , Process Development, Technical Services, Utilities and Validation.- Position ... the site Technical Operations team supporting vaccine manufacturing operations spanning drug substance and drug product areas.- Expected outcomes… more
- Catalent (St. Petersburg, FL)
- …+ 8 Paid HolidaysCatalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over ... through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. The...Pre-Audit Preparation activities with an understanding of requesting sites risk assessment to ensure alignment to Global … 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 ... team enables the translation of preclinical candidates into non-oral drug products. Our team is looking for a strong...to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its… more
- Catalent (St. Petersburg, FL)
- …+ 8 Paid HolidaysCatalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over ... Supplier Quality Regional Lead Position Summary: Catalent is a global , high-growth, public company, and a leading partner for...through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. As… more
- Merck & Co. (Rahway, NJ)
- …phase screening platforms, and biophysical characterization to enable deep understanding of drug substances and drug products and successful advancement of small ... and Regulatory Standards: Develops and implements quality standards and specifications for drug substance and drug product when required.- Ensures the delivery… more
- Merck & Co. (Durham, NC)
- …to the patients around the world with our core principle of Safety First and Quality Always.The Associate Director, Engineering/Maintenance will support a new ... drug substance manufacturing operation's engineering, maintenance, and calibration activities.- This scope includes Sterile Supply, Fermentation, and Purification… more
- Merck & Co. (North Wales, PA)
- …marketing of medical drugs and vaccines for the benefit of patients and global human health. This position supports statistical programming activities for late stage ... drug /vaccine clinical development projects. This may include leadership of...and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the… more
- Catalent (TX)
- …& 8 paid holidaysCatalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over ... leads to achieve timely deal closure and growth expectations.Mitigates risk through understanding of proposed terms and conditions and...a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and… more
