Lead clinical pharmacology activities related to study design, protocol development, study execution, reporting and interpretation of data. Conduct PK and PK/PD analysis . Work closely with pharmacometrics team members and provides input related to analysis and reporting of PK and PK/PD. Lead development of clinical pharmacology sections for regulatory filings including a

The Thought Leader Liaison (TLL) is responsible for developing, managing, and engaging with Key Opinion Leaders throughout their assigned geography reporting to the Thought Leader Liaison Lead, reporting through Specialty Brands Marketing. He/she works closely with commercial colleagues and other staff to help build advocacy of Mallinckrodt's products with KOLs. TheThough

Manage Regulatory Affairs, Advertising & Promotion and Compliance Group Manage the US RA Ad Promo, submission operations, labeling and compliance group staff, including objective setting and career development activities and motivate line reports to achieve shared and individual goals. Regulatory Leadership of Advertising and Promotional Materials Serve as subject matter

The Clinical Trial Documentation Specialist position is based within our Clinical Operations group, and works with departmental management and the Principal Investigator in the implementation of project clinical trial protocols. Job Type Full Time Base Hours 9 00AM 6 00PM Monday through Friday MINIMUM QUALIFICATION REQUIREMENTS To perform this job, an individual must be a

Under general supervision, assist in the performance of laboratory research and procedures by performing a variety of routine experimental techniques such as electrophoresis, centrifugation, chromatography, and the like. Collect, verify, record, and compile data and information in support of research. Essential Duties and Responsibilities (Specific duties will depend on n

The Thought Leader Liaison (TLL) is responsible for developing, managing, and engaging with Key Opinion Leaders throughout their assigned geography reporting to the Thought Leader Liaison Lead, reporting through Specialty Brands Marketing. He/she works closely with commercial colleagues and other staff to help build advocacy of Mallinckrodt's products with KOLs. TheThough

/ Accountabilities The purpose of this position is to serve as an Analytical Quality Assurance (AQA) Associate. This role will report to the Section Head of Analytical QA or other senior leaders in the Quality organization at InvaGen Pharmaceuticals, Inc. This role will be part of the Cipla NY (Invagen) Quality Control (QC)/Analytical QA Team whose role is to ensure our pa

BioMed Tech I Facility PHS Bio Medical Services Location US NJ Denville ID 2024 160868 Category Non Clinical Tech Position Type Full Time Shift Days Job Type Non Exempt Overview Join our team of dedicated professionals who provide services and operational support to award winning hospitals through roles in supply chain, IT and cybersecurity, clinical engineering, capital

The Senior Manager, Regulatory Affairs position will support the Regulatory Affairs (RA) Director to help define the regulatory strategy for our innovative next generation technology for cellular therapy. This position will play a substantial role researching regulations, defining and implementing the regulatory strategy and engaging with health authorities to effectively

DETAILS This position develops, documents and executes pre market and post market clinical evidence strategies for medical devices across product platforms. Works with cross functional teams and key stakeholders to execute on clinical evidence strategies for specific products/product families. For established products in the EU market, writes post market clinical follow up

Manager, Regulatory Affairs North America (Hybrid) It's an exciting time to be part of IFF's Global Regulatory Affairs. This hybrid role requires presence in the office minimum of 1 day/week in the Holmdel, NJ location. As the Manager of Regulatory Affairs, you will be responsible for the regulatory compliance and conformity to customer requirements for fragrance products

Do you have what it takes a competitive drive coupled with exceptional sales ability. In this role, you'll be autonomous in your own territory promoting tablets for one of the largest, leading generics companies in the world. The selected professional will be an integral part of a nationwide sales team developing and managing an assigned territory. You will Maximize new b

The Thought Leader Liaison (TLL) is responsible for developing, managing, and engaging with Key Opinion Leaders throughout their assigned geography reporting to the Thought Leader Liaison Lead, reporting through Specialty Brands Marketing. He/she works closely with commercial colleagues and other staff to help build advocacy of Mallinckrodt's products with KOLs. TheThough

R esponsibilities for the Software Quality , Lead position include Identify and manage cross functional process improvement projects across the Quality Assurance organization ; Manage CAPA and deviation identification, tracking, follow up, and closure; E valuate and approve proposed changes of GxP and non GxP systems prior to implementation ; R eview and a pprove system r

Nestle Nutrition R&D Centers, Inc. seeks a Principal Scientist in Holbrook NY Duties Proactively identify consumer centric packaging technologies and strategies to solve or enable knowledge discovery involving sustainability, recycling, product, or other challenges. Partner internally and externally to determine new packaging solutions. Develop discovery from bench to man