The Technology & Data Solutions (TDS) business unit is the Syneos Health accelerator for life sciences innovation. TDS houses our advanced technology acquisitions, homegrown products & applications, actively participates in new M&A and partnership activities, delivers critical insights as part of our integrated strategy for customers and drives enterprise wide adoption an

US Regulatory TA Strategy Lead the development and execution of US regulatory strategy in conjunction with Global Regulatory Lead (GRL), Global Regulatory Team and Global project teams. Partner with the GRL to understand the competitive landscape, e.g., views of US HAs, regulatory precedents, labeling differences and TA specific issues. Utilize US regulatory expertise and

Raw material testing including Establishing R&D raw material specifications within LIMS Analytical testing support. Scheduling and Ensuring laboratory equipment is maintained and calibrations performed Supporting and /or conducting investigations. Accurately interpret and document test results. Writing analytical test methods, method development reports, method validation

US Regulatory TA Strategy Develop and execute US regulatory strategy, with oversight as needed, and in conjunction with Global Regulatory Lead (GRL), Global Regulatory Team and Global project teams. Partner with the GRL to understand the competitive landscape, e.g., views of US HAs, regulatory precedents, labeling differences and TA specific issues. Utilize US regulatory

Prepares medication orders by compounding or admixing medications under supervision of a registered pharmacist. Checks all orders for completeness of information. Verifies patient information and proper physician authorization. Checks all orders for insurance approval before admixing. Under a professional's supervision, admixes drugs as ordered by physician in an accurate

The Clinical Scientist supports clinical development programs by actively participating in, and/or leading when appropriate, aspects of the development, oversight and execution of phase I to IV clinical research trials. Collaborating closely with Physicians, Clinical Leaders and other scientific colleagues, the incumbent contributes to the design, data collection and repo

This position is accountable for supporting Pharmacy clinical management. The responsibilities include assisting in formulary management, medication therapy management, utilization management, research and collaboration with disease management and medical management. Responsibilities Supports the pharmacy formulary management program, medication therapy management program

Supports client projects through early translational to late development for clinical pharmacology and quantitative analyses Collaborates with internal and client teams on regulatory, clinical development, clinical, pharmacology, pharmacometric and another drug development issues Assist Project Leaders in writing and compiling reports and other documents summarizing advic

At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Validation Engineer/Specialist to join our talented team at our office located in Somerset, New Jersey . In this role, you will perform cGMP compliance based services (commissioning, qualificat

Who we are Silk Road Medical, Inc. is a medical device company located in Sunnyvale, California & Plymouth, MN, that is focused on reducing the risk of stroke and has pioneered a new approach for the treatment of carotid artery disease called TransCarotid Artery Revascularization (TCAR). We are always looking for dynamic and innovative individuals who are passionate about

Job Type Full Time. Base Hours 8 30AM – 5 00PM Monday through Friday MINIMUM QUALIFICATION REQUIREMENTS To perform this job, an individual must be able to perform each essential duty satisfactorily, and meet the educational and experience requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES Microbial Limits testing and validation Preservative Efficacy testing Water t

Pharmacy Technician Per Diem Summit Oaks Hospital Summit, NJ As a per diem, nonexempt CPS Solutions, LLC Pharmacy Technician at Summit Oaks Hospital,you will assist in various pharmacy activities under the supervision of a licensed pharmacist. Your responsibilities will include preparing, delivering, and restocking medications; performing order entry; procuring drugs; bil

Company Description Join us and make YOUR mark on the World! Are you interested in joining some of the brightest talent in the world to strengthen the United States' security? Come join Lawrence Livermore National Laboratory (LLNL) where our employees apply their expertise to create solutions for BIG ideas that make our world a better place. We are committed to a diverse a

Responsibilities Essential Duties Adheres to all policies and procedures Prepares compounded sterile products using aseptic technique and CAPS Standard Operating Procedures. Ensures pharmacy compliance with rules and regulations of the State Board of Pharmacy and other regulating agencies. Reviews orders and prescriptions for admixing and dispensing. Resolves order discre

include, but are not limited to Develop relationships with healthcare professionals and provide them with credible, fair and balanced scientific information about Idorsia and its products, research activities, and Idorsia product development while understanding their perspectives, including challenges when treating patients. Liaises with key internal stakeholders to build