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- Charlotte, NC
new job!

We are looking for a Senior Regulatory Affairs Manager who will play a primary and integral role in the regulatory activities and initiatives at the facility. Incumbent will guide US regulatory strategies across multiple programs at this emerging facility, lead pre and post-approval submission activities, and serve as regulatory lead to interdisciplinary cross-functional groups across entire product life cycles. Key Responsibilities:Coordinate ANDA submissions to FDA, interact with regulatory....

- Gaithersburg, MD
new job!

Director of Clinical Development Cardio This global Pharmaceutical company is the worldwide biologics research and development leader. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Director, Clinical Development in Gaithersburg MD or Cambridge UK, you’ll play a pivotal role in....

We are looking for a Quality Assurance Validation Technician who will provide Quality Assurance support for validation activities associated with equipment, processes, facilities, and computer software/systems to ensure compliance with applicable current Good Manufacturing Practice (GMP) regulations, corporate policies, and site Standard Operating Procedures (SOP). Work closely with the various departments in the design and development of validation protocols to ensure the purpose, testing and

- Any US State

Global Pharmaceutical company is hiring Clinical Project Manager for their Clinical Development studies Day to day management of studies This position is responsible for providing oversight of Phase 1 to Phase 4 clinical trial implementation; ensuring clinical studies are conducted in a timely manner with milestones being achieved within budget.Essential FunctionsThe Clinical Project Manager for this Pharmaceutical company- will:Utilize Project Management techniques and methodologies to plan,....

- Menlo Park, CA

Education and Qualifications - Pharm.D., PhD, or M.D. or equivalent education. - Preferable five to seven years clinical or clinical development experience in the biotechnology or pharmaceutical industry or a combination of academia and industry. - Participated in clinical oncology studies. Overview The Medical Director will collaborate with company management, design, plan and develop clinical evaluation research studies in hematology oncology. He / She will prepare, author and maintain....

The Senior Manager Clinical Operations is responsible for developing operational strategy for one or more clinical studies, and leading the cross functional Study Management Team to align and deliver on study goals of data quality, timelines, budget and GCP compliance in support of overall program level plans. Responsibilities: The Senior Manager Clinical Operations Lead will independently plan all aspects of the clinical operations for one or more clinical studies and oversee the execution of

- Buffalo Grove, IL

The Applications Technologist position is with a leading player in the global specialty and fine chemicals industry. This Company delivers and dedicates their practices towards the development of enhanced products and process performances with markets in biotechnology, paints and coatings, personal care, metalworking fluids, energy and other industrial markets. Being a valued part of the R&D team, this specific role for the Applications Technologist will be focused specifically on the....

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