- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... and serves as ad hoc member to the Global Project Team for late stage projects. This position manages...technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing… more
- Merck & Co. (North Wales, PA)
- …Vice President in BARDS and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership and ... skills, expertise in leading large teams in the development of novel clinical trial designs and analysis methods in oncology, experience in directing multiple… more
- Abbott (Santa Clara, CA)
- …imaging catheters and software, vessel closure devices and peripheral stents. This Regulatory Affairs Manager position is an onsite opportunity working out of ... strategy based upon regulatory changes Support pre and post approval clinical strategy and submission activities Anticipate regulatory obstacles and emerging issues… more
- Abbott (Alameda, CA)
- …As a manager , the function of an Associate Director Regulatory Affairs , APAC (Asia Pacific) is to combine knowledge of scientific, regulatory and business ... mothers, female executives, and scientists. The Opportunity This Associate Director Regulatory Affairs - APAC will work on-site at our Alameda, CA, location in… more
- Tulane University Staff (New Orleans, LA)
- The Clinical research Project Manager is responsible for the management of all aspects of clinical trial conduct at the TRIAD Center including regulatory ... as well as institutional, local, and federal requirements. The Clinical research Project Manager is... Research Associates or SoCRA) is strongly desired. *Regulatory Affairs Certification (RAC), Certified Clinical Research Coordinator… more
- Katalyst HealthCares and Life Sciences (Cambridge, MA)
- …projects, including assigned projects and back-up projects. Participate in CMC project team meetings and provide Regulatory CMC support as needed, including ... actions, information request, risk assessment and mitigation in support of clinical trial application and marketing application. Review CMC section of submission… more
- Mindlance (Raritan, NJ)
- …Highway 202 S Job Description We are searching for the best talent for a Project Manager Scientific Operations, located in Raritan, NJ. Remote worker will not be ... considered. Purpose The Scientific Operations (SciOps) Project Manager will lead project ...strong connectivity with Medical Affairs , R&D, Regulatory Affairs , and Clinical Affairs partners… more
- Axsome Therapeutics (New York, NY)
- …additional field materials, and publication enhancers. This is a key position within Medical Affairs with ample opportunity to make a real impact. This role is based ... to, the following: Work closely with key stakeholders (eg Publications, Medical Affairs , HEOR, Field Medical) to interpret complex data to develop high-quality… more
- Orca Bio (Sacramento, CA)
- …and supporting future commercial availability of our life-saving therapies. The Project Manager , Operations facilitates and leads cross-functional projects ... transfer, facility expansions, quality and compliance, and continuous improvement activities. The project manager will operate with a deep understanding of GMP… more
- Abbott (Santa Clara, CA)
- …Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Risk Management, Clinical Project Management, external CROs ... clinical strategy, the development of plans, reports and project deliverables. Interacts with regulatory agencies as needed, and...range may vary from the range posted. JOB FAMILY: Clinical Affairs / Statistics DIVISION: AVD Vascular… more
- Syneos Health Careers (Morrisville, NC)
- Description Clinical Trial Manager - Real World Late Phase Syneos Health(R) is a leading fully integrated biopharmaceutical solutions organization built to ... accelerate customer success. We translate unique clinical , medical affairs and commercial insights into outcomes to address modern market realities. Our … more
- Abbott (Alameda, CA)
- … data listings for completeness and accuracy, and escalate issues to the Clinical Operations Manager as needed* Participate in cross-functional clinical ... and to be flexible when priorities change. Working knowledge of GCP, Clinical and Regulatory Affairs . Proficient with Microsoft Suite. Travel Requirements… more
- The University of Pennsylvania (Philadelphia, PA)
- …and resources, and much more. Posted Job Title Accountant C (Office of Clinical Research) Job Profile Title Accountant C Job Description Summary The Accountant C ... is an integral member of the Office of Clinical Research (OCR) in the Perelman School of Medicine...OCR. Under the direction of the Director and the Manager of Research Operations, the Accountant C will: *Review… more
- Zenas BioPharma (Waltham, MA)
- …equivalent) in life sciences preferred Minimum 3 years of experience in Medical Affairs , Project Management, or Operations within a biotech, pharmaceutical, or ... and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and… more
- Veterans Health Administration (Philadelphia, PA)
- …located within the Warehouse area of the Logistics Service in the Veterans Affairs Health Care System performing work that involves handling and/or overseeing one or ... May serve as a senior member of a warehouse project team; Performs other related duties as assigned. Work...program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP) Participation in the Coronavirus… more
- Veterans Health Administration (Ann Arbor, MI)
- …is located within Environmental Management Services (EMS) of a Department of Veterans Affairs VAMC. The primary purpose of this position is to exercise technical and ... routine and non-routine duties on a daily and a project -by- project basis. Non-routine duties require that the...program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP) Qualifications To qualify for… more
- Cleerly (Denver, CO)
- …management, with hands-on experience launching AI-driven healthcare solutions, or clinical SaaS. Experience leading cross-functional project teams including ... are a growing team of world-class engineering, operations, medical affairs , marketing, and sales leaders. We raised $223M in...a decade of performing some of the world's largest clinical trials to identify important findings beyond symptoms that… more
- University of Kansas Medical Center (Kansas City, KS)
- …reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager , as required. Participate in quality assurance activities by ... (CFR, GCP, HIPAA). Experience with statutes and guidelines relevant to regulatory affairs in clinical research. Experience study budgets, contracts, and grant… more
- Illumina, Inc. (San Diego, CA)
- …become more than you ever thought possible. Oncology WGS/MRD Staff Product Manager , Oncology Summary: Responsible for managing Illumina's WGS and MRD applications. ... gaps, opportunities and trends, and competitive landscape Defines business cases and project proposals for new product features Works with Commercial stakeholders to… more
- International SOS Government Medical Services (Boston, MA)
- …prevention, offering real-time, actionable insights and on-the-ground quality delivery. We provide clinical services to include "hands on" direct care at over 800 ... sites around the world, many of which include inpatient clinical care capabilities. With 12,000 staff (including 5,200 medical and behavioral health providers) our… more
