- Katalyst HealthCares and Life Sciences (Newark, NJ)
- …a product(s) with multiple driver indications within a Therapeutic Area and supports the Sr. Manager Clinical Affairs in the development & execution of the ... Responsibilities: The Regulatory Affairs Manager is responsible for the...contribute to regulated communication on Regulatory/FDA issues including Public Affairs , Clinical Development, Legal, and others such… more
- Katalyst HealthCares and Life Sciences (Southern Md Facility, MD)
- …sciences or engineering, or other technical discipline. 6 years of Regulatory affairs job experience in the medical device industry. Technical or Medical Writing ... requirements for medical devices including Quality Systems standards and clinical investigations. Proficient with MS Office Suite (Word, Excel, PowerPoint,… 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
- Katalyst HealthCares and Life Sciences (Cambridge, MA)
- …actions, information request, risk assessment and mitigation in support of clinical trial application and marketing application. Review CMC section of submission ... dossiers for clinical trial application (IMPD/IND) and marketing authorization application (NDA/MAA)...trending deficiencies for improvement of CMC section to support clinical studies and marketing applications. Consult with SMD management… 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
- Veterans Health Administration (Chesapeake, VA)
- … clinical indicators, thresholds, and performance measurements. Follow Veterans Affairs Central Office (VACO) guidelines with regards to management of patients ... Summary This position is located within the Department of Veterans Affairs (VA), Veterans Health Administration (VHA), VA Mid-Atlantic Health Care Network (VISN 6),… 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 ... protocols, study timelines as well as institutional, local, and federal requirements. The Clinical research Project Manager is required to have an advanced… more
- Abbott (Santa Clara, CA)
- …Regulatory Affairs , Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Risk Management, ... as well as study sites as directed by your manager . What You'll Work On Writes clinical ...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
- Veterans Health Administration (Nashville, TN)
- …located at our Nashville campus in our Specialty Clinic. The Nurse Manager Medical Specialty Care is a designated first-line supervisory authority, responsibility, ... provide timely nursing care which complies with generally accepted standards of clinical practice. This includes the authority to accept, amend, or reject the… more
- Duke University (Durham, NC)
- …coordination for three complex well-being units in the Division of Student Affairs : Counseling & Psychological Services, Student Health, and Student Insurance. The ... functions such as financial analysis, statistical reporting, cost analysis, clinical reporting, inventory management, insurance provider relationships, clinical … more
- Mindlance (Raritan, NJ)
- …as needed. Provides strong connectivity with Medical Affairs , R&D, Regulatory Affairs , and Clinical Affairs partners and leverage capabilities from ... 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.… more
- Zenas BioPharma (Waltham, MA)
- …and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and ... Excellence and Innovation - TRUE Innovation ! Position Summary: The Senior Manager /Associate Director of Medical Operations will oversee the execution of Medical … more
- Veterans Health Administration (Philadelphia, PA)
- …influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP) Qualifications To qualify for this position, ... Under the Fair Chance to Compete Act, the Department of Veterans Affairs prohibits requesting an applicant's criminal history prior to accepting a tentative… 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 ... program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP) Participation in the Coronavirus...knowledge regarding a candidate's abilities; and assist a hiring manager with making a final selection for a position.… more
- IQVIA, Inc. (Los Angeles, CA)
- …With a focus on providing talent for field/inside sales, medical device support, clinical support, and medical affairs our CSMS division has 10,000+ field ... top notch candidates for the role of Oncology Account Manager . We are partnering to join a fast paced...strategic goals. This individual will use their highly developed clinical and business acumen along with their knowledge of… more
- Cepheid (Miami, FL)
- …Reporting globally. The role will collaborate closely with Medical and Scientific Affairs , Risk Management and Post Market Surveillance teams and you will learn ... about diagnostic therapies, clinical impacts to patients and latest Post Market Surveillance...other Quality related functions.This position reports to the Sr. Manager Regulatory Compliance and Post Market Surveillance and is… more
