- Actalent (Santa Monica, CA)
- … clinical trial personnel, Clinical Operations, Data Management, Clinical Development, Medical Affairs , Regulatory Affairs , Technical ... pertaining to the cell journey * Contributing member of Clinical Trial study teams * Drives the...systems to place relevant orders * Works cross-functionally with Technical Operations, Manufacturing, Quality and other depts to facilitate… more
- Amazon (Sunnyvale, CA)
- …and Echo Frames. Working as part of the Medical Devices Operational Compliance Team, the Clinical Trials Program Manager will be working to build a best in class ... products. The ideal candidate will have experience building a clinical trial operational strategy and supporting documents from scratch, including developing,… more
- University of Pennsylvania (Philadelphia, PA)
- …and wellness programs and resources, and much more. Posted Job Title Senior Clinical Trial Project Manager (Center for Cellular Immunotherapy) Job Profile Title ... products from the bench to bedside. * Manage/accelerate the clinical trial development and new study activation...FDA regulations and GCP-ICH guidelines; and comprehensive understanding of clinical trials processes and the conduct of… more
- Rush University Medical Center (Chicago, IL)
- …activities. Responsible for managing, reconciling and invoicing all revenue secured by Clinical Trials Research Revenue Cycle, work closely with operations, ... requirements specific to Research Billing. * Maintain a detailed understanding of Medicare's Clinical Trial Policy (NCD 310.1) and related guidance documents. *… more
- AbbVie (Mettawa, IL)
- …+ Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred. + May ... access. Collaborates with clinical development on Medical Affairs support of priority trials . Responsibilities +...clinical trial methodology, regulatory requirements governing clinical trials and experience in the design… more
- AbbVie (Mettawa, IL)
- …academic qualification is warranted. Expert knowledge in oncology. + Typically, 7 years of clinical trial or medical affairs experience in the pharmaceutical ... a complex medical affairs team(s) independently. + Extensive knowledge of clinical trial methodology, regulatory requirements governing clinical … more
- AbbVie (Mettawa, IL)
- …knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of ... different products. + Participation in design and execution of clinical trial safety, product safety and risk... clinical studies. + Oversees the conduct of clinical trials and is medically and scientifically… more
- Vanderbilt University Medical Center (Nashville, TN)
- …preeminent programs in patient care, education, and research. **Organization:** VICC - Clinical Trials 40 **Job Summary:** The Assistant Director supervises a ... actions, eg, hiring, promotion and termination. Required Qualifications: * Direct Clinical trial budgeting experience * Oncology experience * Understanding… more
- AbbVie (Mettawa, IL)
- …or medical affairs team(s) independently with little supervision. Knowledge of clinical trial methodology, regulatory requirements governing clinical ... strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical...industry or equivalent + Minimum of 2 years of clinical trial or medical affairs … more
- ThermoFisher Scientific (Greenville, NC)
- …global regulatory strategies on assigned (Phase 1 to 4) clinical trials , studies and projects and providing the technical / project leadership across ... compliant deliverables + Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial … more
- AbbVie (Mettawa, IL)
- …in Medical Affairs highly preferred. + Minimum of 4 years of clinical trials direct management experience in the pharmaceutical industry or academia or ... equivalent is preferred. + Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials … more
- University of Colorado (Aurora, CO)
- …that may involve industry-sponsored Phase I, II, III, IV clinical trials and investigator-initiated studies. The Regulatory Affairs Coordinator will ensure ... that may involve industry-sponsored Phase I, II, III, IV clinical trials and investigator-initiated studies. The Regulatory Affairs Coordinator will ensure… more
- Abbott (Princeton, NJ)
- … affairs /project management experience. + Knowledge and experience in working with clinical trials and managing research studies + Knowledge and understanding ... to 25% of the time to meet investigators and clinical trial staff. **Preferred Qualifications** + Advanced...degree (Masters or PhD or MD) + Experience running clinical trials in international geographies **Learn more… more
- AbbVie (Mettawa, IL)
- …. Experience with clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred. + ... our portfolio approach with a unified 'One Immunology' mindset across our medical affairs team. This role is integral to our efforts in creating and implementing… more
- ICON Clinical Research (Farmingdale, NY)
- …we are dedicated exclusively to central laboratory testing and associated services for clinical trials . We are seeking a skilled and experienced Senior ... a key role in delivering consistent and high-quality scientific support for global clinical studies. Overview: As a Senior Scientific Affairs Specialist, you… more
- AbbVie (Mettawa, IL)
- …and supports training on MI materials. + Participation in design and execution of clinical trial safety, product safety and risk management plans. + Mentors and ... medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions (patients,… more
- Merck (North Wales, PA)
- …closely with US RDMAs and others in GMSA TAs, US Health Systems, Global Clinical Development (GCD), Global Clinical Trial Operations (GCTO), Global Medical ... + The Executive Director for Cardiovascular & Metabolism (ED CVM) within US Medical Affairs (USMA) will lead the USMA field medical (FM) teams supporting CVM and… more
- Medtronic (Mounds View, MN)
- …desired + Experience in pharma, biotech and or/medical devices + Statistical or clinical trial experience + Demonstrated success in effective interpersonal and ... degree is required with a minimum of 7 years of integrated evidence-based medical affairs strategic plan experience, in a clinical or therapeutic environment +… more
- Stryker (Fremont, CA)
- …research, export, and commercial distribution, such as: IDE, IDES, IDE Progress Report, Clinical Trial Submission [OUS], 510(k), PMA, PMA Annual Report, HDE, HDE ... apply? Here are 10 reasons to join our Regulatory Affairs /Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory- affairs -team We are proud… more
- Randstad US (Chicago, IL)
- …example, orphan drug applications, Health Authority advice (EMA and FDA), paediatric plans, clinical trial designs and HA feedback. The assessment will include ... global regulatory affairs strategist. + chicago , illinois (remote) +...diligence team, with personal responsibility to provide strategic and technical regulatory guidance to the diligence team for external… more