- 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 the RA ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… more
- Taiho Oncology (FL)
- …care practitioners on Taiho products and relevant disease states, and facilitation of clinical research. The Sr. Manager , Medical Field integrates clinical ... known as Medical Science Liaison Position Summary: The Sr. Manager , Medical Field is a field-facing representative of the...Medical Field is a field-facing representative of the Medical Affairs Department with a primary responsibility to engage in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, ... rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global...will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs .Facilitate operational meetings ... and marketed products; required4 or More Years Knowledge of Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP) required4 or More… more
- Merck & Co. (Minneapolis, MN)
- …that align with customer needs and business prioritiesPartner with Regional Sales Manager to develop and execute effective business strategy to reach and exceed ... organizational priorities for lasting successMeet with key opinion leaders in both clinical and university settings to discuss our Company's Animal Health portfolio… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products...NNI, a self-starter who is self-led and keeps their manager up to date on progress and ensures no… 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 ... in leading large teams in the development of novel clinical trial designs and analysis methods in oncology, experience...and maintaining high performing teams both as a direct manager and a second line manager (ie,… more
- Acadia Pharmaceuticals Inc. (San Diego, CA)
- …States and Canada for the treatment of Rett syndrome. Our clinical -stage development efforts are focused on Prader-Willi syndrome, Alzheimer's disease psychosis, ... per week. Position Summary This position will support Government Affairs and Patient Advocacy leadership teams to develop reports...will be responsible for transitioning to a new Government Affairs and Patient Advocacy database to meet new privacy… more
- Fred Hutchinson Cancer Center (Seattle, WA)
- …regarding patient consent. Serve as liaison for internal regulatory bodies (IRB, Clinical Research Support, Regulatory Affairs , etc.). Stay abreast of new ... or law strongly desired. PREFERRED QUALIFICATIONS: Master's degree in regulatory affairs . Certified IRB Professional (CIP) certification. Previous clinical … more
- BioSpace (Tarrytown, NY)
- Job Details The Senior Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with ... typically carrying out the responsibilities with minimal guidance from the Regulatory Affairs , Advertising and Promotion Director. The Senior Manager Regulatory … more
- Glycomine (Boston, MA)
- …the quality of life for patients, caregivers, and families. Job Description The Senior Clinical Project Manager / Clinical Project Manager is a team-player ... and indications through all phases of clinical trials (Phase I-III). The Senior Clinical Project Manager / Clinical Project Manager is a role in… more
- Veterans Health Administration (Chesapeake, VA)
- …Past/Current/Upcoming VHA HPT Graduates are welcome to apply. Videos Duties The clinical pharmacist position location at Hampton VA Medical Center- Western Branch ... of all aspects of the Pharmacy Service operation. The primary function of a clinical pharmacist is to assure the safe and appropriate use of medications and be… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …and leadership to ensure successful operational execution of all US Medical Clinical Research including, Medical Affairs Company Sponsored Studies (MACS) ... clinical research and program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory,… more
- Raritan Valley Community College (Somerville, NJ)
- …and, if indicated, with procedure demonstrations. Arrange and complete an orientation with the clinical site unit manager to learn the assigned clinical unit ... Part-Time, Nursing Clinical Preceptor * About Raritan Valley Community College:...Academic Chair or their designees. Effectively participate in the affairs of the College as necessary to develop and… more
- Veterans Health Administration (Portland, OR)
- …level, scope, complexity and variety of dental assisting duties representing the clinical assignment, and applies advanced clinical skills. Performs the full ... from the lead or supervisory dental assistant or the treating dentist. Clinical expanded function dental assistants perform assigned selected procedures with some… more
- Capstan (Santa Cruz, CA)
- …part 812, 50, 54, and other relevant regulations. As a vital part of the Clinical Affairs team, you will collaborate with key stakeholders to execute clinical ... a team revolutionizing heart valve treatment! Description We are seeking a Clinical Trial Manager to lead premarket clinical studies for Capstan Medical and… more
- Katalyst HealthCares and Life Sciences (Philadelphia, PA)
- …strategies. Work closely with internal and external stakeholders, including Biostatistics, Clinical Development, Quality Assurance, and Regulatory Affairs , to ... discrepancies to maintain high data standards. Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, FDA regulations, and CDISC standards. Supervise… more
- Hologic (San Diego, CA)
- …leadership by example and supports the development of a strong and engaged clinical affairs department. Recommends and implements innovative ideas for continuous ... Clinical Affair group is hiring for a Clinical Program Manager (CPM) here in San...corporate goals and objectives Excellent working knowledge of GCP, clinical affairs , and regulatory affairs … more
- Doylestown Hospital (Doylestown, PA)
- …patients' needs during an episode of care and/or post-hospitalization. All case manager activities will be client-centric, performed in a proactive manner, require ... of associated costs and education as indicated. The case manager is responsible for presenting options in an unbiased...activities with the basic goal focused on providing best clinical outcomes possible for the patient through evidenced based… 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
