- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical ... centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key... will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relationships with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs .Facilitate ... language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of… 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 ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… 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, ... three days per week. Position Summary This position will support Government Affairs and Patient Advocacy leadership teams to develop reports that communicate metrics… 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 ... strongly desired. PREFERRED QUALIFICATIONS: Master's degree in regulatory affairs . Certified IRB Professional (CIP) certification. Previous clinical research… 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 ... the Regulatory Affairs , Advertising and Promotion Director. The Senior Manager Regulatory Affairs , Advertising and Promotion will oversee therapeutic… more
- Glycomine (Boston, MA)
- …Oversight Plan, etc). Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs , Translational Medicine and ... for patients, caregivers, and families. Job Description The Senior Clinical Project Manager / Clinical Project ...evaluation of adverse events and product safety issues. Oversee clinical and regulatory files, including the essential… more
- UCB (Atlanta, GA)
- …We are looking for a Global Regulatory Lead to join us in our Global Regulatory Affairs team, based in any of our Brussels (Belgium), Slough (UK) or Atlanta ... or Raleigh (US) offices. About the role The Global Regulatory Affairs Leader provides regulatory leadership tailored to the assigned candidate asset or… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC, Marketing). Minimum of… more
- Cepheid (Miami, FL)
- …Market Quality, and other Quality related functions.This position reports to the Sr. Manager Regulatory Compliance and Post Market Surveillance and is part of ... includes assessing complaints cross functionally for reportability decisions to regulatory authorities, ie, submitting Vigilance and Medical Device Reporting… more
- Katalyst HealthCares and Life Sciences (Philadelphia, PA)
- …stakeholders, including Biostatistics, Clinical Development, Quality Assurance, and Regulatory Affairs , to facilitate seamless data flow and compliance. ... database development, validation, and transfer processes in accordance with SOPs and regulatory requirements. Provide subject matter expertise in clinical data… 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 ... part of a team revolutionizing heart valve treatment! Description We are seeking a Clinical Trial Manager to lead premarket clinical studies for Capstan… more
- Hologic (San Diego, CA)
- …stakeholder departments (eg R&D, Regulatory Affairs , Marketing, Scientific Affairs ). Leads and manages cross-functional clinical team(s) in the planning ... 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 … more
- Veterans Health Administration (Los Angeles, CA)
- …22 Pathology and Laboratory Medicine Service (PALMS) is looking for a Clinical Laboratory Scientist (Hematology Technical Specialist) for the Greater Los Angeles VA ... is an "Open Continuous Announcement" that will be used for filling the Clinical Laboratory Scientist (Technical Specialist) Hematology for the Greater Los Angeles VA… more
- Veterans Health Administration (Houston, TX)
- Summary The Registered Nurse Quality & Patient Safety Nurse Manager - Utilization Management functions as a clinical expert and is responsible and accountable ... care. The Registered Nurse Quality & Patient Safety Nurse Manager ensures compliance with all regulatory and...program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Qualifications Basic Requirements :… more
- Veterans Health Administration (Long Beach, CA)
- …and equitable patient care. Ensures compliance with accreditation and regulatory standards. Aligns nursing/ clinical objectives with organizational strategic ... Summary The Nurse Manager (NM) - Outpatient Rehab Nursing is a...The NM maintain knowledge and ensures compliance with all regulatory and accreditation standards, Directives, policies, and standard operating… more
- Blue Shield of California (Oakland, CA)
- Job Description Your Work As the Program Manager , Principal, Product Strategy, you will play a central role in supporting the strategic development, evaluation, and ... will help translate strategy into execution across multiple initiatives that span clinical , technical, and policy domains. This is a cross-functional role that… more
- Veterans Health Administration (White River Junction, VT)
- …Nationals or those who owe allegiance to the US Videos Duties This Clinical Laboratory Scientist position is within the Pathology and Laboratory Service at the ... White River Junction, Vermont location. This position is full-time. The Clinical Laboratory Scientist (CLS) is responsible for evaluating, performing, interpreting,… more
