The IRB Regulatory Consultant will oversee regulatory operations of studies conducted by one or more Disease and Modality Team within Montefiore Einstein Cancer Center, including, internal (investigator-initiated studies), Cooperative group, and industrial protocols (pharmaceutical and biotechnology...
Oversee regulatory operations of clinical studies for one or more disease and modality teams. Experience in working with FDA regulations and guidelines, 21 CFR, ICH guideline and initiatives governing regulatory operations and submissions (Pharma, Biotech, Medical Devices). Previous working or educa...
Group Benefits Compliance Manager. This role involves managing the compliance program for the Group Benefits business, which includes products like stop loss, li. ...
Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures requi...
Conducts analyses based on operational, market, economic and/or financial data in order to build business cases and models to derive business insights and inform decisions. Solid business operations knowledge to include understanding and monitoring of the OTC market, syndicated data (IRI) and other ...
Perform the compliance activities of the portfolio to determine regulatory impact and associated submission requirement for clinical and commercial regulatory filings in accordance with country specific regulatory guidance documents. Support CMC development activities from a regulatory standpoint du...
CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compl...
Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures requi...
Perform data validation to ensure accurate data movement into the enterprise data warehouse architecture. Production Support Data Analyst. Collaborate with business stakeholders and IT teams to analyze and resolve data issues within the enterprise data warehouse. Demonstrated experience in data anal...
A typical day might include the following:Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compliance (beyond GMP compliance) are met and fully support clinical supplyCollaborates cross-functionally to support the submission strategies and impacts on supply and regul...
In this role, a typical day might include the following:Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and info...
CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compl...
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Subscribe to FlexJobs today and gain access to 25,000 hand-screened remote, work from home, & flexible schedule job listings.FlexJobs makes it easier, faster, and safer to find a job that better fits your life with professional job opportunities from entry-level to executive, startup to Fortune 500 ...
The supporting data models will pull data from various sources, including legacy Excel models/data sets, SharePoint lists, SQL Server databases, and more. The Data Analyst will support and assist a team of analysts in performing analytics. Expertly assist in providing direction and/or developing Pow...
HCM Business Analyst | HRIS Business Analyst | HR Business Analyst. The Business Analyst will support Digital HR. PMP) or Scrum Master Certification, business analyst certification is a plus. You will collaborate with HR stakeholders, IT teams, vendors, and other relevant departments to ensure the s...
Mercedes Benz of White Plains is seeking to fill an immediate opening for a Sprinter Commercial Van Sales Consultant. Work with management to finalize sales, obtain financing for potential clients, and ensure customer satisfaction. Prior commercial van sales experience a plus!. ...
FlexJobs was founded in 2007 and has been featured on NPR, Good Morning America, Fox Business Channel, and thousands of other media outlets. ...
Job Description: Anti-Fraud Team is looking for an Analyst and Associate level compliance Business analyst to support a project. The Analyst will be working on a project within the Anit-Fraud team. ...
As an Manager a typical day might include, but is not limited to, the following:. You demonstrate a proven track record of establishing and maintaining effective working relationships with managers and employees as well as influencing individuals of various levels to gain understanding and/or accept...
Regulatory Affairs Certification (RAC) is a plus. Demonstrated expertise in preparing CMC sections of regulatory submissions (, INDs, NDAs, BLAs, MAAs, IMPDs) and interacting with global health authorities (, FDA, EMA, Health Canada, PMDA). Strong understanding of global regulatory requirements, gui...
The Operational Compliance Analyst will be pivotal in ensuring our aviation teams are provided with robust data analysis & risk management, contributing to strategic decision-making across departments. Data Analysis: Utilize statistical tools & techniques to explore data, identify patterns, relation...
As The Retail Manager within our Amenity Services team , you will lead the development and execution of the retail and office pantry strategy at JPMorgan Chase's new global headquarters at 270 Park Avenue. Analyze market trends and consumer insights to refine program strategies. Long-term program st...
Areas of Responsibility and Job RequirementsEnsure compliance with all regulatory requirements for a mix of sites that include both Section 8 and LIHTC units and/or Public Housing Authority’s (PHA) regulatory and leasing requirements for a Section 8 Project Based Voucher (PBV) property, if applicabl...
The Compliance Manager will develop and implement compliance policies and procedures, work with internal and external partners on compliance matters, and ensure regulatory reporting and adherence to privacy and data security laws such as HIPAA. Group Benefits Compliance Manager. The role requires se...