- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …US regulatory framework. Regulatory PolicyScans the horizon for upcoming regulatory policy topics across all key markets and aligns within DS functions ... is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through direct and indirect line management, to identify and… more
- Aequor (Washington, DC)
- …Mon - Fri 9 AM - 1 PM EST SCOPE OF RESPONSIBILITIES: accountable for supporting regulatory policy efforts within the Regulatory Science and Policy team ... dietary supplements, cosmetics, foods, and medical devices) Responsibilities: Monitor emerging regulatory policy issues, including issues arising from North… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …globally- Creates a forward-looking Diagnostic development strategy while keeping abreast of regulatory and policy updates in the external environment and by ... Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liasions to ensure successful implementation of CDx and data collection-… more
- Merck & Co. (North Wales, PA)
- …in regulatory affairs.NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this ... Job DescriptionThe Director, Regulatory Affairs Liaison, is responsible for development and implementation... policy are required to have a minimum of twelve (12)… more
- Merck & Co. (North Wales, PA)
- …and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional ... practices are consistent with regulatory guidelines, our company's policies, and support business objectives.Serve as the liaison and manages correspondence with… more
- Merck & Co. (North Wales, PA)
- …for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance ... Principal Scientist will lead the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr. Scientist and Assoc… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference?The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines. You ... will lead a global regulatory team to develop and execute regulatory ...also offers time off pursuant to its sick time policy , flex-able vacation policy , and parental leave… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory ... to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data standards, data quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic ... oncology pharmaceutical products. Provides innovative approaches to resolve complex regulatory issues and increase speed to patients.ResponsibilitiesCDx development: Provide… more
- UNC Health (Garner, NC)
- …promoting cost-effective care. Gives feedback to co-workers. Is aware of public policy and regulatory guidelines affecting the health care environment. Promotes ... a safe, clean and secure hospital environment for all.5. Patient Assessment - Recognizes data from complex situations to determine priorities for care. Includes appropriate physical, psychosocial, education and safety needs. Synthesizes assessment data into… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... related drug/vaccine projects in Late Development Statistics.Interacts with Clinical, Regulatory , Statistical Programming, Data Management, and other company Research… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... projects in Late Development Statistics.Lead the interaction with Clinical, Regulatory , Statistical Programming, Data Management, and our company's Research… more
- Merck & Co. (Rahway, NJ)
- …site, region and global business partners to drive prioritization of regulatory compliance, continuous performance improvement, and integration of EHS performance ... are completed in accordance with identified target dates.Review and/or approve regulatory permits, inspection outcomes and audit report findings to assure… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical, Regulatory , Statistical Programming, Data Management, and our Company's Research… more
- Merck & Co. (Rahway, NJ)
- …language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.Manages country deliverables, timelines and ... and updates country information in clinical and finance systems.Ownership of local regulatory and financial compliance. The position has a significant impact on how… more
- Merck & Co. (Rahway, NJ)
- …of formulation, manufacturing processes, and packaging to enable phase-appropriate regulatory filings for oral products.- This research-based team contributes to ... technical & domain expertise, effective communication skills, understanding of the regulatory environment, and vision to influence the regulatory … more
- Merck & Co. (Washington, DC)
- …for managing company issues at the federal level, including public policy initiatives for the business, leading engagement legislative processes, partnering on ... regulatory engagement and working with stakeholders via direct relationships,...responsibility for leading the development and execution of public policy work as it relates to our Company's Animal… more
- Insmed Incorporated (Bridgewater, NJ)
- …oversee safety pharmacology and toxicology studies, author nonclinical sections in regulatory submission documents, and address regulatory inquiries. This ... areas, ensuring alignment with company objectives and in compliance with regulatory guidelines and industry standards.Provide scientific guidance on study design,… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... coordinators Conduct routine safety observations to ensure compliance with regulatory agencies, company environmental, health, and safety policies, procedures and… more
- Merck & Co. (North Wales, PA)
- …position provides high quality statistical programming analysis and reporting and regulatory submission deliverables for Real World Evidence projects across the ... patterns and disease progression, answer clinical development questions, and support regulatory submissions.- In this role, the principal statistical programmer will… more
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