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Detailed understanding of regulatory and professional guidelines associated with the compliant dissemination of medical information and HCP engagement (OIG, FDA, AMA, ACCME, and PhRMA guidelines.
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Job DescriptionThe PositionReporting to the Director in Regulatory Chemistry, Manufacturing and Controls, the Senior Scientist is responsible for implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned biological products in accordance with global regulations, guidance's and defined regulatory strategies.
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Knowledge of federal, state, and local fleet and safety regulatory requirements (DOT, FMCSA, OSHA, EPA, etc. Asplundh is the parent company of Asplundh Infrastructure Group whose subsidiaries provide overhead and underground line construction, planning and design, meter reading and AMR/AMI installation, electrical testing, and street lighting/traffic signal services.
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Depth of knowledge and practical use with regulatory guidelines including but not limited to CFPB, FDIC, FRB, OCC, and NCUA compliance examination procedures. As a Regulatory Compliance and Operational Risk Senior Manager, you will get the opportunity to grow and contribute to our clients' business needs by providing in-depth technical knowledge on emerging regulations and help organizations leverage efficiencies within the Risk Advisory Practice - all with the resources, environment, and support to help you excel.
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As a Licensed Professional Land Surveyor (PLS) at Henkels & McCoy, you will play a pivotal role in our surveying projects, ensuring precision, accuracy, and adherence to regulatory standards. Communicate effectively with clients, project stakeholders, and regulatory agencies.
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You will be responsible for developing, and being the technical lead for new Enterprise Content Management & Composition applications based on: business requirements, regulatory requirements, architect solutions, and existing technologies.
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Collaborate with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs, to ensure seamless integration of mechanical systems into final products.
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This individual will work closely with multiple functions including Brand Marketing, Integrated Account Field Teams, Patient Engagement & Customer Solutions (PECS), Strategic Customer Group (SCG), Field Sales, Medical Affairs, Real World Value and Evidence, and external partners in order to effectively develop and deliver on key access strategies and goals.
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Partner with legal, medical, regulatory, HCC, and CPC partners to obtain approval of marketing and contracting materials. The Group Product Director for Immunology Channel Marketing is accountable for the leadership and development of channel specific strategies within Health Systems, Supergroups, Infusion Service Providers and In-Office Infusion Suites for the Immunology Portfolio, inclusive of the Gastroenterology, Rheumatology and Dermatology franchises.
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Must have national accredited wound certification(CWS, CWCN, WCC, CWON, WOC, AWCC)or be committed to complete Advanced Wound Training and national accredited Wound Certification within 1 year of hire (For those hired with wound certification, completion of a fast-track hybrid program for regulatory wound care requirements will be provided) Clinical experience in a skilled nursing setting is strongly preferred.
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The Policy Execution team is accountable to the Regulatory Digital Health team and has the responsibility to lead the receipt and triage of draft and final policies, navigate the ever-evolving digital health regulations, and to ensure the Regulatory Affairs organization is aware, understands, and implements the latest regulations and guidance's globally.
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Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices.
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Education: Bachelors degree in Business Management, Business Administration, Human Resources, Accounting or related flied Related payroll & benefits courses/training preferred Experience: Minimum of 7 years’ experience with automated payroll systems (ADP Workforce Now preferred) and/or benefits administration Understanding of the Regulatory and Legislative imperatives and impacts related to Total Rewards programs (FLSA, Sec 125, ERISA, 409A, HIPAA, etc.
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RESPONSIBILITIES OF WOUND CARE NURSE:Ensure that all nursing personnel in our facility comply with established standards, practices, and regulatory requirements for the highest quality of resident care.
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LICENSE AND REGULATORY REQUIREMENTS: Education: A high school diploma or the equivalent plus completion of a certifying technical training program in electrical maintenance or completion of an electrician's apprenticeship is required.
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regulatory affairs jobs Company: Caltrans in Horsham, PA
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