Collecting information
Organizing data
Corporate Compliance Officer.. The Corporate Compliance Officer is primarily responsible for leading the corporate compliance program, under the direction of leadership, including managing and implementing the compliance work plan, implementing necessary policies and procedures, conducting investigations related to detected offenses, and managing the day-to-day operations of the Compliance program. 5 years’ compliance work experience in Compliance, revenue integrity, billing, finance, coding, auditing, and/or a combination of the above. CHC (Certified in Healthcare Compliance) or CPCO (Certified Professional Compliance Officer).. Knowledge and experience in Health information privacy laws, access, release of information and release contract technologies.
Design and perform engineering analyses pertaining to radio frequency interference to and from geostationary and non-geostationary satellite systems. Provide technical support on market access and business development activities. Knowledge of satellite communications systems (g., link budgets, general radio theory and basic orbital mechanics); national, regional and international spectrum policies and regulation, registration and coordination processes. Understanding of policy and regulatory issues in the satellite sector, especially with regard to licensing and market access. Learn more about Viasat’s comprehensive benefit offerings that are focused on your holistic health and wellness at
The Surgical Coordinator plays a critical role in ensuring the seamless planning and execution of orthopedic surgical procedures within a healthcare setting.. The Surgical Coordinator is responsible for scheduling surgeries, managing pre-operative preparations, and facilitating post-operative follow-ups to optimize patient outcomes.. Ultimately, the Surgical Coordinator contributes to the overall success of the orthopedic surgical team by streamlining processes and enhancing patient experience throughout the surgical journey.. Certification as a Surgical Coordinator or Certified Medical Administrative Assistant (CMAA).. The required orthopedic knowledge enables the Surgical Coordinator to understand the specific needs and nuances of orthopedic surgeries, facilitating accurate scheduling and patient preparation.
The Executive Director, CMC Regulatory Affairs is responsible for developing and directing the regulatory CMC strategy, objectives, and programs pertaining to development and marketing of drug products.. Lead teams with regulatory CMC responsibility for support of development, registration and life cycle support, and CMC regulatory strategy for United States and EU. Creates and implements CMC regulatory strategies for CTA submissions and marketing applications.. Provides proactive guidance to internal groups (Quality, Manufacturing, etc) based on technical and CMC regulatory knowledge towards development of strategic and tactical plans.. BS, BSc, MS, MSc, PhD, PharmD, in science or healthcare preferred or equivalent relevant experience.
As a dedicated Advocacy Advisor-Intermediate , you will within defined guidelines and framework, provide timely , accurate and compliant responses for complaints identified and addressed to USAA's Executive Management Group, Chairman and Board of Directors, general consumers, and/or regulatory agencies.. This position can be based in one of the following locations: San Antonio, TX, Phoenix, AZ, Colorado Springs or Tampa, FL. Relocation assistance is not available for this position.. Risk and Root cause analysis background (efficient and effective research capabilities-de-escalation background beyond live phone calls, i.e. outbound campaigns, remediation efforts, etc. Compensation: USAA has an effective process for assessing market data and establishing ranges to ensure we remain competitive.. You are paid within the salary range based on your experience and market data of the position.
Then come join us, at NHC Healthcare Oakwood!. You will provide direct and indirect patient care activities under the direction of a Registered Nurse or Licensed Practical Nurse. With this position you will gain a certificate that will certify you as a Certified Nursing Assistant.. Becoming a Certified Nursing Assistant OPENS doors to so many opportunities and avenues, not just healthcare!. Becoming a Temporary Nurse aide and then becoming a CNA!
Regulatory Affairs Specialist - Post Market - req1434.. Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is responsible for complaint handling, coordination of product recalls, FMI processes, processing electronic submissions and state registrations. Assist in maintaining proper preparedness for State or Federal (FDA) authorities.. 2 Years Regulatory Affairs experience in medical device industry required.. Canon Medical Systems USA, Inc., a world leader in diagnostic imaging, is in search of qualified candidates to fill our open positions.
Ensure Exelixis development and commercialized products are manufactured in accordance with approved chemistry, manufacturing and control (CMC) requirements. Provide CMC Regulatory expertise for commercial and development projects. Work closely with the PSC/CMC, Regulatory Affairs, and Quality Assurance departments, as well as with cross-functional project teams. Liaise internally with other members of the Regulatory Affairs department to coordinate CMC changes with other aspects of the development programs. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
Kellen is an association management firm seeking an experienced professional to serve as a Senior Manager/Director of Technical and Regulatory Affairs to support clients in the food industry.. The ideal candidate will have a strong background in food science, nutrition, and regulatory affairs, with demonstrated experience navigating the regulatory landscape.. Monitor and develop comments to relevant scientific, nutrition, and regulatory policy proposals, and recommend actions, as needed, engaging with appropriate client groups on final industry positions in response to government agencies (e.g., Food and Drug Administration, U.S. Department of Agriculture).. Bachelor’s degree or higher in a discipline related to science (e.g., food science, nutrition, public health) or a related field, and 5-7 years’ related field experience is desired.. This job can be located in Washington, D.C or Chicago, IL. Kellen operates in a hybrid working environment (i.e., working both in the office every Tuesday and Wednesday and remotely other days of the week).
Senior Regulatory Affairs Specialist, NPD. Join to apply for the Senior Regulatory Affairs Specialist, NPD role at Kelly Science, Engineering, Technology & Telecom.. Kelly Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a one-year contract with a leading molecular diagnostics company based in Sunnyvale, CA. This role offers an opportunity to contribute to cutting-edge scientific advancements and advance your career in biotechnology.. Position Title: Senior Regulatory Affairs Specialist, New Product Development. Evaluate and ensure labeling accuracy for Cepheid’s in vitro diagnostic products.
We are 29,000 strong and operate over 1,500 pet care centers in the U.S., Mexico, and Puerto Rico, including 250+ Vetco Total Care hospitals, hundreds of preventive care clinics, and eight distribution centers.. Identify and assess contractual and business risks; communicate legal and compliance issues to management and recommend mitigation strategies, utilizing internal and external resources.. Bachelor's degree and 5+ years of experience in contract management, legal operations, or commercial negotiations.. Proficiency with contract management systems and Microsoft Office Suite; experience with tools like DocuSign, Salesforce, or CLM platforms is a plus.. Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.. Agios Pharmaceuticals is searching for a dynamic Associate Director, Regulatory Affairs Strategy to join our growing Regulatory team.. Sr Regulatory Affairs Specialist. Sr. Manager/Associate Director, Regulatory Affairs Strategy and Labeling. Senior Consultant - Regulatory Operations Software Implementation (Remote)Senior Consultant - Regulatory Operations Software Implementation (Remote)Associate Director, Global Labeling Devices
Senior Regulatory Affairs Manager - Oncology.. Senior Regulatory Affairs Manager – Oncology.. Bachelor’s degree in Life Sciences, Engineering, or related discipline with at least 7 years of relevant regulatory affairs experience in an IVD regulatory affairs role, preferably in molecular diagnostics or closely related area; OR an advanced degree with at least 5 years of relevant experience in an IVD/CDx regulatory affairs role. Proven success in authoring and leading FDA regulatory submissions and interactions, including PMAs, sPMAs, 30-Day Notices, 510(k)s, and IDE submissions. GH will consider qualified applicants with criminal arrest or conviction histories in a manner consistent with applicable law including but not limited to the LA County Fair Chance Policies and the Fair Chance Act (Gov. Code Section 12952).
RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein.. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.. Education equivalent to a BS or MS, plus 5 years of hands-on regulatory experience, orEducation equivalent to a higher degree (PharmD or PhD), plus 3 years of hands-on regulatory experience.. Experience using Veeva RIM and SmartSheets. Preparing/Writing de-novo regulatory meeting requests/ briefing books
Clinical Trial Regulatory Affairs Specialist (Boston, MA) Hybrid role. Regulatory Compliance: Ensuring all clinical trials adhere to applicable regulations and guidelines, including FDA, EMA, and ICH standards.. Experience: A minimum of 10 years in regulatory affairs within the biotechnology or pharmaceutical industry, with direct involvement in clinical trial regulatory processes.. Knowledge: Strong understanding of clinical trial regulations, Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and ethical standards.. Education: Bachelor’s or master’s degree in regulatory affairs, life sciences, or a related field.
Who We Are: Galaxy is a global leader in digital assets and data center infrastructure, delivering solutions that accelerate progress in finance and artificial intelligence.. We believe that blockchain and digital asset innovation will transform how value moves through the world – and we’re building the products and services to make that future a reality.. We are seeking an experienced regulatory affairs and compliance specialist to join the Galaxy Data Centers team where you will assist in ensuring compliance with grid related market rules or statutes for data centers.. In addition to ensuring compliance, you will attend Independent System Operator (“ISO”) or Public Utility Commission (“PUC”) stakeholder meetings, workshops, and discussions to advocate for Galaxy’s position within the relevant market.. Direct, recent experience within the ERCOT and PUCT stakeholder environment
We have marketed a range of products across therapeutic categories, including ANTARA (fenofibrate) and METHERGINE (methylergonovine maleate), as well as launching Inspira Chamber (valved holding chamber), Brovana Inhalation Solution, and Xopenex HFA. While these brands treat a wide range of medical conditions, they have one important commonality: they are part of a sincere effort to broaden the treatment landscape for the benefit of patients and providers alike.. We are building our specialty business in therapeutic areas where we have synergy, including respiratory and neurological diseases.. Evaluate competitive landscape and various regulatory mechanisms that allow optimization of product development (e.g., orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, pediatric plans) and present options and recommendations to expedite the path to market, as applicable.. MSc level degree preferably within the life sciences (PharmD, PhD preferred). Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Inhalation and Neurology and Other therapeutic areas)
Product Owner Global Regulatory Affairs (m/f/d) City: Various Locations. Minimum 8 years of experience, working in life science technology environment, preference in scientific technology. Good understanding & experience with RIM Functional Processes – Registrations Management, Submission Planning, Submission Content Planning, Document Management, Publishing etc.. As a science-based, privately-owned pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide.. Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America and the US. Our products are available in more than 100 countries.
Work with the Compliance Department to implement new GRC tools related to policies.. Proficiency in Microsoft Word, Excel, and PowerPoint and Governance, Risk & Compliance solutions.. Northern Trust provides a comprehensive benefits package including retirement benefits (401k and pension), health and welfare benefits (medical, dental, vision, spending accounts and disability), paid time off, parental and caregiver leave, life & accident insurance, and other voluntary and well-being benefits.. If you need a reasonable accommodation for any part of the employment process, please email our HR Service Center at MyHRHelp@ntrs.com.. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email our HR Service Center or call 1-800-807-0302 (North America), +630-276-5353 (Asia Pacific), 1800-425-0333 (India), +44(0)207 982 4357 (Europe, Middle East and Africa) and let us know the nature of your request and your contact information.
This position is responsible for all regulatory affairs and rates related functions in multiple jurisdictions.. The Manager will support the Regional Director, on other regulatory matters and organizational strategies on a periodic basis.. Provide regulatory leadership and advice to direct and indirect reports to ensure regulatory compliance and to maximize earnings at the local state level.. Leads project planning and analysis preparation in support of major rate cases, as well as pre-filed testimony and exhibits.. Defined Contribution savings plan