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At Alexion (AstraZeneca's Rare Disease unit), work centres on people living with rare conditions whose journeys demand new thinking every day; this means operating at the edge of science while staying grounded in real patient stories, collaborating across subject areas to turn complex biology into transformative medicines, learning fast in an entrepreneurial environment with the backing of a global biopharma, and growing through tailored development that deepens both leadership capability and compassion for patients and communities we serve. Role Overview: The Senior Manager, Regulatory Affairs US lead will be responsible for leading, planning, preparing and delivering regulatory strategies and activities for assigned product(s)/project(s) across the assigned jurisdiction supporting global regulatory strategies, with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.

YEAR

AstraZeneca is one of the world’s most exciting bio-pharmaceutical companies. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that improve patients’ lives and benefit society. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world.

AstraZeneca Plc

Senior Manager, Regulatory Affairs US Lead

Directing multidisciplinary teams that develop proofs of concept, experiments, and production-ready applications using machine learning, natural language processing, image analysis, time series analysis, graph-based methods, and retrieval-augmented generation techniques. Establishing and overseeing end-to-end validation approaches for AI-enabled solutions, including data review, design assessment, testing strategy, benchmarking, sensitivity analysis, documentation, traceability, monitoring, and production-readiness evaluation.

Deloitte

Manager, AI Risk & Validation

ea_via_bold

Position Purpose: The Regulatory CMC Senior Manager is responsible for contributing to the development of Stoke's products by supporting global CMC regulatory strategies, leading lifecycle management initiatives, and providing regulatory guidance to cross-functional teams for multiple programs. Key Responsibilities: Prepares and executes global regulatory CMC strategy for development programs and future commercial programs, including new applications, information amendments, annual reports, supplements/ variations, and responses to health authority questions.

Stoke Therapeutics, Inc.

Senior Manager, Regulatory Affairs, CMC

FULL_TIME

The Manager of Information Technology provides direct supervision of IT staff, oversees infrastructure and cybersecurity initiatives, manages disaster recovery and business continuity planning, and ensures exceptional customer service and operational excellence throughout the organization. The Manager of Information Technology is responsible for providing strategic leadership, planning, implementation, administration, and support of the organization's technology infrastructure, cybersecurity program, cloud services, enterprise applications, and end-user computing environment.

Homes for Our Troops

IT Manager

partner JazzHR

Administer and support commercial platforms (e.g., Salesforce, Veeva Vault), including user management, basic configuration, troubleshooting, and coordination of more complex changes with vendors. You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested, which may include travel by air, driving or public transportation.

Amylyx Pharmaceuticals

Manager, IT Commercial And Medical Affairs Applications

Provides leadership to individuals and interdisciplinary teams assure oversight of process and outcome measures, and collaborates with the Director of Regulatory Affairs and Performance Improvement on the reporting of clinical quality measures to Joint Commission, CMS and MassHealth to meet regulatory requirements. Reporting to the Chief Medical Officer, responsible for the oversight, leadership and direction of the healthcare quality and patient safety programs for Mount Auburn Hospital and Mount Auburn Professional Services' (MAPS) ambulatory practices.

Lahey Hospital and Medical Center

Director of Quality & Patient Safety, Mount Auburn Hospital

ADAPTED_NOW

4. Provides ongoing program education for new staff, including new Case Managers, the Trainee program hires, social workers, physicians, nurses and allied health professionals as it relates to discharge planning and utilization review. 3. Ongoing development and completion of continuing education programs for Clinical Resources Management staff, including case managers and social workers specifically related to role functions and implementation of new processes.

WEEK

Windsor Healthcare Recruitment Group, Inc.

Travel Nurse RN - Manager - $2,952 per week

One Red Cent - Marketplace

Acts as project manager throughout the pitch and proposal response lifecycle including, but not limited to: conducting opportunity assessments; tracking opportunities; developing project plans; organizing and conducting kick-off calls with lawyers and colleagues; gathering and drafting relevant content; coordinating with client pricing, BD and other business professional colleagues; incorporating competitive intelligence to tailor responses; and ensuring high quality/error free proposals are submitted. 8 years' relevant experience includes directing the project management and development of RFP responses in a professional services environment; possessing a thorough understanding of the proposal process in a competitive professional services marketplace; and having demonstrated experience managing several concurrent projects under tight deadlines.

DLA Piper LLP (US)

Disputes Pursuits & Directories Manager

Serve as the regulatory lead on study teams, as assigned, and provide regulatory guidance regarding clinical development plans, trial design, endpoints, safety requirements, and submission strategy. Your impact: The Associate Director/Director of Regulatory Strategy will play a pivotal role in leading strategic regulatory initiatives for the bipolar indication of our lead program, RAP-219.

Rapport Therapeutics Inc

Associate Director/Director, Regulatory Strategy

This leader sets the tone for a white-glove client experience while driving revenue growth through proactive relationship-building, effective team management and a disciplined approach to identifying and converting opportunities. NBTC.com or follow Northern Bank on Facebook (/NorthernBankM A/), Twitter (@northernbankma), Instagram (@northernbankma) and LinkedIn (company/northern-bank-ma/).

Northern Bank

Sales & Service Manager, AVP

The VP will lead cross-functional collaboration across Regulatory Affairs, Technical Operations, CMC, Quality, Clinical Development, Supply Chain, and external partners to ensure successful advancement of programs from early development through commercialization. Position Purpose: The Vice President, Regulatory Strategy & CMC is responsible for leading teams to develop and execute global regulatory and Chemistry, Manufacturing & Controls (CMC) strategies across the company's product portfolio.

Vice President, Regulatory Strategy And CMC

Understand the impact of key technology trends and workforce changes impacting our clients through engagement with innovative and emergent technologies, including cloud computing, big data and analytics, process automation, artificial intelligence / machine learning, and other digital strategies. A minimum of 8+ years working in the financial services or consulting industry related to any of the following Financial Services/capital markets industries: investment banking, broker-dealer, prime brokerage, wealth management, or related technology service provider.

Manager - Capital Markets Operations And Technology

Applying and interpreting U.S. federal income tax law as it relates to tax due diligence exercises, including Subchapter C corporations, partnerships, consolidated groups, corporate bankruptcies and insolvencies, tax efficient structuring and use of debt, the reorganization provisions of the Internal Revenue Code. Due diligence and interpreting complex legislative and regulatory actions relating to corporate and partnership transactions, assisting clients with regulatory and legislative initiatives, and preparing for client review submission requests for private letter rulings and technical advice from the IRS.

<p>PwC’s accounting practice originated in London well over a century ago. As times changed and PwC expanded worldwide, our commitment to clients—like you—never wavered. With us, you’re always supported by a global network of more than 223,000 people in 157 countries with one goal: to help your business thrive.</p>

<p>PwC’s professional services include audit and assurance, tax and consulting that cover such areas as cybersecurity and privacy,  human resources, deals and forensics. We help resolve complex issues and identify opportunities across these industries.</p>

<p>Let’s combine your ​aspirations with our world-class capabilities to achieve your goals.</p>

Mergers And Acquisition Tax, Senior Manager

The EHS Consulting Senior Manager leads a portfolio of consulting and embedded services accounts, pairing deep technical EHS expertise with account leadership to deliver outstanding client outcomes, grow relationships, and develop a high-performing team. Triumvirate Environmental provides leading organizations in the higher education, life sciences, healthcare, and advanced manufacturing sectors with diverse services and expertise to assist them with compliance management.

Triumvirate Environmental

EHS Consulting Senior Manager

Degree in Engineering (Mechanical, Chemical or Biomedical preferred); Master’s Degree in and 3-5 years’ experience in product development (Medical Device Industry experience is preferred) or Bachelor’s Degree in Engineering and 5-7 years’ experience in product development; 3+ years of leadership roles in project management, Project Management Professional (PMP) certification a plus; 5+ years of product development experience, preferably in the medical device industry; Working knowledge of CAD systems (SolidWorks and Inventor), and preferably prior FEA experience; Prior experience in the design of biomaterials highly desired; Proficiency in understanding and applying of design controls, and their development; A strong understanding of manufacturing processes using state of the art technologies; and process improvement techniques (Six Sigma Green or Black Belt preferred). The ability to lead multi-cultural, multi-discipline teams in developing medical products; The ability to develop and effectively manage project timelines independently or within a project team; The ability to maintain design control documentation, budgets, and project files; The ability to develop and perform product testing to include mechanical and physical testing and finite element analysis; The internal motivation and ability to personally drive a project and gain support from various required resources from within and outside of the company; The ability to build positive relationships inside and outside the Company, and to effectively communicate project status that might affect related research and development work for other programs; and.

RevBio, Inc.

R&D Project Manager

This position is responsible for providing overall management of defined research areas including team personnel supervision, complex pre-award and post-award functions for all federal and non-federal grants and contract proposal preparation and approval, establishment of account infrastructure, management of financial transactions, preparation of regular reporting on status of funding and approval of research expenditures. Manager will oversee post award work in their areas of responsibility such as working with Principal Investigators and Program Managers to submit written and electronic requests for unobligated balance carryforwards, change of Principal Investigators, no cost extensions, relinquishing statements and any other federal Grants Management Specialist requests.

Beth Israel Lahey Health

Manager Research Administration

About Vinfen: Established in 1977, Vinfen is a nonprofit, health and human services organization and a leading provider of community-based services to individuals with mental health conditions, intellectual and developmental disabilities, brain injuries, and behavioral health challenges. Vinfen's 3,500 dedicated employees are experienced, highly-trained professionals who provide a full range of supportive living, health, educational, and clinical services in over 550 sites throughout Massachusetts and Connecticut.

<h4>For 40&nbsp;years, Vinfen has been dedicated to transforming lives. We are a leading provider of community-based services to people with psychiatric conditions, intellectual and developmental disabilities, brain injuries, and behavioral health challenges. Our dedicated staff uses the latest in science-based interventions to support the people we serve in achieving their goals and leading more independent, productive, and valued lives as members of their community.</h4>
<h4>Vinfen is one of the most dynamic and innovative health and human services organizations in the country. With over 200 locations in Massachusetts and Connecticut, we are a premier provider of comprehensive services for adolescents and adults with disabilities or life challenges. We provide a wide range of evidence-based programs in recovery, supported living, habilitation, education, employment, clinical, and peer support to the populations we serve. <br />&nbsp;&nbsp;<br />Vinfen&rsquo;s commitment to excellence is evident in our employees across the company, who are all dedicated to supporting and empowering the people we serve. At Vinfen, we are all about transforming lives together.</h4>

Vinfen

Day Habilitation Site Manager

[AW]-iCims

In the U.S., Grant Thornton delivers professional services through two specialized entities: Grant Thornton LLP, a licensed, certified public accounting (CPA) firm that provides audit and assurance services ― and Grant Thornton Advisors LLC (not a licensed CPA firm), which exclusively provides non-attest offerings, including tax and advisory services. With $2.7 billion in revenues and more than 50 offices spanning the U.S., Ireland and other territories, the platform delivers a singular client experience that includes enhanced solutions and capabilities, backed by powerful technologies and a roster of 12,000 quality-driven professionals enjoying exceptional career-growth opportunities and a distinctive cross-border culture.

Grant Thornton International Ltd

Finance AI Manager

As a key operational leader, the Manager collaborates closely with Southcoast Physicians Group practice management, medical providers, health center leadership, hospital departments, community partners, and laboratory leadership to optimize service delivery, strengthen provider relationships, and identify opportunities for expansion of outpatient laboratory services across the Southcoast Health system. The Manager, Laboratory Outpatient Services provides strategic and operational leadership for Southcoast Health''s outpatient laboratory network, ensuring exceptional patient, provider, and customer service across a complex, multi-site healthcare environment.

Southcoast Health System Inc

Manager, Laboratory Outpatient Services

Well over 100 years later, we are the largest meat processor in New England and still pushing our craft to the next level - tweaking recipes to have the perfect flavors and extending our expertise into delicious new areas and collaborations - such as Kayem's Night Shift Brewing Small Batch Beer Brats. Kayem Foods is a family owned and operated craft meat business that has been making New England's favorite franks, sausages, and prepared meats in Chelsea, Mass.

Jobs in Eden, NC

Senior Manager, Regulatory Affairs US Lead AstraZeneca Plc

Manager, AI Risk & Validation Deloitte

Senior Manager, Regulatory Affairs, CMC Stoke Therapeutics, Inc.

IT Manager Homes for Our Troops

Manager, IT Commercial And Medical Affairs Applications Amylyx Pharmaceuticals

Director of Quality & Patient Safety, Mount Auburn Hospital Lahey Hospital and Medical Center

Travel Nurse RN - Manager - $2,952 per week Windsor Healthcare Recruitment Group, Inc.

Disputes Pursuits & Directories Manager DLA Piper LLP (US)

Associate Director/Director, Regulatory Strategy Rapport Therapeutics Inc

Sales & Service Manager, AVP Northern Bank

Vice President, Regulatory Strategy And CMC Stoke Therapeutics, Inc.

Manager - Capital Markets Operations And Technology Deloitte

Mergers And Acquisition Tax, Senior Manager PwC

EHS Consulting Senior Manager Triumvirate Environmental

R&D Project Manager RevBio, Inc.

Manager Research Administration Beth Israel Lahey Health

Day Habilitation Site Manager Vinfen

Finance AI Manager Grant Thornton International Ltd

Manager, Laboratory Outpatient Services Southcoast Health System Inc

Environmental, Health & Safety Manager Kayem Foods Inc

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