Jobs in Ardsley, New York

Best Match

Senior Director Regulatory Affairs

acorda_therapeutics Village of Ardsley, NY

The Senior Director - Regulatory Affairs is responsible for managing Regulatory Affairs activities (nonclinical and clinical) for assigned investigational and/or marketed products. This individual manages the development of regulatory strategies for development of investigational drugs and post-approval marketed product support; preparation, review (for content and format), and filing of documents to health authorities, in particular investigational new drug applications (INDs) and/or marketing applications (NDAs/MAAs). This individual is expected to be capable of serving as the Regulatory Project Lead for assigned projects, responsible for establishing and implementing regulatory strategy, acting as primary contact with relevant health authorities and representing Regulatory Affairs on the project team. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Develops and implements regulatory strategies to support investigational drug development and filings of INDs and NDAs for assigned products. Leads regulatory activities, including planning and reviewing of nonclinical and clinical sections of regulatory submissions for format and content. Develops and manages regulatory submission project timelines for assigned projects. Coordinates and prepares company responses to information requests from health authorities. Acts as the primary company contact to health authorities for assigned investigational drugs and marketed products, including leading meetings with health authorities and business partners. Maintains in-depth knowledge/awareness of federal regulations and policies regarding development of investigational agents and maintenance of marketed products to optimize Acorda regulatory strategies. Responsible for Regulatory input into product labeling, including coordinating development of product label, utilizing internal or external regulatory labeling resources. Supports assigned marketed products with regulatory review of product labeling and advertising materials. Maintains and in-depth awareness of relevant federal and international regulations and policies to optimize Acorda’s regulatory strategic input to assigned project teams for investigational and marketed products. Undertakes ongoing performance review, feedback and development of staff. Assists with talent recruitment and leads a highly motivated, efficient and effective team. Responsible for training and mentoring associates on the Regulatory Affairs Team. EDUCATION AND/OR EXPERIENCE: Bachelor’s degree in Chemistry or Biology or Science related field required. Master’s or Ph.D. degree in Chemistry, Biology, or Science related field preferred. Minimum of ten years progressive experience in a regulatory affairs position preferred. Minimum of 15 years experience in the pharmaceutical or biotechnology industries. SUPERVISORY RESPONSIBILITIES: This individual may supervise associates in the regulatory affairs group. QUALIFICATIONS: Must have demonstrated experience in filing INDs and annual reports in an e-CTD format; a strong knowledge of FDA/ICH regulatory guidelines; excellent verbal and written communication skills; work well with employees across the organization and strong interpersonal skills, and tactful negotiation skills. Some knowledge of CMC regulatory guidelines and global drug development is preferred. COMPUTER SKILLS: Must be proficient in MS Office Suite. Experience with DocCompliance and MedXview or other web-based document management/publishing software for electronic submissions preferred. CERTIFICATE, LICENSES, REGISTRATIONS: RAC (US) preferred; RAC (EU) and (CAN) preferred. OTHER SKILLS AND ABILITIES: Excellent writing, communication, and presentation skills. Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast paced environment. Strong skills in planning, organizing, decision-making and problem-solving. Demonstrated leadership and project management skills. Ability to serve on multiple interdepartmental teams and to act as team leader when appropriate. Demonstrated ability to stay abreast of trends and new information. PHYSICAL DEMANDS: The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. This position requires travel; the average travel for this position is 10-15% (both domestic and international including overnight) with some variation based upon the demands of the business imperatives. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. No specific work demands. *To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. #J-18808-Ljbffr

Dynamic Environment

Caregiver HHA Daily Pay Available

Elara Caring Village of Ardsley, NY

Job Description: Pay: $19.15 $750 Sign-on Bonus Based on hours worked. Join our Elara Caring family and become a superhero of care! We're on a mission to keep people in their homes safely, one client at a time. Why Choose Elara Caring? We've got an awesome team environment where everyone supports each other. Daily Pay Available! Work today, get paid tomorrow. Need a flexible schedule? We've got you covered. Paid travel time between assignments? Yes, please! Paid orientation and training, plus hundreds of free online classes available to support anything you may need. Ready to climb the career ladder? We've got opportunities for advancement waiting for you! Medical, dental, and vision benefits. What do you need to bring to the table? A big heart and a passion for helping people with tasks like bathing, housekeeping, and meal prep. Reliable transportation to zoom to your clients' homes and spread joy. You might need to do some occasional heavy lifting (up to 50 pounds). We value the unique skills of veterans and military spouses. We encourage applications from military veterans and their families. Elara Caring provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to sex (including pregnancy, childbirth or related medical conditions), race, color, age (40 and older), national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity, gender reassignment, protected veteran status, or any other basis prohibited under applicable federal, state or local law. Elara Caring participates in E-Verify and we will provide the Federal Government with your Form I-9 information to confirm that you are authorized to work in the United States. Employers like Elara Caring can only use E-Verify once you have accepted the job offer and completed the Form I-9. If you are an individual with a disability and are unable or limited in your ability to use or access our career site as a result of your disability, you may request reasonable accommodations by reaching out to [email protected]. Click below for a glimpse into the day in the life of an Elara Caregiver! #J-18808-Ljbffr

Work Life Balance

Document and Quality Management Systems Administrator

acorda_therapeutics Village of Ardsley, NY

The Document and Quality Management Systems (QMS) Administrator is responsible for system administration of all IT systems supporting the Quality Assurance departments in Chelsea and Ardsley. Quality Assurance documents are managed in one or more Document Management Systems while quality assurance processes are managed by a Quality Management System. The Document and Quality Management Systems Administrator coordinates with department heads to design quality management processes to meet specific business requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES Include the following. Other duties may be assigned. Supports business owners who create quality assurance documents and procedures. Performs technical System Administration for the Document Management and Quality Management Systems. Investigates system problems and coordinates fixes or functional enhancements with application vendors. Assists business owners with “workarounds” if system functionality cannot be fixed or enhanced. Manages interfaces to other Acorda Information Technology Systems. Participates in the implementation and upgrades of Quality Management and Document Management Systems. Serves as the Super User for Document Management and Quality Management systems. Provides customer support to users as needed. Maintains liaison with software vendors for product issue escalation, product enhancement requests, user groups, and product news such as upcoming release features and schedules. EDUCATION AND/OR EXPERIENCE: Associate's degree in Computer Information Systems, or equivalent knowledge, required. Equivalent knowledge may be obtained by having applicable, up-to-date software vendor certification. Bachelor’s degree in Computer Information Systems preferred. Minimum of three years' IT support experience required. Prior experience with one or more QMS, such as QUMAS DocCompliance, QUMAS Process Compliance, Sparta Trackwise, Microsoft Office 365, or Adlib Render Server required. Experience with other business applications such as Novatus, Veeva, E*Central, Argus, Oracle ERP, or SAP preferred. Experience in Web development such as JAVA, .NET, HTML, XML, SQL, Jasper Studio preferred. SUPERVISORY RESPONSIBILITIES: None QUALIFICATIONS: Good project management and organization skills. COMPUTER SKILLS: Must be proficient in MS Office Suite. Must be familiar with multiple browsers: Chrome, IE, Safari. CERTIFICATES, LICENSES, REGISTRATIONS: Business Application support certification preferred. Any technical certification a plus. OTHER SKILLS AND ABILITIES: Exhibits superior customer service skills. Excellent written and verbal communication skills. Performs duties independently in a highly dynamic, fast-paced business environment. Demonstrates attention to detail. PHYSICAL DEMANDS: The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. This position requires minimal travel; average travel for this position is 5-10% with some variation based upon the demands of the business imperatives. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. No specific work demands. *To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. #J-18808-Ljbffr

Senior Director Regulatory Affairs

Acorda Therapeutics Ardsley, NY

The Senior Director - Regulatory Affairs is responsible for managing Regulatory Affairs activities (nonclinical and clinical) for assigned investigational and/or marketed products. This individual manages the development of regulatory strategies for development of investigational drugs and post-approval marketed product support; preparation, review (for content and format), and filing of documents to health authorities, in particular investigational new drug applications (INDs) and/or marketing applications (NDAs/MAAs). This individual is expected to be capable of serving as the Regulatory Project Lead for assigned projects, responsible for establishing and implementing regulatory strategy, acting as primary contact with relevant health authorities and representing Regulatory Affairs on the project team. *ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Develops and implements regulatory strategies to support investigational drug development and filings of INDs and NDAs for assigned products. Leads regulatory activities, including planning and reviewing of nonclinical and clinical sections of regulatory submissions for format and content. Develops and manages regulatory submission project timelines for assigned projects. Coordinates and prepares company responses to information requests from health authorities. Acts as the primary company contact to health authorities for assigned investigational drugs and marketed products, including leading meetings with health authorities and business partners. Maintains in-depth knowledge/awareness of federal regulations and policies regarding development of investigational agents and maintenance of marketed products to optimize Acorda regulatory strategies. Responsible for Regulatory input into product labeling, including coordinating development of product label, utilizing internal or external regulatory labeling resources Supports assigned marketed products with regulatory review of product labeling and advertising materials. Maintains and in-depth awareness of relevant federal and international regulations and policies to optimize Acorda’s regulatory strategic input to assigned project teams for investigational and marketed products. Undertakes ongoing performance review, feedback and development of staff. Assists with talent recruitment and leads a highly motivated, efficient and effective team. Responsible for training and mentoring associates on the Regulatory Affairs Team. EDUCATION AND/OR EXPERIENCE: Bachelor’s degree in Chemistry or Biology or Science related field required. Master’s or Ph.D. degree in Chemistry, Biology, or Science related field preferred. Minimum of ten years progressive experience in a regulatory affairs position preferred. Minimum of 15 years experience in the pharmaceutical or biotechnology industries. SUPERVISORY RESPONSIBILITIES: This individual may supervise associates in the regulatory affairs group. QUALIFICATIONS: Must have demonstrated experience in filing INDs and annual reports in an e-CTD format; a strong knowledge of FDA/ICH regulatory guidelines; excellent verbal and written communication skills; work well with employees across the organization and strong interpersonal skills, and tactful negotiation skills. Some knowledge of CMC regulatory guidelines and global drug development is preferred. COMPUTER SKILLS: Must be proficient in MS Office Suite. Experience with DocCompliance and MedXview or other web-based document management/publishing software for electronic submissions preferred. CERTIFICATE, LICENSES, REGISTRATIONS: RAC (US) preferred; RAC (EU) and (CAN) preferred. OTHER SKILLS AND ABILITIES: Excellent writing, communication, and presentation skills. Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast paced environment. Strong skills in planning, organizing, decision-making and problem-solving. Demonstrated leadership and project management skills. Ability to serve on multiple interdepartmental teams and to act as team leader when appropriate. Demonstrated ability to stay abreast of trends and new information. PHYSICAL DEMANDS: The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. This position requires travel; the average travel for this position is 10-15% (both domestic and international including overnight) with some variation based upon the demands of the business imperatives. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. No specific work demands *To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Best Match

Oral Surgeon - Concerned Dental of the Bronx

Affinity Dental Management Ardsley-on-Hudson, NY

Elevate Surgical Precision at Affinity Dental Management Are you an Oral Surgeon with a passion for precision and a commitment to excellence? Affinity Dental Management, a dentist-run organization recognized as one of the Inc 5000's fastest-growing private companies for 5 consecutive years, offers an unmatched opportunity. Our presence spans the Northeast, boasting a balanced mix of general dentistry and all dental specialties. Step into a world shaped by the latest in dental technology, including OverJet, CBCT Imaging, CEREC CAD/CAM systems, and Intraoral Imaging. Join us, and let your expertise in oral surgery not only transform smiles but also shape the future of oral healthcare.Why Connect with Affinity?Unparalleled Commitment: We believe in the confluence of science, technology, and human touch. Here, each surgical procedure is a blend of precision, care, and empathy.Advanced Surgical Suites: Benefit from state-of-the-art oral surgical facilities, ensuring you have the best tools at your disposal to deliver unparalleled care.Work-Life Balance: With Affinity, anticipate a life balanced between professional demands and personal passions, characterized by minimized administrative tasks, flexible PT/FT schedules, and opportunities to travel between offices or even relocate.Dentist-Centric Evolution: Our ethos is dentist-owned and dentist-run, promising freedom in services, mentorship prospects, and pathways to equity or partnership.Unparalleled Compensation: Experience top-of-the-market compensation packages and benefits, including health, dental, vision, and 401K.Location :Concerned Dental of the Bronx: 55 E. Mosholu Parkway, Unit E, Bronx, NY 10467Duties and Deliverables: As our revered Oral Surgeon, you will:Deliver unmatched oral surgical care, turning apprehensions into affirmationsCraft and communicate comprehensive treatment plans, ensuring patients are always informed and comfortableEmploy state-of-the-art techniques that prioritize minimal invasiveness and maximum patient comfortDiagnose and manage a vast array of oral and maxillofacial conditions, showcasing your mastery from dental implants to corrective jaw surgeriesUphold the highest echelons of professionalism and ethics, becoming a beacon of trust and reliability for our patientsStay updated with the ever-evolving realm of oral surgery, ensuring our patients always receive care that's modern, efficient, and effectiveEssential Qualifications:Hold a Doctor of Dental Surgery (DDS) or Doctor of Medicine in Dentistry (DMD) degreeCertification through The American Board of Oral and Maxillofacial SurgeryA valid NY state license for oral surgeryAcquaintance with computer systems (MS Office Word, Excel, Outlook)An innate ability to work under pressure while exuding a calming presence for our patientsDemonstrated capability for both independent decision-making and collaborative team interactionsConnecting with Affinity means:Compensation: 40-50% of collections at 98% collection rateComprehensive Benefits: Anticipate a diverse benefits package, inclusive of health, dental, vision, and 401KContinuous Learning: Access to annual CE credits, unmatched mentorship, and networking opportunities with our extensive range of specialistsUnique Incentives: Future opportunities for direct applicants may come with sign-on bonuses and relocation assistanceGrowth Ladder: Potential partnerships, leadership roles, and more await youUnveil a career where your surgical prowess isn't just utilized - it's celebrated. Align with us, transform lives one surgical procedure at a time, and etch your name as a luminary in the world of oral surgery. Affinity Dental Management awaits your unparalleled expertise.Affinity Dental Management is an equal opportunity employer committed to a diverse and inclusive workforce. We encourage qualified candidates from all backgrounds to apply and will consider all qualified applicants for employment without regard to race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age, disability, or genetic information or other characteristics protected by law. All candidates' employment is contingent on successful completion of a background check, reference check, and employment verification.{Oral and Maxillofacial Surgeon, Oral Surgeon, Dental Surgeon, Maxillofacial Surgeon, Dental Specialist in Oral Surgery, Oral Surgical Practitioner, Doctor of Dental Surgery, Facial Surgeon}PI84530e0bb577-26289-36363004

Project Manager (Construction - Manufactured Homes)

Champion Homes Ardsley, NY

Job Description Job Description Work in a place where your team values YOU. Champion Home Builder, Inc. wants YOU! We are seeking to hire a Project Manager to join our team in the region near Westchester, NY . This team takes the manufactured homes from delivery from the factory to obtaining the CO, closing out the job. WHAT DO WE OFFER? 401k plan with Company Match Paid Vacation Paid Holidays Medical Rx Dental Vision Life Insurance Company Truck WHO IS CHAMPION HOME BUILDER, INC? For decades, Champion has served as a leader in the manufactured housing industry and one of the largest mobile and modular home builders in North America. Champion offers many factory-built solutions, from single-family and multi-family homes to commercial and government buildings. Our manufactured homes, modular homes, mobile homes, park models, and commercial modular buildings can be found throughout the United States and western Canada. Throughout the organization, we act with integrity and respect. We take pride in our craftsmanship and build strong relationships with our customers, suppliers, and our employees. We know that we would not be successful without our team. In return for hard work and dedication, our goal is to provide a safe, productive, and enjoyable workplace for every employee. THERE'S NO PLACE LIKE HOMES - JOIN OURS BY APPLYING NOW! Job Title: Project Manager - Champion Construction Service FLSA Status: Exempt Region of Responsibility: Raleigh , North Carolina Summary: Champion is seeking an experienced and reliable construction professional to join and provide leadership to the team. The Project Manager will be responsible for regionally managing all projects related to the set and trim out of HUD and modular homes, ensuring projects are completed on time, within budget, and in compliance with the construction documents. This will be a service offered to our manufacturing facilities and retailers. This position will report directly to the Director of Operations. Essential Duties and Responsibilities: The key responsibilities of this position are outlined below. Other duties may be assigned. Oversee, direct, and coordinate crews with company employees and subcontractor crews to perform installation and trim out of HUD and modular homes for our retailers/builders. Will be the primary point of contact between Champion Construction Service and the retailer/builder, through our manufacturing factories in the region. Help create company-owned set crews and trim out crews, including developing the business plan and budget. Solicit and certify subcontractor crews to perform the set and factory trim out. Call on the retailer/builders to develop working relationships and market services. Process paperwork and maintain files for quotes and orders of service. Work with the divisional leadership to create tools and documents essential for doing business in the region. Taking any needed courses/tests to be certified or licensed as an installer of HUD and modular homes will be advantageous. Perform any other duties as requested. Ability to travel within the state. Qualifications: Ability to properly manage multiple projects in a fast-paced environment. Clear verbal and written communication skills to demonstrate and convey a thorough understanding of the entire development process. Must possess a strong knowledge of Word, and Excel, and be able to develop an accurate budget report, spreadsheets, correspondence, schedules, and other reporting as required. Verbal and written communication skills to audiences both inside and outside the company. Strong leadership and follow-up skills, with a "hands-on" approach to completing all projects in a timely and efficient manner. Must possess confidence and enthusiasm to network and promote services. Strong knowledge in the construction installation process and MEP's. Education and/or Experience: Ten or more years of directly related experience and/or training; Related to a 4-year degree from an accredited university or the equivalent combination of education and experience. Champion Home Builders is proud to be an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other legally protected characteristics. Champion Home Builders participates in the E-Verify Program. Background check and Drug Screen are required Job Posted by ApplicantPro

Salad Maker / Team Member

Chopt Ardsley, NY

CHOPT Salad is hiring Salad Makers. Simply apply to be contacted for an interview! Employee Safety is our #1 priority. Constant cleaning and sanitization of high traffic areas are in place and we provide daily PPE (gloves, masks) equipment to our staff. To learn more about the company go to www.choptsalad.com Pay based on experienced, availability, and position Do you like to work in a fast-paced environment? Do you like to make people happy? Do you want to be a part of a team that is changing the way America eats one salad at a time? If so, then you can be a Salad Maker for Chopt. Our customers expect a show when they enter a Chopt. It's up to our salad making professionals (aka Choprs) to ensure the service, food quality, accuracy and overall experience is Better every day. Benefits of working at Chopt: Competitive hourly rates and performance-based pay increases A clear career path with opportunities for advancement - 50% of all managers started in hourly positions Variety of Health and Wellness Benefits Pre-Tax Transit and Flexible Spending Benefits Generous PTO Policy for all employees Complimentary meal each shift Employee Assistance Resources Work Conditions/Hours: Hours will vary and may include early mornings, evenings, weekends and/or holidays All Chopt employees will be hired on a variable hour basis. Hours are scheduled based on performance and business necessities. CHOPT participates in E-Verify