Healthcare & Pharma Careers

The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life.. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it.. Exciting Opportunity at MSK: We’re looking for a Clinical Trials Nurse in Lymphoma to join our team!. Participate in an individualized training/orientation program geared to teaching or reinforcing the principles of Clinical Trials Nursing practiced at MSKCC. Hours: 4, 10 hour days shifts flexed Monday - Friday, no weekends no holidays

Melissa Owens| President P: (386)339-0839 |E: melissa@alliedsearchpartners.com Schedule a Meeting: Job Description Job Title: Senior Quality Assurance - Permanent Location: Alameda, CAShift: Flexible work schedule, start time between 7am and 9am local time / Hybrid - at least 4 days per week.. Job Summary: A passionate Senior Quality Assurance Specialist to play a vital role in ensuring the quality and compliance of our products business.. The person in this position will collaborate with various departments, including manufacturing, R&D, and regulatory affairs, to review documentation, conduct/host audits, investigate deviations, lead projects, and help manage document lifecycles.. Additionally, the Senior Quality Assurance Specialist will perform back-up quality control duties.. Requirements: Knowledge of quality tools/concepts and their application such as Document Control/Change Control, Deviations, Corrective/Preventive Action, Internal Audit, batch record review, statistical process control, etc.

The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for clinical trials and marketing authorizations for the bioproduct portfolio.. Knowledge of bioproduct CMC global regulatory requirements and guidelines for conducting clinical trials and obtaining global product marketing registrations. Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members. Knowledge in new molecular modalities (e.g., oligonucleotides, cell and gene therapy) preferred but not required.. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities.

Job DescriptionMission of the Role: As a Clinical Research Physician/ Neurologist you will provide clinical mentorship and leadership for clinical development and clinical trials conduct within our organization.. You will operate in a wide range of aspects in clinical and pharmaceutical medicine and with patients, health authorities, colleagues, and biopharmaceutical companies.. Your role will be focused on phase I-IV clinical trials, where you will be responsible for assessing and following the safety of clinical trial participants and collaborate with the team with all aspects of clinical and scientific input and safety evaluation.. Essential Duties and Responsibilities: Provide clinical expertise into the conduct of clinical trials.

Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Business Unit Medical Affairs, Rheumatology - Immunology Clinical Research Physician (CRP) is an integral member of the medical affairs and business unit team for strategic planning in the support of launch and commercialization activities to meet patients' needs and ultimately enhance the customers' experience in interacting with the company.. The CRP may also work closely with global Development teams, Therapeutic Area Program Phase, Early Phase/Clinical Pharmacology, and Translational Medicine teams in new product development activities over the entire spectrum of drug development and clinical trial phases.. Contribute to the development of medical strategies to support brand commercialization activities by working closely with the regional and affiliate Medical Affairs and brand teams, Global Patient Outcomes/Real World Evidence and global PRA, clinical management or personnel and other cross-functional management during the development of the local business plan.. Assist in the planning process and participate in study start-up meetings and other activities to provide the appropriate scientific training and information to investigators and site personnel.. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities.

Do you want to join an organization that invests in you as a(an) Pharmacy Operations Manager?. We are looking for a dedicated Pharmacy Operations Manager like you to be a part of our team.. The Pharmacy Operations Manager provides managerial support to the Director of Pharmacy and other Pharmacy Department Leadership through day to day departmental leadership and coordination of pharmacy workflow.. HCA Healthcare Co-Founder. Our Talent Acquisition team is reviewing applications for our Pharmacy Operations Manager opening.

We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio.. You will be responsible for creating CMC regulatory strategies that facilitate first-pass approvals of regulatory submissions.. Prepares CMC regulatory product strategies.. Represents CMC regulatory affairs on teams such as product development, Global Regulatory Product Teams, and Operations brand teams for assigned projects; negotiates with and influences team members with the support of management to maximize chances for first-pass approval of regulatory submissions.. Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company.

We do this through strategic and complimentary areas of focus: Asset Optimization and Commercialization, Value Access and Outcomes, Medical Strategy and Communications, and Real-World Evidence.. The Director of Regulatory Affairs is a senior leadership position within our consulting firm, responsible for providing strategic guidance and expert knowledge in the field of regulatory affairs to clients in various industries.. The Director of Regulatory Affairs will oversee a team of regulatory specialists and collaborate closely with clients, internal teams, and external stakeholders to achieve regulatory compliance and facilitate successful product development and market access.. Prepare and review regulatory submissions, such as marketing applications, clinical trial applications, labeling, and post-market surveillance reports.. Additional compensation may include incentive compensation (i.e. bonus or commission), if applicable.

Head of Regulatory Affairs - IGT-D. Head of Regulatory Affairs – Image Guided Therapy Devices (IGT-D). There are key opportunities to build regulatory capabilities in minimally-invasive interventional devices, as well as drive efficiencies through regulatory operations excellence.. Leading the Global IGT-D Regulatory Affairs team from end to end (product inception through to lifecycle management), driving significant innovation, actively providing value-added regulatory affairs input and deliverables for new product introductions and product changes across the globe.. Leading strategy and execution of functional excellence to improve performance of the regulatory function and ultimately bring increased value to the IGT-D Business Unit.

he Associate Director of Regulatory Affairs will oversee regulatory strategy and compliance for clinical research initiatives within the Penn Colton Center for Autoimmunity, operating under the Institute for Immunology & Immune Health (I3H).. Drive strategic planning for clinical research regulatory operations while anticipating and adapting to regulatory changes. Provide strategic direction, management, mentorship, and oversight for regulatory operations team. Choose from a wide variety of investment options through TIAA and Vanguard.. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.

Our hospitals have been named among the Top 5 percent of all U.S. hospitals by Healthgrades and a five-star hospital by the Centers for Medicare & Medicaid Services.. Located just 30 minutes from the beach, TidalHealth offers the widest array of specialty and subspecialty services such as neurosurgery, cardiothoracic surgery, joint replacement, emergency/trauma care, comprehensive cancer care, wound care and clinical trials and research.. Investigational Drug Services Manager Position Summary As an integral member of the healthcare team, the Manager of Interventional Drug Services (IDS) is responsible for planning, monitoring, and directly supervising pharmacy personnel in the safe and effective use of investigational drugs and protocols approved by the Institutional Review Board (IRB).. Experience in the following areas is preferred: regulatory affairs, clinical trials, project management, and team building.. Investigational Drug Services Manager Benefits At TidalHealth, team members working at least 36 hours per pay period based on 12-hour shift schedules or at least 37.5 hours for non 12-hour shift schedules and part-time team members working at least 30 hours or more on weekends only are eligible for benefits.

This role will be responsible for guiding dose optimization, assessing pharmacokinetics, and investigating drug interaction potential.. The Director will collaborate closely with cross-functional teams, including Clinical, Research, DMPK, Biometrics, Translational Medicine, Regulatory, and CMC, to drive effective development strategies.. Integrate clinical pharmacology insights with a broad understanding of related areas such as clinical development, biostatistics, regulatory affairs, nonclinical studies, and research to inform development decisions.. Education: Ph. D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, or a related field.. Regulatory Knowledge: Prior experience with NDA/BLA/MAA filings is preferred, along with experience in authoring and responding to health authority inquiries.

This role requires an extensive knowledge of the roles and responsibilities of Regulatory Affairs spanning both clinical and commercial phases of drug development, and how Regulatory Affairs connects with other functional areas.. Has experience specifically in the Regulatory Affairs Global Labeling function.. ESSENTIAL DUTIES AND RESPONSIBILITIES:Leads and manages the Exelixis Labeling Working Group on the development, review, approval, and maintenance of the Company Core Data Sheet (CCDS), Company Core Safety Information (CCSI), USPI, EU SmPC and Rest of World (RoW) labeling.. Maintains labeling documents in the electronic document management system and relevant labeling trackers as appropriate.. 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.

Provide strategic guidance as the Regulatory Affairs Inflammation subject matter expert on cross-functional/cross-regional sub-teams across development (e.g., Global Development Team, Study Management, etc.). U.S. Education & Experience PharmD/PhD with 8+ years’ relevant experience.. Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.. Experience leading global MAA filings for one or more regions and/or working extensively with global affiliates strongly preferred.. Knowledge & Other Requirements Demonstrated advanced knowledge of the drug development process, global and regional regulatory requirements for medicinal products.

The Regulatory Affairs Specialist will oversee the implementation of quality systems and strategies to ensure the company's products meet regulatory standards, driving continuous improvement across production lines.. My client is a global provider of scientific and analytical solutions specializing in biopharma, clinical, and food & beverage industries.. Their portfolio includes advanced technologies for liquid handling, cell line development, and osmolality testing, backed by strong customer service and support.. Ensure post-market surveillance compliance and manage product lifecycle.. Knowledge of post-market surveillance processes.

Compass Healthcare Consulting & Placement is conducting a search for an experienced Associate of Regulatory Affairs for a large Managed Care Insurance Plan in the Bronx, NY. Qualified candidates will have prior Managed Care, MLTC, Managed Care Plan experience with Compliance and Government Regulations.. Regulatory Affairs Associate will be responsible for the planning, development, direction, delivery, evaluation, and coordination of activities within our Regulatory Affairs Department.. Juris Doctor, JD Degree, Required. Minimum 3 years of experience in MLTC, managed care contracting, credentialing, and compliance.. Strong knowledge of MLTC, MAP, Medicaid, and Medicare programs.

Clinical Trials Specialist-Full Time-PRMO-Durham-Remote Work Arrangement: Requisition Number: 244015 Regular or Temporary: Regular Location: Durham, NC, US, 27710 Personnel Area: PRMO Date: Jul 8, 2024 At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community.. The primary role is to facilitate accurate billing for patients enrolled in clinical trials in accordance with federal regulations to reduce both institution al and individual provider legal and financial risk.. General Description of the Job Class Facilitate accurate billing for patients enrolled in clinical trials in accordance with federal regulations to reduce both institutional and individual provider legal and financial risk.. Facilitate communication between the clinical research coordinators and the CDM department to insure compliance with DUHS and SOM rules regarding uniform discounted fees for clinical trials.. Required Qualifications at this Level EducationHigh school diploma or equivalent is required, preferably supplemented by post-secondary courses in Accounting, Finance, Economics, Business Administration or a related field.

Clinical Research Associate II (CRA II) - Position Title: Clinical Research Associate Function: Clinical Service Overview: This individual will be responsible for managing clinical activities at study sites conducting studies for the Medical Devices group, as well as, fostering strong, productive relationships with colleagues within the Medical Devices Group.. Education A Bachelor Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.. Experience Typically requires Bachelors degree with at least 2 years of relevant experience; Masters or PhD/MD/PharmD with at least 1 year of relevant experience.. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.. It’s the ripple effect that changes and improves everything for your family, your community, and the world.

We are seeking a dedicated and experienced Assistant Director of Nursing (ADON) for a personal care agency that targets helping individuals that need assistance with personal hygiene, toileting, dressing, mobility, eating, light house keeping, and other activities of daily living. The ADON will assist in overseeing the clinical operations of the home care services, ensuring high-quality patient care, compliance with state and federal regulations, and support for our nursing staff.. Stay updated with industry trends and best practices in home health care.. Bachelor’s degree in Nursing (BSN) preferred; an Associate’s Degree in Nursing (ADN) with relevant experience will be considered.. Proficiency in electronic health records (EHR) systems.

A Day in the LifeAs Principal Regulatory Affairs Specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies.. Team with business unit Regulatory Affairs Specialists (RAS) to provide regulatory support for new product introduction (NPI) and marketed products under MDD and MDR Regulation.. As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class IIa & Class III devices and preparing and submitting regulatory submissions in the EU and supporting outside of US (OUS) geographies.. Prepare Technical Files /Design Dossier, Change Notifications, Submissions (e.g. Documentary Audits under MDD/ MDR)Creates, reviews and approves engineering change requests.. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.