Healthcare & Pharma Careers

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.. MSK is dedicated to training the next generation of scientists and clinicians, who go on to pursue our mission at MSK and around the globe.. Participate in an individualized training/orientation program geared to teaching or reinforcing the principles of Clinical Trials Nursing practiced at MSKCC.. Location: MSKCC, New York, NY, USA. MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment.

Associate Director/Director Regulatory Affairs Consultant. As the AD/Director of Regulatory Affairs, you will support global clinical trials and development activities as part of a high-performing global regulatory function.. As Regulatory lead on multidisciplinary clinical study teams, provide input on the documentation and procedural requirements defined by Regulatory Authorities, including submission delivery strategy, document review, and analysis of procedures used during development.. 5+ years in Regulatory Affairs in a pharmaceutical, biotechnology, or related industry is required.. Regulatory Affairs, clinical, Oncology, clinical trial submissions, CTIS, project management, Microsoft Office

They are seeking a highly accomplished and strategic Sr. Director/VP of Regulatory Affairs & Quality Assurance (RA/QA) to spearhead their regulatory and quality initiatives, with a critical focus on driving PMA and IDE submissions and bolstering their robust Quality Management System (QMS).. Develop and implement comprehensive regulatory strategies for Class III stent products, driving successful PMA and IDE submissions.. Lead the preparation, submission, and management of PMA and IDE applications, ensuring meticulous attention to detail and adherence to timelines.. Drive continuous improvement initiatives to enhance the effectiveness of the QMS.. Proven track record of successfully leading PMA and IDE submissions.

Job Title: Regulatory Affairs Specialist. Our client is seeking an experienced Regulatory Affairs Specialist to lead regulatory strategy and submissions for medical devices.. Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or a related field.. 3-5 years of regulatory affairs experience within the medical device industry.. Regulatory Affairs Certification (RAC) or equivalent credential (preferred).

The University of Cincinnati Cancer Center (UCCC) Clinical Trials Office is an institutional resource within the University of Cincinnati College of Medicine and UC Health that provides administrative, nursing, and data management support for cancer clinical trials conducted by UC Investigators.. Liaises and works efficiently in collaboration with the CTO Assistant Director and with other departments at the University to ensure adequate financial accounting regarding clinical research projects, including budget development and reconciliation.. Interacts daily with the CTO Regulatory Manager, CTO Data and Quality Assurance Manager, CTO Assistant Director to ensure all protocol requirements are met.. Clinical Research Coordinator (CCRC) or Clinical Research Associate (CCRP) certification.. REQ: 96941 SF:OMJ SF:RM SF:HEJ, SF:INS SF:HERC SF:DIV SF:LJN SF:IHE Clinical Research Manager, UC Cancer Center Date: Oct 18, 2024 Location: Cincinnati, OH, US #job-location.

M3 Wake Research is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs).. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.. We are looking for a Physician - Neurologist to join our growing team.. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement and insightful market research.. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.

This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems

This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems

Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services.. Client Services As the corporate subject specialist in regulatory affairs, provide regulatory, ethics and/or pharmacovigilance guidance and support to project stakeholders.. Project Support Regularly respond to registration requests and work with project teams to identify regulatory requirements.. Qualifications Applicants should have a minimum of an undergraduate degree and 4-6 years of relevant experience in Clinical Research/Regulatory Affairs.. Working Conditions Home-based *Accommodations for job applicants with disabilities are available upon request.

Position Overview: The Regulatory Affairs Associate will support the regulatory functions for a global medical device company.. Post-Market Surveillance: Assist in the collection, evaluation, and reporting of post-market data to regulatory authorities as required (e.g., adverse event reporting, recalls, safety notices).. Support the management of vigilance systems to ensure regulatory reporting requirements are met and assist in root cause analysis for any post-market issues.. Assist in the preparation of regulatory reports to senior management on the status of filings, approvals, and market access.. Location: Baldwin, NY Job Type : Full-time Pay : $65,000.00 - $75,000.00 per year Benefits: 401(k) Dental insurance Health insurance Paid time off Vision insurance Schedule : 8 hour shift Day shift Monday to Friday Weekends as needed Application Question(s) : How many years of Regulatory Affairs do you have?

Be at the forefront of cell therapy innovation by joining scientists, industry veterans, and healthcare visionaries and help transform how autoimmune diseases are treated.. We are looking for candidates with a proven track record in Clinical/Nonclinical Regulatory Affairs within the biotechnology or pharmaceutical sector.. Minimum of 2-5+ years of industry experience in Regulatory Affairs within the biotechnology or pharmaceutical sector.. Extensive knowledge of regulatory requirements, including ICH and regional requirements and an understanding of current global and regional trends in regulatory affairs.. Experience with cell or gene therapy regulatory affairs.

In this role, the VP of Regulatory Affairs will draw on extensive experience and strong leadership and organizational skills to develop and implement the global regulatory strategy for all company assets.. Lead the Regulatory Team that may include external consultants or other Clinical or CMC Regulatory Affairs personnel, Regulatory Medical Writing, Quality Assurance and Pharmacovigilance and Drug Safety functions.. Lead all interactions with regulatory agencies including coordination of Pharmacovigilance/Drug Safety reports.. Minimum of ten years of experience in regulatory affairs within the biopharmaceutical industry.. Knowledge of FDA regulations and EU CTA requirements required.

This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems

Associate Director, Medical Writing Who we are: Agios is a biopharmaceutical company that is fueled by connections.. 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.. The impact you will make: Agios Pharmaceuticals is searching for a dynamic Associate Director, Medical Writing to join our growing Regulatory Affairs & Medical Writing team.. What you bring: 7+ years as a medical or scientific writer, or equivalent professional or educational experience (eg, graduate degree in life sciences).. Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.

The Medical College of Wisconsin (MCW) brings a synergy between the best medical education, research and patient care.. In the role ofa Clinical Research Quality Assurance Specialist Iyou will beworking in our Cancer Center.. PurposeUnder close supervision the Clinical Research Quality Assurance Specialist I is responsible for the oversight of clinical research study protocols with an emphasis on quality, training, monitoring, and the development of tools for study team use.. The Clinical Research Quality Assurance Specialist I will coordinate the day-to-day administrative activities of the program and will provide support to teams to facilitate the achievement of the program’s goals.. Assist in resolving clinical research non-compliance through root cause analysis, corrective, and preventative action plansKnowledge – Skills – Abilities Basic knowledge of FDA regulations, ICH GCP, institutional and departmental policies and procedures.

Senior Representative, Regulatory Affairs Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide.. The Regulatory Affairs department is accountable for the direct management and guidance regarding the organization’s cGMP compliance and regulatory affairs for biologics, sterile injectables, cell and gene therapy, inhalation manufacturing and analytical services.. The main responsibility of a Senior Regulatory Affairs specialist is to serve as a regulatory liaison to clients and internal functional departments.. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting.

This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems

Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology.. Ensure that highest standards of data quality and study participant safety are maintained, as well as adherence to study protocols, CenExel SOPs, Site Working Practices (WPs), ICH GCP, Code of Federal Regulations, and IRB Guidelines.. Assists the QA Manager in the development, implementation and follow-up of quality assurance programs including necessary or appropriate policies and guidelines. Performs ongoing review of a percentage sampling of study inclusion/exclusion, study procedure records, and laboratory reports to ensure that they are conducted according to the protocol, applicable SOPs, ICH/GCP guidelines and federal regulations.. Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.

We are currently seeking a detail-oriented and knowledgeable Medicaid EVV Biller to join our billing team.. The ideal candidate will have experience in electronic visit verification (EVV) processes and a strong understanding of Medicaid billing procedures.. The Medicaid EVV Biller will be responsible for ensuring compliance with Medicaid billing regulations and electronic visit verification requirements.. Knowledge of healthcare billing codes, insurance claims processing, and relevant regulations.. Certification in medical billing or coding (e.g., CPC, CCA) is a plus.

A mid-size and growing medical device manufacturer specializing in class III vascular devices are looking for an experienced Director of Regulatory Affairs to drive regulatory excellence in this field.. Ensure compliance with FDA, EU MDR, and other international regulatory requirements for high risk medical devices.. 10+ years of regulatory affairs experience in the medical device industry, with some experience in class III devices (ideally vascular).. Strong knowledge of FDA regulations, EU MDR, and other global regulatory requirements.. Join a forward-thinking company at the forefront of vascular access.