Regulatory & Clinical Scientist - Lead FDA Studies
hims & hers
Hims & Hers is seeking a Senior Scientist, Regulatory & Clinical Operations to join our Central New Jersey laboratory. This role reports to the Director of R&D and leads the execution of FDA-regulated studies in collaboration with a contracted CRO. The ideal candidate blends bench science with clinical study execution, translating regulatory rigor into practical decisions. On-site lab work in Central New Jersey is essential. #J-18808-Ljbffr hims & hers
- Hims & Hers is seeking a Senior Scientist, Regulatory & Clinical Operations to lead coordination of FDA-regulated studies in our Central New Jersey on-site lab. The role sits at the intersection of bench science and clinical study execution, reporting to the Director of...Regulatory
- Adlai Nortye seeks a Clinical Trial Manager with 3-8 years of experience to lead planning, execution, oversight and delivery... ...and company SOPs. You will manage study timelines, budgets, CROs and... ...outcomes across Phase I-III, with regulatory submissions and inspection readiness...Regulatory
$96.8k - $137k
...for all.We are looking for a Clinical Research Specialist for Dermal... ...and external clinical/case studies.Monitor the conduct of external... ...to explore new technical leads, active ingredients and product... ...Research & Implementation, Safety, Regulatory, Legal, Marketing) to review...RegulatoryHourly payLocal areaRelocation$117k - $184.2k
Job DescriptionThe Senior Clinical Scientist provides scientific leadership... ...partners with Clinical Directors, Study Managers, Clinical... ...Management, Statistics, and Regulatory colleagues to ensure the scientific... ...LeadershipServe as the lead Clinical Scientist for assigned...RegulatoryFull timeFor contractorsLocal areaFlexible hours$173.2k - $272.6k
...DescriptionUnder the direction of Clinical Data Management and GDMS... ...Clinical Data Management Indication Lead, Late Oncology provides... ...and high-quality delivery of study and program data. The... ...Practice), study protocol and regulatory adherence. Ensure documentation...RegulatoryFull timeFor contractorsLocal areaFlexible hours- Spectraforce Technologies is seeking a Clinical Research Scientist - III for a remote role with flexible scheduling. The position... .... The role emphasizes development and review of study concepts, protocols, CRFs, and regulatory submissions, with supervision across multiple...RegulatoryRemote jobFlexible hours
- Job Title: Clinical Research Scientist - III Duration: Potential for conversion following... ...design to develop specific study concept sheets and... ...the preparation/review of regulatory documents, IND annual reports... ...and provide direction. May lead two or more specific components...RegulatoryRemote workFlexible hours
$173.2k - $272.6k
Job Description The Clinical Imaging Scientist (Principal Scientist) leads complex imaging deliverables for assigned clinical... ...areas, supporting programs from study planning through closeout. The... ...imaging service providers Provide regulatory-facing imaging expertise to...RegulatoryRemote jobFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$294.48k - $386.51k
...Executive Director, Pipeline Clinical Lead as part of the Clinical... ...human through proof of concept studies, with accountability for... ...execution, interpretation, and regulatory interactions. The Pipeline... ...a team of physicians and scientists, work closely with cross functional...RegulatoryPermanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours- ...CORE JOB RESPONSIBILITIES: Assist the Clinical Research team to interface with project... ...Data Management, Statistics, Drug Safety, Regulatory and Project Management. Review and query... ...as appropriate). Assist with clinical study report preparation to include narrative...RegulatoryPermanent employmentContract workWork at officeImmediate start
- As a Clinical Scientist within the Early Clinical Development Group, you will have responsibility... ...and clinical pharmacology programs and study implementation. You will have an unparalleled... ..., analysis plans, study reports and regulatory submissions in collaboration with...RegulatoryWork experience placementLocal area
$32 - $50.73 per hour
...Medical Laboratory Scientist II - Edison, NJ, Monday to Friday, 6:0... ...analysis to ensure accuracy of clinical data and proper instrument... ...Participate in government or regulatory agency inspections, if needed... ...absence of a Supervisor, to assume lead responsibilities if qualified...RegulatoryFull timeWork experience placementWork at officeLocal areaMonday to FridayFlexible hoursWeekend work- ..., New Jersey, seeks an experienced clinical data management leader. The role involves... ...operating procedures, and ensuring regulatory compliance across clinical studies. Ideal candidates will have over 9... ...position offers an opportunity to lead data management efforts for...Regulatory
- ...Peter’s Healthcare System in New Brunswick, NJ, seeks a part-time Clinical Research Associate to support observational and interventional studies. You will coordinate study activities, maintain regulatory documents, and liaise with investigators, staff, IRB, and...RegulatoryPart time
$210.4k - $331.1k
...Medicine (TMed) drives early clinical development of novel therapeutics... ...spanning first-in-human studies through proof-of-biology/proof... ...clinical supplies, data management, regulatory, etc.) across departments,... ...strategic initiatives and lead continuous‑improvement...RegulatoryFor contractorsWorldwideRelocationVisa sponsorshipFlexible hours$22 - $23 per hour
SGS in Union, New Jersey is looking for a Clinical Research Coordinator to lead and coordinate studies while ensuring compliance with Good Clinical Practice (GCP). The role includes executing daily tasks such as data collection, document review, and scheduling subjects...Hourly pay- ...alignment to the QMS while optimizing time to regulatory approval/clearance. Work with suppliers... ...: engineering drawing review, capability studies, gage RRs, special process validations,... ...of Suppliers and ensures compliance with FDA QSR and ISO13485 requirements, and...Regulatory
- ...Clinical Research Scientist At Real we're always looking for new and ambitious people to help deliver exceptional service levels, change the... ...a key role to assist the global clinical development, regulatory, and safety to continually assess and analyze clinical safety...RegulatoryLocal area
$10k
...hiring a Medical Laboratory Scientist II in Perth Amboy, NJ. This role... ...complexity testing) in a clinical laboratory setting.Preferred... ...Participate in government or regulatory agency inspections, if needed... ...absence of a Supervisor, to assume lead responsibilities if qualified...RegulatoryFull timePart timeWork experience placementWork at officeLocal areaMonday to FridayFlexible hoursShift workWeekend workAfternoon shift$40.79 - $52.03 per hour
...complex diagnostic laboratory testing to support clinical decision‑making and ensures compliance with regulatory standards. This role applies advanced technical expertise... ...as a Medical Technologist or Medical Laboratory Scientist. Benefits and Perks Paid Time Off (PTO) Medical...RegulatoryHourly payTemporary workPart timeFlexible hoursShift work- ...Biological, Chemical, Physical science or equivalent · One-year clinical laboratory experience preferred Certification and Licensure... ...population including team members, providers, patients, regulatory and accrediting agencies, and other members of the public Physical...RegulatoryWork at officeNight shift
- ...NJ is hiring a Weekend Nursing Supervisor to lead our nursing team on weekend shifts. This RN-led... ...CNAs, ensuring care plans are followed and regulatory standards are met. You'll act as the go-to decision-maker for clinical concerns, resident condition changes, and family...RegulatoryShift workWeekend work
- Atlantic Health System in New Jersey is seeking a Medical Laboratory Scientist to process specimens, perform high- and moderate- complexity... ...issues and report accurate results. You will ensure regulatory compliance, maintain quality control, operate and calibrate equipment...Regulatory
$28.85 - $37.5 per hour
...Lab Technologist is an advanced technical role responsible for leading and supporting product development, pilot-scale processing,... ...supports scale-up to ensure products meet customer expectations and regulatory requirements. The role requires close collaboration with cross...Regulatory- ...Supervisor), the Medical Lab Scientist will play a critical role in... ...Testing program across various clinical departments and offsite... ...practices, ensuring compliance with regulatory standards, and promoting... ...New Jersey, we are one of the leading non-profit health care systems...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsFor subcontractorFlexible hoursShift work
$38.55 - $50.53 per hour
...experience. Summary Job The Medical Laboratory Scientist MLS, Medical Technologist MT performs a... ...range of complex laboratory tests on clinical specimens to support the diagnosis,... ...expertise, quality assurance practices, and regulatory compliance standards while collaborating...RegulatoryHourly payFull timeTemporary workFlexible hoursShift workDay shift$117k - $120k
AMNEAL PHARMACEUTICALS Regulatory Affairs Specialist: With minimal supervision... ...the Food and Drug Administration (FDA) as required, within company timelines... ...incumbent serves as regulatory lead on cross functional teams including Clinical, CMC, Quality, and Marketing. Assists...RegulatoryFor contractorsLocal area- Atlantic Health System is seeking a Medical Laboratory Scientist to operate, maintain and troubleshoot lab instruments, perform high/moderate... ...testing, and report accurate results in alignment with regulatory standards. The role emphasizes quality control, proficiency testing...Regulatory
$120k - $190k
...Lead Nurse Practitioner (FT) Days - Hospitalist - New Brunswick... ...Completes diagnostic and therapeutic studies - Orders diagnostic... ...physician - Works within legal, regulatory, and ethical practice... ...: -Medical and broad based clinical emergency medicine knowledge...RegulatoryWork experience placementShift workNight shiftWeekend workWeekday work$32 - $50.73 per hour
...Medical Laboratory Scientist II - Edison, NJ, Monday to Friday, 6:00 AM to... ...analysis to ensure accuracy of clinical data and proper instrument function... .... Participate in government or regulatory agency inspections, if needed. Assume lead responsibilities when a...RegulatoryFull timeWork experience placementWork at officeMonday to FridayFlexible hoursWeekend work
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