Trabajos scientific director en Clifton, New JerseyCrear alertas

Minimum of 7 years of experience in pharmaceutical medical communications / publications, medical writing, or other medical affairs scientific functions, or at a medical communications agency as a medical director and/or writer. In collaboration with key stakeholders within medical affairs functions

Kenvue is currently recruiting for a: Manager, Skin Health HCP Upstream (1 of 3) What we do At Kenvue , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Who We Are Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you! Join us in shaping our future-and yours. For more information , click here . Role reports to: Senior Director HCP Marketing Neutrogena Location: North America, United States, New Jersey, Summit Work Location: Hybrid What you will do As the Manager, Skin Health HCP Upstream, you will be responsible for leading market analysis, managing key partnerships, and driving strategic marketing initiatives. You will lead the early-stage innovation pipeline, develop forecasts and recommendations, and support brand development to identify growth opportunities and optimize marketing strategies to shape the future of our professional-endorsed skin health products. We are hiring for three roles: • Manager, Neutrogena HCP Upstream - Face, • Manager, Neutrogena HCP Upstream - Sun & Hair, • Manager, Seed Brands and HCP Upstream - Rogaine Key Responsibilities, • Lead cross-functional teams to drive upstream innovation strategy and identify whitespace opportunities by integrating HCP insights, dermatology science, and emerging consumer needs to unlock new growth platforms., • Drive early-stage concept development, including problem identification, idea generation, value-proposition creation, concept writing, feasibility assessment, and iterative testing., • Collaborate with R&D and Clinical Affairs to shape claims strategy, clinical study inputs, and evidence-generation plans that meet both consumer expectations and HCP rigor., • Foster a culture of creativity, continuous improvement, and data-driven decision making within teams, including HCP engagement and marketing, to enhance professional growth and operational effectiveness., • Develop strategic frameworks and tactical plans to accelerate time-to-market while maintaining premium quality standards, building on your existing role of developing product development frameworks., • Co-create compelling product concepts and scientific narratives with R&D, marketing, agencies, and suppliers to reinforce Kenvue's leadership in Skin Health and dermatology-backed skincare., • Conduct deep consumer, HCP, and market analyses to proactively identify opportunities for differentiation and category expansion., • Lead business case development, including sizing, forecasting, pricing strategy, and scenario modeling to inform portfolio decisions., • Shape upstream HCP strategies, including professional-specific claims implications, educational needs, and evidence frameworks., • Partner with cross-functional teams to guide programs through the global stage-gate process and ensure strategic alignment., • Leverage digital tools, AI-based insights, and trend-mining platforms to identify and validate future innovation spaces., • Champion sustainability by embedding eco-friendly principles into early-stage development., • Manage performance tracking and analytics to guide long-term portfolio strategy., • Mentor junior team members and foster a culture of creativity, courage, and continuous improvement.What we are looking for Required Qualifications • Bachelor's degree or equivalent in Business, Marketing, Life Sciences, or a related field., • 6+ years of progressive experience in brand management, upstream innovation, product development, marketing, market research, or healthcare professional engagement within the beauty, pharmaceutical, healthcare, or consumer goods sectors., • Demonstrated experience conducting and interpreting consumer, HCP, and competitive insights, • Proven ability to lead early-stage concept development, claims strategy, and feasibility assessments., • Strong project leadership skills with experience guiding programs through a structured stage-gate process, • Demonstrated ability to develop and execute strategic marketing plans, including branding, positioning, and pricing strategies., • Excellent communication and influence skills across scientific, commercial, and professional audiences Desired Qualifications, • Proven track record of leading innovative projects that have resulted in measurable business growth and enhanced brand equity. Experience in beauty, skincare, sun care, or hair care innovation preferred., • Exceptional strategic thinking and problem-solving skills, with the ability to translate complex data into actionable insights and compelling product narratives., • Experience collaborating with clinical, R&D, and regulatory teams on claims and substantiation (aligned with the clinical and evidence-generation needs for HCP products)., • Familiarity with AI-driven insight tools, social listening platforms, and digital trend analytics, and forecasting software., • Experience leading global or regional upstream innovation programs., • Demonstrated ability to thrive in fast-paced, matrixed environments while managing multiple priorities and deadlines., • Passion for skincare science and consumer health, coupled with a visionary mindset to anticipate future industry trends.#LI-AO1 What's in it for you Annual base salary for new hires in this position ranges: $124,100.00 - $175,200.00 This takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors. • Competitive Benefit Package*, • Paid Company Holidays, Paid Vacation, Volunteer Time & More!, • Learning & Development Opportunities, • Kenvuer Impact Networks, • This list could vary based on location/region*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process. Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.

Job DescriptionJOB DESCRIPTION:The GCP Quality Assurance Sr. Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company’s compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day to day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials. The Sr. Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience. This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance RESPONSIBILITIES:Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials. Plan and conduct audits of specific clinical processes based on risk. Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor. Develop audit reports and distribute them to appropriate stakeholders. Own and manage related clinical vendor non-conformances. Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.). Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors. Support the preparation, coordination, and participation of regulatory agency inspections. Participate in and support quality improvement projects. QUALIFICATIONS:5+ years of pharmaceutical experience Must have experience with Radiopharmaceuticals and Quality BS degree in scientific, health care or related discipline Intensive GCP and safety background Experience with both internal and external process and systems audits Strong knowledge of development policies, procedures and standards (SOPs, QMS) Ability to work with global clinical teams in developing objectives for audits of clinical studies 10% Traveling required

Job Description The GCP Quality Assurance Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company's compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day-to-day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials. The Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience. This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies. They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance RESPONSIBILITIES: • Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials., • Plan and conduct audits of specific clinical processes based on risk., • Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor., • Develop audit reports and distribute them to appropriate stakeholders., • Own and manage related clinical vendor non-conformances., • Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.)., • Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors., • Support the preparation, coordination, and participation of regulatory agency inspections., • Participate in and support quality improvement projects. QUALIFICATIONS: • 5+ years of pharmaceutical experience, • 2+ years of RadioPharmaceutical, • 2+ years of GCP quality experience, • BS degree in scientific, health care or related discipline, • Intensive GCP and safety background, • Experience with both internal and external process and systems audits, • Strong knowledge of development policies, procedures and standards (SOPs, QMS), • Ability to work with global clinical teams in developing objectives for audits of clinical studies, • 10% Traveling required

Job Description JOB DESCRIPTION: • The GCP Quality Assurance Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Companys compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day-to-day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials., • The Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience., • This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies. They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance RESPONSIBILITIES: • Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials., • Plan and conduct audits of specific clinical processes based on risk., • Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor., • Develop audit reports and distribute them to appropriate stakeholders., • Own and manage related clinical vendor non-conformances., • Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.)., • Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors., • Support the preparation, coordination, and participation of regulatory agency inspections., • Participate in and support quality improvement projects. QUALIFICATIONS: • 5+ years of pharmaceutical experience, • 2+ years of RadioPharmaceutical and Quality Assurance experience, • BS degree in scientific, health care or related discipline, • Intensive GCP and safety background, • Experience with both internal and external process and systems audits, • Strong knowledge of development policies, procedures and standards (SOPs, QMS), • Ability to work with global clinical teams in developing objectives for audits of clinical studies, • 10% Traveling required

Job Description About Vitalief Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. Our team combines deep clinical research expertise with results-driven consulting to help organizations operate more efficiently and grow sustainably. The Role We are seeking an experienced IRB Coordinator to join our exceptional team as a full-time Vitalief employee. In this role, you will support a leading hospital research center in Livingston, NJ, administering and overseeing Institutional Review Board (IRB) activities to ensure compliance with federal, state, and institutional regulations governing human subjects research. This role supports investigators, staff, and IRB members in the preparation, review, and approval of research protocols, while also assisting with Nussbaum grant activities. WHY VITALIEF? • Contribute to advancing scientific discoveries that improve patient lives., • PEOPLE FIRST culture with opportunities for growth and innovation., • Competitive benefits including: 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans. Responsibilities: • Under the direction of the Director of Graduate Medical Education and Clinical Research, coordinate and manage all IRB activities, meetings, and communications., • Review protocol submissions for completeness and accuracy; recommend appropriate level of review., • Draft and issue correspondence reflecting IRB deliberations and decisions., • Provide regulatory and methodological guidance to investigators, staff, students, and IRB members., • Maintain compliance with OHRP, FDA, ICH/GCP, and institutional regulations., • Manage IRB databases, tracking systems, and protocol documentation., • Assist with emergency use protocols and special meetings as needed., • Schedule and support Institutional Research Committee meetings, prepare agendas/minutes, and follow up on action items., • Collaborate with other system IRB Coordinators and departmental staff., • Bachelor’s degree in a scientific or health-related field required; Master’s degree preferred., • Three (3) years of experience in clinical research and research administration, including two (2) years of IRB operations experience., • Strong understanding of IRB regulations, ethical research standards, and ICH/GCP guidelines., • Excellent written and verbal communication skills., • Ability to demonstrate professionalism, clear communication, and respect in all interactions., • Passionate in supporting teamwork and collaborative problem-solving., • Apply continuous quality improvement principles to research operations., • Work independently with accountability, sound judgment, and openness to feedback., • Strong organizational and time management abilities; must be self-motivated and able to multi-task on a variety of projects., • Detail-oriented with strong organizational and follow-up skills., • Proficiency with Microsoft Office (Word, Excel, PowerPoint); database management experience preferred., • Certified IRB Professional (CIP®) is a plus., • Knowledge of medical terminology preferred. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. #LI-DNP Powered by JazzHR oj96ccgxpc

Job Description Manager-Director, Business Development - Clinical Research Manager-Director, Clinical Business Development Full Time Remote-USA Based (Preferably East Coast) Reports to: Senior Vice President, Clinical Services Frontage Laboratories Inc. Frontage Laboratories Inc. (Frontage) is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage’s core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, clinical research, and core laboratory services for clinical trials. Frontage Clinical Services At Frontage, we leverage more than 25 years of experience to develop a unique approach to overcome the challenges of every clinical study, while maximizing efficiency and mitigating risk. We apply best practices in study design and execution to advance each study to completion. Position Summary: The Business Development role involves the creation of long-term valued business relationships for the Company with both existing and new customers, with primary emphasis on new account development. The position title can be Business Development Manager to Director depending on experience. Responsibilities: • Secure and retain business through professional, consultative, and proactive sales activities directed at key decision makers., • Strong negotiating skills, knowledge of legal contracts and experience with RFIs/RFPs and competitive bidding processes., • Analyze potential opportunities and develop sales plans for each target account, develop in-depth knowledge of the customer organization., • Ensure appropriate strategy/solution is proposed to clients., • Monitor actions and results against plans., • Lead client visits to the Frontage facilities., • Coordinate with scientific and operations staff to prepare and lead the sales presentations, present comprehensive proposals, and lead follow-up activities., • Monitor sponsor satisfaction by regular communication with the clients/sponsors., • Record all client/sponsor sales related (opportunities, CDA, MSA, Site Visits, Face to Face Meetings, etc.) activities in CRM (salesforce) system., • Represent Frontage at trade shows and other meetings. Education, Skills and Experience Required: • BS degree or above, life science preferred., • Must have 2+ years’ experience in selling Pre-Clinical or Phase 1 clinical research services., • Solid understanding of the principles of drug discovery and development., • Knowledge and experience in DMPK & Safety Toxicology, • Knowledge and understanding of FDA, GCP, and ICH regulations and guidance, • Highly proficient in using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel., • Attention to detail and ability to work simultaneously on multiple priorities. Able to adapt and be flexible to changing priorities., • Excellent oral and written communication skills., • Ability to travel., • Established industry client network is a plus. Salary and Benefits: Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Job DescriptionJob Title: GCP Auditor/Senior Auditor, Quality AssuranceJob Description This position focuses on ensuring GXP compliance with regulatory authorities, driving and implementing compliance directives, and supporting quality management systems to minimize risks in a regulated pharmaceutical environment. The role involves conducting and participating in all GXP QA audit programs, including internal and external audits, and providing support to the GXP QA Director across clinical operations, non-clinical, and manufacturing sectors. Responsibilities • Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials., • Plan and conduct audits of specific clinical processes based on risk., • Perform clinical vendor audits along with various subject matter experts to comprehensively assess all services provided by a vendor., • Develop audit reports and distribute them to appropriate stakeholders., • Own and manage related clinical vendor non-conformances., • Review, understand, and audit clinical-related regulations and guidelines (e.g., FDA regulations, GCP, etc.)., • Collaborate with clinical sourcing, supplier quality, and clinical partnership to manage clinical vendors., • Support the preparation, coordination, and participation of regulatory agency inspections., • Participate in and support quality improvement projects.Essential Skills, • 5+ years of pharmaceutical experience., • Bachelor's degree in scientific, healthcare, or related discipline., • Extensive GCP and safety background., • Experience with both internal and external process and systems audits., • Strong knowledge of development policies, procedures, and standards (SOPs, QMS)., • Ability to work with global clinical teams in developing objectives for audits of clinical studies.Additional Skills & Qualifications, • Sponsor experience, not only CRO experience., • 2 years of experience with GCP, TMF audits, system audits, inspection readiness, and CRO audits., • 2 years of experience in independent auditing. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Paramus,NJ. Application Deadline This position is anticipated to close on Feb 27, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job Description About Vitalief Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. Our team combines deep clinical research expertise with results-driven consulting to help organizations operate more efficiently and grow sustainably. The Role We are seeking an experienced IRB Coordinator Consultant to join the Vitalief team as a contractor. In this role, you will support a leading hospital research center in Livingston, NJ, administering and overseeing Institutional Review Board (IRB) activities to ensure compliance with federal, state, and institutional regulations governing human subjects research. This role supports investigators, staff, and IRB members in the preparation, review, and approval of research protocols, while also assisting with Nussbaum grant activities. Engagement Details • Work Hours: 40 hours per week (8am to 4pm M-F), • Work Location: 100% on-site in Livingston, NJ., • Contract Duration: 6 months (possible extension), • Pay Rate: Market competitive (depends on experience level) Responsibilities:, • Under the direction of the Director of Graduate Medical Education and Clinical Research, coordinate and manage all IRB activities, meetings, and communications., • Review protocol submissions for completeness and accuracy; recommend appropriate level of review., • Draft and issue correspondence reflecting IRB deliberations and decisions., • Provide regulatory and methodological guidance to investigators, staff, students, and IRB members., • Maintain compliance with OHRP, FDA, ICH/GCP, and institutional regulations., • Manage IRB databases, tracking systems, and protocol documentation., • Assist with emergency use protocols and special meetings as needed., • Schedule and support Institutional Research Committee meetings, prepare agendas/minutes, and follow up on action items., • Collaborate with other system IRB Coordinators and departmental staff., • Bachelor’s degree in a scientific or health-related field required; Master’s degree preferred., • Three (3) years of experience in clinical research and research administration, including two (2) years of IRB operations experience., • Strong understanding of IRB regulations, ethical research standards, and ICH/GCP guidelines., • Excellent written and verbal communication skills., • Ability to demonstrate professionalism, clear communication, and respect in all interactions., • Passionate in supporting teamwork and collaborative problem-solving., • Apply continuous quality improvement principles to research operations., • Work independently with accountability, sound judgment, and openness to feedback., • Strong organizational and time management abilities; must be self-motivated and able to multi-task on a variety of projects., • Detail-oriented with strong organizational and follow-up skills., • Proficiency with Microsoft Office (Word, Excel, PowerPoint); database management experience preferred., • Certified IRB Professional (CIP®) is a plus., • Knowledge of medical terminology preferred. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. #LI-DNP Powered by JazzHR lfKp3BPFdR

Job DescriptionJOB DESCRIPTION:The GCP Quality Assurance Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company’s compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day-to-day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials. The Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience. This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies. They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance RESPONSIBILITIES:Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials. Plan and conduct audits of specific clinical processes based on risk. Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor. Develop audit reports and distribute them to appropriate stakeholders. Own and manage related clinical vendor non-conformances. Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.). Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors. Support the preparation, coordination, and participation of regulatory agency inspections. Participate in and support quality improvement projects. QUALIFICATIONS:5+ years of pharmaceutical experience 2+ years of RadioPharmaceutical and Quality Assurance experience BS degree in scientific, health care or related discipline Intensive GCP and safety background Experience with both internal and external process and systems audits Strong knowledge of development policies, procedures and standards (SOPs, QMS) Ability to work with global clinical teams in developing objectives for audits of clinical studies 10% Traveling required

Job DescriptionJob Title: GCP Auditor/Senior Auditor, Quality AssuranceJob Description This position focuses on ensuring GXP compliance with regulatory authorities, driving and implementing compliance directives, and supporting quality management systems to minimize risks in a regulated pharmaceutical environment. The role involves conducting and participating in all GXP QA audit programs, including internal and external audits, and providing support to the GXP QA Director across clinical operations, non-clinical, and manufacturing sectors. Responsibilities • Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials., • Plan and conduct audits of specific clinical processes based on risk., • Perform clinical vendor audits along with various subject matter experts to comprehensively assess all services provided by a vendor., • Develop audit reports and distribute them to appropriate stakeholders., • Own and manage related clinical vendor non-conformances., • Review, understand, and audit clinical-related regulations and guidelines (e.g., FDA regulations, GCP, etc.)., • Collaborate with clinical sourcing, supplier quality, and clinical partnership to manage clinical vendors., • Support the preparation, coordination, and participation of regulatory agency inspections., • Participate in and support quality improvement projects.Essential Skills, • 5+ years of pharmaceutical experience., • Bachelor's degree in scientific, healthcare, or related discipline., • Extensive GCP and safety background., • Experience with both internal and external process and systems audits., • Strong knowledge of development policies, procedures, and standards (SOPs, QMS)., • Ability to work with global clinical teams in developing objectives for audits of clinical studies.Additional Skills & Qualifications, • Sponsor experience, not only CRO experience., • 2 years of experience with GCP, TMF audits, system audits, inspection readiness, and CRO audits., • 2 years of experience in independent auditing. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Paramus,NJ. Application Deadline This position is anticipated to close on Feb 27, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job DescriptionJob Title: GCP Auditor/Senior Auditor, Quality AssuranceJob Description This position focuses on ensuring GXP compliance with regulatory authorities, driving and implementing compliance directives, and supporting quality management systems to minimize risks in a regulated pharmaceutical environment. The role involves conducting and participating in all GXP QA audit programs, including internal and external audits, and providing support to the GXP QA Director across clinical operations, non-clinical, and manufacturing sectors. Responsibilities • Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials., • Plan and conduct audits of specific clinical processes based on risk., • Perform clinical vendor audits along with various subject matter experts to comprehensively assess all services provided by a vendor., • Develop audit reports and distribute them to appropriate stakeholders., • Own and manage related clinical vendor non-conformances., • Review, understand, and audit clinical-related regulations and guidelines (e.g., FDA regulations, GCP, etc.)., • Collaborate with clinical sourcing, supplier quality, and clinical partnership to manage clinical vendors., • Support the preparation, coordination, and participation of regulatory agency inspections., • Participate in and support quality improvement projects.Essential Skills, • 5+ years of pharmaceutical experience., • Bachelor's degree in scientific, healthcare, or related discipline., • Extensive GCP and safety background., • Experience with both internal and external process and systems audits., • Strong knowledge of development policies, procedures, and standards (SOPs, QMS)., • Ability to work with global clinical teams in developing objectives for audits of clinical studies.Additional Skills & Qualifications, • Sponsor experience, not only CRO experience., • 2 years of experience with GCP, TMF audits, system audits, inspection readiness, and CRO audits., • 2 years of experience in independent auditing. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Paramus,NJ. Application Deadline This position is anticipated to close on Feb 27, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Hackensack Meridian Health is seeking a Nephrology Transplant Physician Scientist to join our prestigious Center for Discovery and Innovation (CDI) and the Division of Organ Transplantation at Hackensack University Medical Center. This unique dual-role position combines cutting-edge basic and translational transplant/immunology research with clinical excellence in nephrology, caring for pre- and post-renal transplant patients and living kidney donors. The physician scientist will serve as a key member of our multidisciplinary transplant team alongside physicians, coordinators, administrators, and specialized support staff. Scientific Responsibilities – Assistant Member, HMH Center for Discovery & Innovation • Conduct impactful basic or translational research in transplant/immunology., • Pursue grant funding and philanthropic support to sustain laboratory operations., • Lead and oversee laboratory processes, research staff, budgeting, and financial management., • Establish strategic research goals aligned with the clinical goals of the Division of Organ Transplantation., • Hold regular oversight meetings with the Chief Scientific Officer and Director of Transplantation., • Develop and implement laboratory policies, procedures, and personnel decisions., • Mentor and evaluate lab staff performance., • Participate in professional activities, including consulting, editorial work, training, study sections, seminars, and national/international conferences. Clinical Responsibilities – Attending Nephrologist, Division of Organ Transplantation • Evaluate potential living donor and transplant recipient candidates., • Provide inpatient and outpatient care for pre- and post-transplant donors and recipients., • Teach fellows, residents, nurses, students, and multidisciplinary staff., • Collaborate to ensure full compliance with all regulatory standards., • Participate in policy development, research initiatives, and departmental protocols., • Serve as a resource and representative for organ donation and transplantation at institutional and community events., • Engage regularly with hospital personnel, patients, and visitors. Education & Experience: • MD or equivalent foreign degree., • Completion of an Internal Medicine Residency and Transplant Fellowship, • Consideration for applicants with strong transplant experience during/after a Nephrology Fellowship., • Minimum 3 years in a funded research program., • Demonstrated success securing NIH and/or foundation funding., • Peer-review experience (manuscripts, grants, editorial boards, or review committees)., • Minimum of 15 scientific publications, with majority as first or last author. Licensure & Certification: • Board Certified in Internal Medicine., • Board Certified or Board Eligible in Nephrology., • Eligible for New Jersey Medical License. HOW TO APPLY: Submit Cover Letter and CV for immediate consideration to: Nancy Massa, Physician Recruiter Email: Phone: 732-890-9339 (Call or Text) HMH is committed to pay equity and transparency for our team members. The minimum base salary for this position is $316,154. The posted rate of pay in this job posting is a reasonable good-faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package. The starting rate of pay is provided for informational purposes only and is not a guarantee of a specific offer. Posted hourly rates may be stated as an annual salary in the offer and posted annual salaries may be stated as an hourly rate in the offer, depending on the level and nature of the job duties and credentials of the candidate. The base compensation determined at the time of the offer may be different than the posted rate of pay based on a number of non-discriminatory factors, including but not limited to: Labor Market Data: Compensation is benchmarked against market data to ensure competitiveness. Experience: Years of relevant work experience. Education and Certifications: Level of education attained, including specialized certifications, credentials, completed apprenticeship programs or advanced training. Skills: Demonstrated proficiency in relevant skills and competencies. Geographic Location: Cost of living and market rates for the specific location. Internal Equity: Compensation is determined in a manner consistent with compensation ranges for similar roles within the organization. Budget and Grant Funding: Departmental budgets and any grant funding associated with the job position may impact the pay that can be offered. Some jobs may also be eligible for performance-based incentives, bonuses, or commissions not reflected in the starting rate. Certain positions may also be eligible for shift differentials for work performed on evening, night, or weekend shifts. In addition to our compensation for full-time and part-time (20+ hours/week) job positions, HMH offers a comprehensive benefits package, including health, dental, vision, paid leave, tuition reimbursement, and retirement benefits.