9 jobs found in Paramus, NJ

GMP Sr. Auditor Paramus, NJ  If you post this job on a job board, please do not use company name or salary.  Experience level: Mid-senior Experience required: 5 Years Education level: Bachelor’s degree Job function: Accounting/Auditing Industry: Pharmaceuticals Pay rate : View hourly payrate Total position: 1 Relocation assistance: No Visa sponsorship eligibility: No Job Summary: The RPT QA Auditor is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with cGMP, regulatory requirements, and company quality standards. This role supports the Pharmaceutical Quality System (PQS) by identifying gaps, recommending corrective actions, and driving continuous improvement across manufacturing, testing, and distribution processes.   Key Responsibilities: Conduct routine, for-cause, and risk-based audits of internal processes, RPT CMOs, and suppliers. Prepare detailed audit plans, checklists, and...

GCP Sr. Auditor Paramus, NJ   GCP Sr. Auditor Paramus, NJ Experience level: Mid-senior Experience required: 5 Years Education level: Bachelor’s degree Job function: Accounting/Auditing Industry: Pharmaceuticals Pay rate : View hourly payrate Total position: 1 Relocation assistance: No Visa sponsorship eligibility: No JOB 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...

Clinical Supplies Manager Paramus, NJ   Experience level:  Mid-senior   Experience required:  8 Years   Education level:  Bachelor’s degree   Job function:  Management   Industry:  Pharmaceuticals   Pay rate :   View hourly payrate   Total position:  1   Relocation assistance:  No   Visa sponsorship eligibility:  No   SUMMARY OF POSITION: Assist and support the Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Clinical Supplies. Review master batch records (MBR), Master Packaging Work Orders (MPWO), and clinical related supplies-related documents. Assist and support the review of packaging, labeling, storage, logistics, and distribution documentation of the investigational product. Assist and support the management of clinical supply inventories using...

GCP Sr. Auditor  Paramus, NJ GCP Sr. Auditor, GCP, Auditor, Pharmaceutical, Audits, SOPs, QMS, GXP QA audit programs, GXP Compliance, GXP, Clinical Vendor Audits,    Experience level: Mid-senior Experience required: 5 Years Education level: Bachelor’s degree Job function: Accounting/Auditing Industry: Pharmaceuticals Pay rate : View hourly payrate Total position: 1 Relocation assistance: No JOB 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...

 CMC Writer Paramus, NJ CMC Writer, Chemistry, Manufacturing, and Controls, Regulatory, Drug Development, Manufacturing, and Quality Control, NDA/MAA CTD, EU (IMPD and MAA), US-FDA, FDA, IND, BLA, NDA, eCTD, Project Management, Pharmaceutical  If you post this job on a job board, please do not use company name or salary.  Experience level: Mid-senior Education level: Bachelor’s degree Job function: Health Care Provider Industry: Pharmaceuticals Pay rate : $49 per hour  Total position: 1 Relocation assistance: No Visa sponsorship eligibility: No SUMMARY: A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in regulatory submissions by preparing technical documents related to drug development, manufacturing, and quality control. JOB DESCRIPTION: Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing...

Sr. Principal Statistics  Paramus, NJ    Experience level:  Mid-senior   Experience required:  6 Years   Education level:  Doctorate   Job function:  Management   Industry:  Pharmaceuticals       Total position:  1   Relocation assistance:  No   Visa sponsorship eligibility:  No   JOB DESCRIPTION: The Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing. RESPONSIBILITIES: Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc. Review CRF, database design, and edit check specs Review study quality...

Business Analyst with Healthcare Domain   Hackensack, NJ Experience: 12 Years Duration    :  Long term Contract   Need LinkedIn & Passport No with the profile   MANDATOR SKILLS: HEALTHCARE DOMAIN, EHR/EMR systems, healthcare interoperability standards,    HIPAA, HITECH, CMS   Job Description: - Working across functional areas. Demonstrating expertise in clinical electronic information systems for data extraction and reporting. Interpreting business data, analyzing results using statistical techniques, and providing ongoing reports. Collaborating with the Clinical Intelligence and IT teams, as well as subject matter experts, to define reporting solutions. Facilitating project groups in developing survey tools, metrics, dashboards, reports, and oncology monitoring plans with an analytical and statistical focus. Critically evaluating information gathered from...

Human Resource Manager Hackensack, NJ Type Direct Hire Salary $100,000 - $120,000 / yr We are seeking an experienced and knowledgeable Human Resources Manager to join our team. As the Human Resources Manager, you will be responsible for overseeing all aspects of the HR department, including recruitment, employee relations, performance management, benefits administration, and compliance with employment labor laws. This is a senior leadership role that requires strong interpersonal skills and the ability to effectively communicate with employees at all levels of the organization. Duties: - Develop and implement HR policies and procedures in accordance with company goals and applicable employment labor laws - Manage the recruitment process, including sourcing candidates, conducting interviews, and making hiring decisions - Oversee employee onboarding and orientation programs to ensure a smooth transition for new hires - Administer performance management programs, including...

Endocrinologist  Yonkers, NY she   Salary: $215k-415k   We are is seeking a Board-Certified or Board-Eligible Endocrinologist to join a multidisciplinary team of experts dedicated to providing exceptional patient-centered care. This position offers a unique opportunity to work in a collaborative environment with access to cutting-edge treatments and resources to help patients manage a wide range of endocrine disorders. Position Highlights: Diagnose and manage a broad spectrum of endocrine disorders, including diabetes, thyroid disease, osteoporosis, adrenal and pituitary conditions, and metabolic disorders Develop personalized treatment plans integrating medication, lifestyle changes, and dietary guidance Utilize advanced diagnostic tools and imaging to assess hormone levels and gland function Work closely with a multidisciplinary team, including nurse practitioners, dietitians, and other specialists Educate and counsel patients on long-term disease...