- Merck & Co. (Rahway, NJ)
- …learn new processes and technologies. Broad knowledge of Clinical Development and Regulatory Affairs requirements. The ability to multi-task, work independently, ... and communicate effectively. Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11. #EligibleforERP #ONEGDMSNOTICE FOR INTERNAL APPLICANTSIn accordance with Managers'… more
- Terumo Medical Corporation (Somerset, NJ)
- Regulatory Affairs Specialist Date: Aug 16, 2024 Req ID: 3445 Location: Somerset, NJ, US, 08873 Company: Terumo Medical Corporation Department: Regulatory ... status. + Must make a proactive contribution to the overall Regulatory affairs department growth. + Participates in project performance team meetings on… more
- Englewood Lab, Inc (Totowa, NJ)
- Reports to: Manager of Regulatory Affairs Responsibilities: + Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory ... of the Head of Quality/ Regulatory . + Assist the Manager of Regulatory Affairs during periodic quality reviews, regulatory updates, and annual GMP… more
- Bausch + Lomb (Bridgewater, NJ)
- …* Bachelor's degree preferred or equivalent. * Minimum of 8 years in Regulatory Affairs with experience in the consumer product (Rx/OTC, OTC Monograph, ... business acumen and ability to see the business drivers outside of Regulatory Affairs . * Ability to influence internal and external key stakeholders and KOL.… more
- Bausch + Lomb (Bridgewater, NJ)
- …transfers and geographical expansion projects on behalf of the Global Regulatory Affairs department. **Responsibilities** * Responsible for general knowledge ... Bachelor degree preferred or equivalent * Minimum 1.5 years of Regulatory Affairs Project management experience * PMP Certification preferred Specific Skills: *… more
- The Mount Sinai Health System (New York, NY)
- **JOB DESCRIPTION** The Quality and Regulatory Specialist facilitates and participates in the implementation of the multidisciplinary hospital and system wide ... who coordinates the planning, monitoring and evaluation of the Quality and Regulatory Readiness program. Participates in planned and unplanned regulatory visit… more
- AbbVie (Florham Park, NJ)
- …County, IL or Madison, NJ offices. The Scientific Director for US Medical Affairs in CNS/Psychiatry provides specialist medical and scientific strategic and ... operational input into core medical affairs activities such as: health-care professional and provider interactions; evidence generation of clinical and scientific… more
- AbbVie (Florham Park, NJ)
- …in Florham Park, NJ preferred. Will consider remote candidates. Purpose Provides specialist medical and scientific strategic and operational input into core medical ... affairs activities such as: healthcare professional/provider interactions (HCPs, Patients...into and influences the development of asset strategy. Provides specialist medical insights, and executes on data generation, communication,… more
- Bausch + Lomb (Bridgewater, NJ)
- …to meet regulations. + Leads meetings and discussions with cross-functional teams ( Regulatory Affairs , Medical Affairs , Engineering, Quality, Legal, ... as assigned. **Requirements** **TECHNICAL COMPETENCIES:** Knowledge of medical device regulatory affairs discipline throughout the product lifecycle including… more
- The Mount Sinai Health System (New York, NY)
- …and licensure surveys. **RESPONSIBILITIES** In collaboration with Senior Director of Regulatory Affairs , and other system leadership, directs and facilitates ... **JOB DESCRIPTION** A member of MSHS regulatory team, the Accreditation Specialist is a key leader and participant in the systems continuous accreditation and … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …documents, and other safety documents prepared for and/or affecting compliance of regulatory submission. The Senior Safety Specialist will facilitate development ... 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business development functions. MTPA is dedicated to… more
- Bausch Health (Bridgewater, NJ)
- …JOB** The Proofreader/SPL Specialist , Labeling is responsible to support US Regulatory Affairs Labeling Leads with labeling activities related to development ... accordance with regulations and company process. **KEY ACTIVITIES/RESPONSIBILITIES** Provide Regulatory support in the development, revision, review, and approval of… more
- Edwards Lifesciences (Newark, NJ)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- Bristol Myers Squibb (Summit, NJ)
- …mgmt. and incorporate them into the change management process. + Collaborate with Regulatory Affairs and Quality Assurance teams to ensure that all necessary ... of quality management systems, change control processes, and GMP/GDP regulatory requirements. + Familiarity with conducting quality assessments and implementing… more
- Gentiva (Piscataway, NJ)
- …and compliance required + Registered Nurse required, BSN preferred + Strong regulatory affairs and governance requirements for healthcare + Thorough knowledge ... day. **Overview** We are looking for an **Executive Director Specialist RN** that will travel to many of our...of state and local guidelines that govern regulatory processes for healthcare + Able to travel 100%… more
- Weill Cornell Medical College (New York, NY)
- Title: Academic Program Specialist Location: Upper East Side Org Unit: General Internal Medicine Work Days: Weekly Hours: 35.00 Exemption Status: Non-Exempt Salary ... appointment enrollment packages for candidates, liaises with the Office of Faculty Affairs and Medical Staff Office and follows up to ensure timely submission… more
- Wells Fargo (New York, NY)
- …and site planning, procedures, learning, communications, data, analytics, and reporting. + Regulatory and Policy Affairs (RAPA) is responsible for Wells Fargo ... in Agile methodology + SIE Certifications + CAMS (Certified anti-money laundering specialist ) + CRCM (Certified regulatory compliance manager) + CAFP (Certified… more
- Merck (Rahway, NJ)
- …new processes and technologies. + Broad knowledge of Clinical Development and Regulatory Affairs requirements. + The ability to multi-task, work independently, ... and communicate effectively. + Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11. **\#EligibleforERP** **\#ONEGDMS** **NOTICE FOR INTERNAL APPLICANTS** In accordance… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …the life sciences or other relevant technical area, such as clinical trials, regulatory affairs , or legal clinical trial contracting. 2 Paralegal Certification ... may be desirable. 3 At least 4 years experience in managing research or clinical trial contracts. 4 Integrates active listening, teamwork, and a positive image in pursuit of team goals. 5 Must be a highly motivated self-starter with attention to detail and the… more
- Terumo Medical Corporation (Somerset, NJ)
- …NJ, US, 08873 Company: Terumo Medical Corporation Department: Medical Affairs Operations Terumo Medical Corporation (TMC) develops, manufactures, and markets ... and implementing the clinical advisory vision and strategy in alignment with Medical Affairs and the organization. This role will develop and manage a highly… more
