- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable ... SM) and relevant external stakeholders. The role will manage and or support medical affairs Quality resources (US, Brazil, Japan/ APAC and EU):in an efficient… more
- Merck & Co. (Rahway, NJ)
- …Capabilities, Quality Assurance , Technical Operations, and CMC Regulatory Affairs , to address technical challenges, provide scientifically sound guidance ... field with 3 years of relevant experience in analytical development, validation, and/or quality control, or MS degree .-- - - Experience and Skills -- Required… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in relevant training programs.Provide mentorship and guidance to RD PV QA on quality assurance practices and regulatory compliance.Keep abreast of evolving ... properly investigated and that technology-related audits are conducted.Oversee and guide quality assurance processes related to project specifications, ensuring… more
- Tris Pharma (Monmouth Junction, NJ)
- …medical writing guidance and supports cross-functional teams (ie, clinical development, regulatory affairs , biostatistics, external vendors, etc.) Oversees, and ... and templates (ie, EndNote, Starting Point, etc.)Experience with data management and quality assurance processesWe are a HYBRID work environment requiring… more
- Actalent (Piscataway, NJ)
- Job Title: Quality Assurance and Regulatory Affairs SpecialistJob Description As a Quality Assurance and Regulatory Affairs Specialist, ... as a team, and transcending what is possible. + Support Regulatory Affairs and Quality Assurance management as needed. + Perform all other duties as… more
- Bayer (Whippany, NJ)
- …Product Development, as well as executives in Marketing, Sales, Manufacturing, Drug Safety, Quality Assurance , Regulatory Affairs and Legal Departments; ... identified and shared with key internal stakeholders; + Assists in any designated quality assurance review program. Ensures that information systems used by… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …development products by closely working with MTP internal colleagues in various functions ( Quality Assurance , Regulatory Affairs , Marketing, Market ... + Collaborates effectively with colleagues in Supply Chain, Accounting, Market Access, Quality Assurance , Regulatory Affairs , Finance, etc. of Mitsubishi… more
- Integra LifeSciences (Princeton, NJ)
- …manufacturing. **Cross-Functional Collaboration:** + Collaborate closely with cross-functional teams (eg, quality assurance , regulatory affairs , R&D, ... projects, and work cross-functionally. + Detail-oriented with a commitment to maintaining high- quality standards and regulatory compliance. + Experience with … more
- J&J Family of Companies (Raritan, NJ)
- …continuous improvement. **Stakeholder Collaboration:** + Work closely with cross-functional teams, including Quality Assurance , Regulatory Affairs , and ... compliance frameworks. **Data Management:** + Establish protocols for data integrity, quality assurance , and validation to support compliance objectives. +… more
- Stryker (Mahwah, NJ)
- We are currently seeking a **Senior Manager, Regulatory Affairs ** to join our Joint Replacement Division (Mako and Enabling Technologies Business Unit). Ideally, ... FL with some workplace flexibility. As the **Senior Manager, Regulatory Affairs ** , you will lead and...labeling, and marketing materials + Communicate and collaborate with Quality Assurance , R&D, Service, Global Supply, Finance,… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational...quality assurance , etc.) in pharmaceutical or healthcare… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **JOB SUMMARY** The Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to ... SM) and relevant external stakeholders. The role will manage and or support medical affairs Quality resources (US, Brazil, Japan/ APAC and EU):in an efficient… more
- Bausch + Lomb (Trenton, NJ)
- …B&L departments (eg, R&D/Project Management, Clinical/Medical Affairs , Biometrics, Regulatory Affairs , Quality Assurance , Pharmacovigilance/GPSS ... ICH, GCP and B&L SOPs. + Responsible for the quality of all study-related documentation (eg, Trial Master File,...timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house… more
- System One (Florham Park, NJ)
- …electronic submissions. + Coordinate with cross-functional teams, including Regulatory Affairs , Clinical Development, and Quality Assurance , to obtain ... work collaboratively with cross-functional teams, including regulatory affairs , clinical operations, and quality assurance... regulatory affairs , clinical operations, and quality assurance in a team-oriented environment. +… more
- TD Bank (Mount Laurel, NJ)
- …complete, consistent, and high- quality communications; ensuring centralized awareness and quality assurance for all regulatory requests and responses ... the SVP of Regulatory Operations and the Head of Regulatory Relationships and Government Affairs . + Meets regularly with RPM team members to obtain status… more
- Merck (Rahway, NJ)
- …Capabilities, Quality Assurance , Technical Operations, and CMC Regulatory Affairs , to address technical challenges, provide scientifically sound guidance ... field with 3 years of relevant experience in analytical development, validation, and/or quality control, or MS degree. **Experience and Skills** Required + At least… more
- Unilever (Englewood Cliffs, NJ)
- …cross functional team of marketing, customer development, supply chain, research and development, regulatory affairs , quality assurance , and human ... resources across all markets. This role will report into the Wellbeing CFO . Given the dynamic, fast-paced nature of Wellbeing International, the ideal candidate should be comfortable serving as a generalist who can work in changing environments with limited… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …in relevant training programs. + Provide mentorship and guidance to RD PV QA on quality assurance practices and regulatory compliance. + Keep abreast of ... and that technology-related audits are conducted. + Oversee and guide quality assurance processes related to project specifications, ensuring standard… more
- Sanofi Group (Morristown, NJ)
- …+ Collaborate with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial to align ... that leverage digital technologies for advanced research opportunities. **Compliance and Quality Assurance ** + Accountable for ensuring all evidence generation… more
- J&J Family of Companies (Titusville, NJ)
- …regulatory filings. Team matrix interactions include project management, finance, legal, quality assurance , quality monitoring & compliance, clinical ... supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global medical affairs , clinical pharmacology, clinical… more
