- Merck & Co. (Rahway, NJ)
- …is part of our company's Social Business Innovation (SBI) department within Corporate Affairs . The ESG team works cross-functionally with senior leaders and ... and healthy future for people and communities everywhere.The role of Associate Director , ESG Strategic Reporting is a unique opportunity to join our company… more
- Merck & Co. (Rahway, NJ)
- …placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre-clinical and ... with talented and dedicated colleagues while developing and expanding your career.The Senior Director ( Senior Principal Scientist) has primary responsibility… more
- Merck & Co. (Rahway, NJ)
- …studies;Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriateness throughout the product's lifecycle and across different indications.Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... Years Experience in the pharmaceutical industry7 or more years with direct regulatory affairs experienceExperience in regulatory submissions in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research, translational biomarkers, companion diagnostics, bioinformatics, clinical development, medical affairs , regulatory etc.).Identify and interact with key ... will interact with the Companion Diagnostics Lead, Non-Clinical Research, Medical Affairs and other stakeholders to support the program. Other responsibilities will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of ... at key governance meetings whereby GCLP/GLP activities are being discussed ( Regulatory affairs , Research unit LT, GRDC etc.,) Effectively interacts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) ... collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director / Senior Director , Clinical Quality Assurance. This is a hybrid ... Title commensurate with experience.SUMMARY:Reporting to the Chief Quality Officer the Senior Director of Clinical Quality Assurance provides strategic leadership… more
- Tris Pharma (Monmouth Junction, NJ)
- …to hear from you.We are hiring at our Monmouth Junction NJ Headquarters for a Senior Director to lead our small, but productive, Marketing team.The Senior ... compliant communication between marketing and other cross-functional teams (ie, Medical Affairs , Sales, Regulatory Affairs , Operations, etc.)Collaborates… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …diseases, researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), ... practical, workable plans to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical also works directly… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... in the pharmaceutical industry + 7 or More Years with direct regulatory affairs experience, including experience in regulatory submissions in Oncology +… more
- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head, ... GRS, is responsible for the management of global regulatory leads with product and disease state expertise for specific therapeutic area(s). Provides oversight for… more
- Mount Sinai Health System (New York, NY)
- …CMO - MSH, Mount Sinai Hospital **Responsibilities** In collaboration with Senior Director of Regulatory Affairs , and other system leadership, directs ... **Job Description** A member of MSHS regulatory team, the Accreditation Specialist is a key...leader and participant in the systems continuous accreditation and regulatory readiness program. Responsible for providing direction and oversight… more
- New York State Energy Research and Development Aut (New York, NY)
- … attorney (the "MD-L&R") to join its management team, lead its Legal & Regulatory Affairs ("LRA") team and provide legal advice and strategic counsel with ... being directly responsible for a variety of legal and regulatory affairs activities and deliverables at the...the MD-L&R participates, along with the rest of NYGB's senior team, in formulating and implementing the strategy and… more
- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs , Strategic Labeling is responsible for ... or Microbiology + Preferred Education: Relevant Master's degree preferred. Certification in regulatory affairs a plus + Required Experience: 10+ years… more
- Mount Sinai Health System (New York, NY)
- …oversight of major regulatory programs as defined and agreed upon with the Senior Director of the Clinical Trial Operations and the Principal Investigator of ... faculty. InCHOIR faculty are expert in study design, clinical coordination, regulatory approval and management, endpoint and event adjudication and Data Safety… more
- System One (Florham Park, NJ)
- Senior Manager, Regulatory Affairs ...Life (QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory ... days onsite) 12-month contract (renewable) Overview The Contractor - Senior Manager, Regulatory Affairs -...QOL initiatives. Responsibilities + Support the Senior Director in developing and executing regional regulatory … more
- LS Power Development, LLC (East Brunswick, NJ)
- …parental leave and more. **About the Role:** We currently have an opportunity for a Manager/ Director of Government Affairs that can be based in our New Jersey or ... and advocacy strategies.As a member of LS Power's government affairs team, you will be responsible for designing and...are clearly aligned with business + Communicate legislative and regulatory strategies clearly to senior and executive… more
