- Mitsubishi Chemical Group (Jersey City, NJ)
- …real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called upon to ... facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical also works directly with cross-functional project… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ... requests, meeting requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including external contractors (eg,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As a Director , Global Regulatory Affairs , Precision Medicine you will ... need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and...clinical studies. You will provide operational and technical regulatory assistance through all stages of clinical … more
- Merck (Rahway, NJ)
- …Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... **Job Description** Our Regulatory Affairs team bring new medical...someone with a growth mindset. **Position Description:** The Senior Director , Global Regulatory Lead, is responsible for… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for content development, ... compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New… more
- AbbVie (Florham Park, NJ)
- …scientific and medical expertise to cross-functional teams, including research and development, regulatory affairs , market access, and commercial teams. + Ensure ... level will be determined by the qualifications listed below. The Medical/Scientific Director , Medical Affairs - Psychiatry Pipeline is a strategic scientific… more
- AbbVie (Florham Park, NJ)
- …can sit in our Lake County, IL or Madison, NJ offices. The Scientific Director for US Medical Affairs in CNS/Psychiatry provides specialist medical and ... medical data and information across study protocols, Investigator Brochures, Clinical Study Reports, publications/presentations and regulatory submissions and… more
- Bristol Myers Squibb (Madison, NJ)
- …in close partnership with the US Commercialization organization, WW Medical, Clinical Research and Development, Regulatory , Translational Development, and Market ... interpretation. + Excellent analytical skills and solid experience in translating medical/ clinical information into medical affairs strategies. + Excellent oral… more
- AbbVie (Florham Park, NJ)
- …PharmD. Additional post doctorate experience highly preferred. + Knowledge of clinical trial methodology, data analysis and interpretation, regulatory ... global business strategy. + Proven ability to run a clinical study or medical affairs cross-functional team...4+ years of experience is preferred. Qualifications for Scientific Director + Typically, 10-15 years of experience in the… more
- AbbVie (Florham Park, NJ)
- …medical, scientific, strategic and operational leadership and expertise into core medical affairs activities such as: generation of clinical and scientific data) ... and reporting of scientific content of study protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses. +… more
- AbbVie (Florham Park, NJ)
- …(promotional material generation and product launches) and market access. Collaborates with clinical development on Medical Affairs support of priority trials. ... Affairs initiatives for the target indication. + Develops and executes Medical Affairs support of priority clinical development trials. + Contributes to the… more
- Pfizer (New York, NY)
- …extensive pipeline of over 50 programs in clinical development. + The Medical Affairs AI Innovation Director will report into the Oncology AI Innovation Head ... as an operational business partner across Oncology Medical, International Medical Affairs and Pfizer US (Medical Platforms) for all Artificial Intelligence (AI)… more
- Pfizer (New York, NY)
- …program regulatory inspections and audits. In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents ... consultants, KOL and potentially regulatory meetings. + Represents Vaccine Clinical Affairs and may take the lead on company-wide, global process improvement… more
- Veterans Affairs, Veterans Health Administration (Bronx, NY)
- …the Commission on Accreditation of Rehabilitation Facilities (CARF), and other regulatory and accrediting agency standards. Creates and monitors systems to ensure ... Develops policies, processes, and procedures that address all VA, Federal, regulatory , and accrediting requirements for HIM. Evaluates health records program and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …RADICAVA(R) (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , and business development ... evidence, and creating hope for all facing illness. The Director , Clinical Science (I&I) will lead the...and MAA for the company, drawing on expertise in clinical and regulatory strategy and requirements, both… more
- Bristol Myers Squibb (Madison, NJ)
- …Ph.D., MD, PharmD, MS, or BS **Experience Requirements** Significant experience in regulatory affairs (eg > 4-7 years) **Key Competency Requirements** Required: ... global submission plans and Health Authority interaction plans. + Provide strategic regulatory input to key development documents, including clinical protocols, … more
- Bristol Myers Squibb (Madison, NJ)
- …MS or commensurate experience preferred **Experience Requirements** Significant experience in regulatory affairs (eg 3-5 years) **Key Competency Requirements** ... careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products in development and through life… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …PK analysis plans, study reports, and Clinical Pharmacology sections of regulatory submissions. The Senior Director , Clinical Pharmacology also analyzes, ... (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , and...and creating hope for all facing illness. The Senior Director , Clinical Pharmacology supports the company's … more
- Merck (Rahway, NJ)
- …monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior Clinical Director May Be Responsible For:** + Evaluating pre- clinical ... **Job Description** The **Senior Clinical Director (Sr. Principal Scientist)** has...cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …RADICAVA(R) (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , and business development ... for all facing illness. As a senior member of Clinical Operations, the Senior Director , Clinical... milestones for the company, drawing on expertise in clinical and regulatory requirements, both local and… more