- 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
- Merck (Rahway, NJ)
- …The GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. ... + Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that...the organization, including managing the impact of final external regulatory policies that support work that is executed in… 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
- Merck (Rahway, NJ)
- **Job Description** **Position Title** - Principal Scientist **Department** - Global Regulatory Affairs and Clinical Safety - Vaccine & Infectious Disease ... global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. + Develops… more
- Merck (Rahway, NJ)
- …and solutions to the world. **Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:** + Developing ... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety...but are not limited to:** + Reports to Executive Director or Associate Vice President, Therapeutic Area Lead. +… 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …within the Inflammation TA. You will work closely with the Inflammation Fibrosis Regulatory Affairs (RA) Franchise Lead, Regional Regulatory Liaisons and ... regulatory strategy. + Provide strategic guidance as the Regulatory Affairs Inflammation subject matter expert on cross-functional/cross-regional sub-teams… more
- Bristol Myers Squibb (Madison, NJ)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... the stages of team development. + Experience with developing regulatory strategies in coordination with clinical plans...with developing regulatory strategies in coordination with clinical plans and marketing objectives. + Experience with … 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
- The Mount Sinai Health System (New York, NY)
- …with an interdisciplinary faculty. InCHOIR faculty are expert in study design, clinical coordination, regulatory approval and management, endpoint and event ... and industry funding. This position is responsible for translating regulatory knowledge relating to human research, including federal, state,...programs as defined and agreed upon with the Senior Director of the Clinical Trial Operations and… 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
- 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
- Danaher Corporation (New York, NY)
- …Medical & Scientific Affairs Innovation Team and report to the Sr. Director , Medical & Scientific Affairs , Innovation responsible for redefining the role of ... clinical guidance to key stakeholders internally (R&D, product management, clinical , regulatory ) and externally. + Support critical innovation initiatives by… 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)
- … team, Pfizer country medical teams, and colleagues in Global Medical Affairs , Vaccine Research and Development, Regulatory , Commercial, Public Affairs ... issues and provide information/data to support internal staff working on commercial, regulatory , and medical affairs planning + Participate in the Epidemiology… more
- Pfizer (New York, NY)
- **ROLE SUMMARY** As theSenior Medical Affairs Director , you will play a pivotal role in shaping equitable patient access to quality medicines and vaccines. Acts ... standpoint points of view. + Work closely with cross functional teams (Marketing, regulatory , public affairs , legal, compliance, and Global Access & Value) to… more
- Pfizer (New York, NY)
- …program regulatory inspections and audits. In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, ... consultants, KOL and potentially regulatory meetings. + Represents TA Clinical Affairs and may take the lead on company-wide, global process improvement… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …(ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Director , Clinical Development will provide ... such as commercial, regulatory , pharmacovigilance, CMC, early clinical and pre- clinical development in this regard. The Director will be a key… more