- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of employee and/or contractor-based staff/analysts to support the overall delivery of a clinical trial diversity and patient access strategy. Qualifications: ... mechanisms at the study team and clinical trial site level to proactively monitor diversity ...experience required Experience Qualifications.7 or More Years 7 years clinical operations experience in trial diversity… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …investigators is expected. The CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical ... Innovation 110 Years and Counting! Company is committed to diversity and inclusion. We are an equal opportunity employer...Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …meetings Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director , and Field Medical Affairs point to ... for select clinical trials, in collaboration with Clinical Director and Clinical Operations...Medical Affairs team on relevant disease state topics and clinical trial data. Review and approve resources… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development, ... pipeline.Proactively identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial lifecycle.Standardize… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external partners, identify, qualify, manage, and maintain relations with clinical trial sites, including collaboration with PIs and patient ... advanced degree is preferred A minimum of 12 years' progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO and/or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …medicinal product dossiers (IMPD), investigational new drug applications (IND), clinical trial applications (CTA), marketing authorization applications (MAA), ... clinical development and regulatory requirements of a clinical program. The Director will provide high...committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D ... in the unique opportunity to bring highly innovative pharmaceutical products through clinical development to market. The candidate is a team player, detail oriented… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …degree preferred A minimum of ten (10) years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, or CRO required, ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...processes (ie automation, technology, process optimization). Relationships Reports to Director or above within CMR Training & Knowledge Management.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decisions (phase I trials) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure ... Relationships This position will report to Senior Global Safety Lead/ Director /Senior Director - Safety Surveillance, US East...Responsible for all areas related to patient safety in clinical trials Act as member of the trial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reports (CSR) Investigator brochures (IB) Informed consent and assent forms Lay summaries of clinical trial results Clinical evaluation plans (CEP) and ... program. Relationships The Senior Medical Writer reports to a Director of Medical Writing. The Senior Medical Writer is...to detail to ensure the accuracy and consistency of clinical trial documents A strong foundation in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …is preferred A minimum of eight (8) years of progressively responsible clinical development/ trial experience within a pharmaceutical, biotechnology, or CRO ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...share resources across multiple groups. Relationships Reports to Associate Director or above within CMR Training & Knowledge Management.… more
- Novo Nordisk (Plainsboro, NJ)
- …+ Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director , and Field Medical Affairs point to ... for select clinical trials, in collaboration with Clinical Director and Clinical Operations...Medical Affairs team on relevant disease state topics and clinical trial data. Review and approve resources… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & ... the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses &… more
- Novo Nordisk (Plainsboro, NJ)
- …medicinal product dossiers (IMPD), investigational new drug applications (IND), clinical trial applications (CTA), marketing authorization applications (MAA), ... clinical development and regulatory requirements of a clinical program. The Director will provide high...committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and… more
- The Mount Sinai Health System (New York, NY)
- …* Supportive and experienced clinical staff * State of the art clinical trial unit, clinical and translational research environment and affiliated ... Icahn School of Medicine at Mount Sinai seeks a Director for its Skin of Color Center in Manhattan!**...with a strong academic record of accomplishments and/or academic, clinical and research productivity, impressive publications and a deep… more
- Novo Nordisk (Plainsboro, NJ)
- …area, help develop PRO and biomarker strategies. Relationships Reports to: Senior Medical Director Work with the Clinical Operations, Non- Clinical Research, ... NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating...ready to make a difference? The Position The Medical Director serves as the subject matter expert for our… more
- Gilead Sciences, Inc. (Toms River, NJ)
- …timelines. This may include, but is not limited to, providing statistical consultation on clinical development plans, clinical trial design and clinical ... + Reviews and analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring. + Uses a variety of advanced statistical software,… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …and brings the same high level of expertise, clinical care, and access to clinical trial protocols that are available at our main campus in New York City. ... of America's Best Employers For Diversity (https://mskcc.sharepoint.com/sites/pub-DiversityInclusion/SitePages/MSK-Ranks-in-Top-20-on-Forbes%E2%80%99-list-of-America%E2%80%99s-Best-Employers-For- Diversity .aspx) ). The largest of MSK's clinical… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of ... has robust and wide-ranging research activities involving prospective and retrospective clinical and translational studies that examine the role of radiation in… more
- Publicis Groupe (New York, NY)
- …agencies specializing in promoting innovative solutions in advertising, medical education, clinical trial program development, sales and marketing, digital, ... curiosity, determination, and creativity to our client work. We're seeking a Director , Technical Project Manager to support the successful delivery of complex tech… more
