- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development. Internal relationships include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs, Regulatory Affairs and other ... expert medical community input Regulatory liaison: Write and/or review clinical sections of clinical trial ...committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in a timely fashion. In addition, the SD serves as a key member of the Clinical Trial Strategy Team, provides additional analytic support to the field team, and ... ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to...training initiatives for the medical affairs team Serve on Clinical Trial Strategy Team to identify investigators/sites… 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 ... of 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)
- …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
- 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)
- …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)
- …Development. Internal relationships include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs, Regulatory Affairs and other ... community input + Regulatory liaison: + Write and/or review clinical sections of clinical trial ...committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and… more
- Bristol Myers Squibb (Princeton, NJ)
- …Articulating clinical development strategy + Analyzing, interpreting, and acting on clinical trial data towards development + Serving as principal functional ... or industry setting including education where applicable + Extensive experience in clinical trial design and execution, biomarker development, and development… more
- Bristol Myers Squibb (Princeton, NJ)
- …Articulating clinical development strategy + Analyzing, interpreting, and acting on clinical trial data to support development + Serving as principal ... in their personal lives. Read more: careers.bms.com/working-with-us . The Director will be the clinical lead to...talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared… more
- Novo Nordisk (Princeton, 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 Associate Director will provide...Informed consent and assent forms + Lay summaries of clinical trial results + Clinical … more
- Bristol Myers Squibb (Princeton, NJ)
- …on major markets and key assets; adjust communications plans in accordance with clinical trial results/milestones and changes in the market healthcare landscape ... Professional (CMPP), and ISMPP active member highly desired + Understanding of clinical trial design and execution, statistical methods and clinical… more
- Bristol Myers Squibb (Princeton, NJ)
- …Include : + Conduct risk assessments specific to medical affairs and clinical trial /research activities, utilizing a combination of data analytics, ... easy to understand policies specific to medical affairs and clinical trial /research activities that empower the business...talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared… more
- Bristol Myers Squibb (Princeton, NJ)
- …stakeholders to support the synthesis of local trends which would influence successful clinical trial execution. + Member of the Regional Delivery Lead ... to late stage, including lifecycle management. + Deep knowledge of clinical trial operations including monitoring methodologies, systems, regulations/compliance,… more
- Bristol Myers Squibb (Princeton, NJ)
- …and on time and in close collaboration with cross functional stakeholders + Clinical Trial Physician for assigned MASTs, providing medical/ clinical ... MD required (or x-US equivalent) + 5+ years preferred clinical trial experience in pharmaceutical industry setting...talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared… more
