- 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
- 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
- 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 ... external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key...Responsible for all areas related to patient safety in clinical trials Act as member of the trial… 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 ... across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as a member… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …that market access considerations and needs are incorporated into future clinical trials, pre-launch, and commercialization initiatives for inline and pipeline ... shape Global Market Access / Global HEOR strategies and trial design Ensures alignment on access strategy and key...committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and… 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)
- …medicinal product dossiers (IMPD), investigational new drug applications (IND), clinical trial applications (CTA), marketing authorization applications (MAA), ... submissions. Relationships The Principal Medical Writer reports to a Director of Medical Writing. The Principal Medical Writer is...committees Informed consent and assent forms Lay summaries of clinical trial results Clinical evaluation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …may include Medical Affairs, Regulatory Affairs, Marketing, Learning & Development, Clinical Trial Management, and Clinical Development. Essential ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...Nordisk, Inc. RelationshipsThe fellow will report to the Fellowship Director throughout the two-year program and will also have… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provides US market access input to Global and US stakeholders to inform clinical trial programs, guide evidence generation development, payer value stories, and ... ensure fact-based decisions are generated. Relationships Reports to the Senior Director , Rare Value Communications & Pricing. Interacts internally with team… more
- Daiichi Sankyo, Inc. (Bernards, 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
- AbbVie (Branchburg, NJ)
- …Development Plan and is responsible for: + Ensuring alignment between the IEST, and Clinical Trial Team(s) + Developing the proposed clinical milestones with ... Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Clinical Development will have global or...the project-related clinical development budget with the Clinical Trial Team and Project Manager +… more
- Bristol Myers Squibb (Princeton, NJ)
- …teams to support clinical development and ensure the integrity and quality of clinical data and clinical trial subject safety. This leader will sit ... the planning, conduct, and reporting of internal and external audits of clinical trial investigator sites, vendors, and proceses/systems, including for-cause and… more
- Bristol Myers Squibb (Princeton, NJ)
- …of smart systems and optimal approaches to support the end to end clinical trial data lifecycle, from collection through submission. + Holding accountability ... their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , Clinical Data Standards is a leadership...**Experience Requirements** + At least 12 years of global clinical trial expertise and a successful track… more
- Bristol Myers Squibb (Princeton, NJ)
- …motivate and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs) **Position Responsibilities** + Accountable for the ... Scientists (CS) within the asset and/or indication + Responsible for managing clinical trial physician(s); attracting, developing and retaining top talent;… more
- Bristol Myers Squibb (Princeton, NJ)
- …team of outsourcing managers within a specific therapeutic area(s) and manages clinical trial vendor partnerships that supports alliance and outsourcing ... management across multiple service categories of clinical trial activities in R&D. **Key Responsibilities**...talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared… more
- Colgate-Palmolive (Piscataway, NJ)
- …role leading clinical programs **Preferred Qualifications:** + Proficient in clinical trial management software and statistical analysis tools + Knowledge ... smile and join our global team! We are seeking Director , Clinical Research with a strong background...clinical research + Coordinate the safety monitoring of trial participants and ensure reporting of adverse events +… more
- Bristol Myers Squibb (Princeton, NJ)
- …programs. + Leads the Clinical Science team in the planning and execution of clinical trial activities to support the Clinical Development Plan for the ... studies within assigned area + May serve as a Clinical Trial Lead or Co-Lead as needed...talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared… more
- Bristol Myers Squibb (Princeton, NJ)
- …clear product vision and strategy for the clinical data ecosystem especially with clinical trial design and data science methodologies to enable clinical ... We are seeking a highly motivated and detail-oriented Associate Director - Product Manager with broad clinical ...talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared… more
- Sanofi Group (Bridgewater, NJ)
- ** Clinical Research Director ** **About the Job**...Reporting to the Global Project Head, the CRD leads clinical trial strategy and execution of assigned ... program(s) within the clinical development team, including interactions with Clinical ...Reviews the Informed Consent Form, Written Subject Information and Trial Disclosure Form. + Reviews the study specific committee… 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
