- Novo Nordisk Inc. (Plainsboro, NJ)
- …that support the clinical development and regulatory requirements of a clinical program. The Director will provide high level strategic input into ... NJ. We support programs from early research through late-stage clinical development . We are building for the...of the Medical Writing team. Relationships The Director Medical Writing ( Director ) reports… more
- Tris Pharma (Monmouth Junction, NJ)
- …NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development . Title and salary commensurate with experience. The ... (QA), Pharmacovigilance, Medical Affairs, etc.) on strategic and tactical clinical development issues and initiativesDevelops, authors and executes study… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...ready to make a difference? The Position The Associate Director , Medical Affairs Omnichannel Engagement, role is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Reports to: Vice President, Medical & Science. Work with the VP Medical /Scientific Development , Clinical Operations, Non- Clinical Research, ... including KOLs and Principal Investigators. Essential Functions Support the VP Medical /Scientific Development as the US/international clinical lead… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... development of the team; and between the field-based Medical Liaison team and other NNI units / personnel....throughout the annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs. Has… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an advanced degree required.6-9 years of experience with a bachelor's degree required. Clinical development or post-marketing experience to be able to apprehend ... (SAPs) and statistical outputs (tables, figures, and listings [TFLs]), and other clinical study documentsAuthors or oversees the development of safety sections… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …They will coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and the Medical Liaison ... About the Department The Clinical , Medical and Regulatory (CMR) department...SD works closely with the TA Leadership Team and Medical Director team to identify and execute… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development , maintenance, and ... pipeline.Proactively identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial lifecycle.Standardize… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …- Guide the Clinical Science staff in the creation of the development strategy ensuring the highest scientific/ medical standards in accordance with ethical ... Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical ...will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global… more
- Tris Pharma (Monmouth Junction, NJ)
- …The Executive/Senior Medical Director provides leadership, direction and medical expertise for company’s clinical development programs specifically ... pharmaceutical industry collaborators/partners; Establishes and fosters partnerships with scientific and medical community and presents clinical development … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other ... well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety, will be a product safety lead or part of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …accountability for operational study-level timeline, cost, and quality deliverables.Lead the development of the clinical study plan including critical path ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups ... conduct of clinical trials is required Demonstrates technical expertise within Clinical Development , Medical Affairs, and Regulatory Affairs (CMR),… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …standards. This position ensures quality delivery of medical coding for clinical trials, clinical development , and regulatory submissions. Develops and ... end-to-end delivery of medical coding data for assigned projects/studies collaborating with clinical and medical teams, CROs and other vendors to ensure high… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... of this position is to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry best practices), ensures… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Qualifications- Minimum 9 years experience in the pharmaceutical industry in Clinical Drug Development supporting multiple functional stakeholder groups ... out from associate to leadership levels preferred.- Experience within or supporting Clinical Drug Development processes, roles, data and systems is required… 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 ... About the Department Our East Coast Global Development Hub brings together the best minds in...internal stakeholders Perform or supervise regulatory review of all clinical and nonclinical documents for submissions, eg, clinical… more
