- Daiichi Sankyo, Inc. (Bernards, NJ)
- …an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing ... plans from FIH to post registration. Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Merck & Co. (Rahway, NJ)
- …of clinical data/medical protocol deviations in collaboration with the Clinical Director .Builds talent and capabilities of direcUindirect team members ... SummaryThis position drives scientific planning, strategy and execution of Phase 1-4 clinical studies. Under the direction of the Program Lead, you will collaborate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... with board eligibility preferred Experience Qualifications1 or More Years of clinical experience preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative… more
- Merck & Co. (Rahway, NJ)
- …job that provides a high degree of technical and project management responsibility. The Associate Director - Process/Facility Lead position will report to the ... infrastructure.- Responsibilities include the following:The process/facility lead role at the Associate Director level will serve as a technical mentor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for ... producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of ... Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict... research (ESR) initiatives, ensuring strict adherence to Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs), Food… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Strategic Planning provides strategic insights ... are tracked and ensure implications are assessed and communicated on timely manner- Clinical Development Life Cycle Management Decision Support: Be the key point of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are currently recruiting for an Associate Director Global Oncology Marketing Hematology for a non-covalent inhibitor in Leukemia and Lymphoma.- ... opportunity to help patients and expand our company's oncology hematology portfolio.The Associate Director of Global Oncology Marketing will report to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory ... Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience:- 7 or More Years Outsourcing, health sciences or related field ( clinical trials) required- 7 or More Years Deep experience in pharma procurement ... & category management required- CRO experience preferred- Strong knowledge of clinical trials preferred- Demonstrated ability to leverage digital data and analytics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft labeling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned studies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity ... studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned studies… more
- Merck & Co. (North Wales, PA)
- …We are currently recruiting for someone to join our US marketing team as the Associate Director , Product Marketing Owner - HCC / Ecosystem for the HIV Franchise. ... ownership of brand and HCC strategy and execution. This position will report to the Director , US Commercial Leader (USCL) and will be based in the Upper Gwynedd, PA… more
- Merck & Co. (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of… more
- Merck & Co. (North Wales, PA)
- … trials and will interact externally with key opinion leaders.Specifically, the Associate Vice President may be responsible for:Evaluating pre- clinical and ... Job DescriptionThe Associate Vice President (AVP) has primary responsibility for...Executive Director , Senior Director , or Director level personnel responsible for oncology clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …robust publication plans for the Therapeutic Area and respective products. Mentor Associate Director Publication leads on publication planning and execution ... research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team… more
