- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study… more
- Merck & Co. (Rahway, NJ)
- …end to end Data Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical Data Manager (LCDM); issuing ... the GCTO organization. GDO focuses on data collection, data review and integrity throughout the lifecycle of clinical...Fellowship - Mentoring & networking opportunities within and beyond Clinical Trial Operations Exposure to Senior level… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical ... research areas centered around rare diseases and immune disorders.SummarySenior clinical operational leader accountable for operational planning and execution of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …that support the clinical development and regulatory requirements of a clinical program. Relationships The Senior Medical Writer reports to a Director ... Are you ready to make a difference?The Position The Senior Medical Writer works closely with cross-functional project teams... Development. Essential Functions Authors, edits, and provides QC review of documents to support clinical trials… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indications; Interacts with our Discovery and Research programs for development of early clinical studies. Provides senior level clinical representation at ... senior management of CRO, as needed; Accountable for clinical development plans, protocol profiles and sections of key...Study Lead (CSL)- Clinical Surveillance: Documents ongoing Clinical Monitoring review of data for safety… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; ... Represents clinical function at meetings with health authorities; Oversees management...management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Clinical Science function. He/she will be responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each ... and associated documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of medical review , providing expertise and guidance as lead Medical Reviewer on PMRT. Ensure appropriate early medical guidance and scientific direction is ... Associate Director (AD) is responsible for overseeing all activities related to Medical Review for their assigned Therapeutic Area (TA). The AD is accountable for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an ... in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review - Conducts clinical data review per Integrated Data Review Plan-… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety review meetings and providing medical monitoring of ongoing clinical trials Physical Requirements 10-20% overnight travel required. Development of People ... NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating...make a difference?The Position We are seeking an enthusiastic Senior Medical Doctor with a high degree of scientific… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trials from the clinical science perspective, and ensure the writing of high quality clinical trial protocols, review of clinical data and Clinical ... position may be at the executive director level or senior director level, depending on the scope and size...(writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus… more
- Merck & Co. (Rahway, NJ)
- …with talented and dedicated colleagues while developing and expanding your career.The Senior Trial Initiation Specialist in Global Site Budgets and Payments will be ... responsible for the following:Preparation, execution and delivery of global clinical study site budgets (including all other relevant site budget deliverables)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Senior Director, Head Global PV Quality (DSI/DSE) reports to the Global Head ... collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are...for tactical and strategic GVP audits are in place. Review risk assessment documents stemming from audit outcome to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …queries for information or documents from external sources.Ensure prompt and thorough review of requests for de-identified company clinical trial data.Ensure ... research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for study ... Operating Procedures (SOPs). Manages several complex activities and study types.Our Clinical Research and Pharmacovigilance team push the boundaries of global… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 ... Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …written assessments of relevant medical topics, and supports PV Operations' medical review function. This position supports a senior physician in evaluating ... event level AE causality assessment. This position requires manager review and gains industry knowledge through multiple opportunities. ResponsibilitiesSafety Expert… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study problems.Responsibilities- Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... and clinical study report (CSR): Executes statistical activities for low...medium complexity studies including study design, protocol development, CRF review , SAP development, analysis files development, data surveillance … more
- Aequor (Devers, TX)
- …audits EHS program implementation Job Description: Environmental, Health, and Safety Senior Specialist (EHS Senior Specialist) Onsite role--Local candidates only ... functions across the Devens campus. This may include Commercial and/or Clinical drug substance manufacturing, support of Site Engineering (Maintenance and Metrology… more
- Lundbeck (Bothell, WA)
- …for potency methods for all development programs (from early to late phase clinical development) Author and review SOPs, development reports, and technical ... to determine the potency of drug product for early through late-stage clinical development programs. The successful candidate will have a thorough understanding of… more
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