- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management ... activities pertaining to clinical trials, including but not limited to: data management...tool and system development, validation and maintenance, data integrity review and reconciliation, query management, and database lock preparation/execution,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …& retention activities Obtain expert medical community input Regulatory liaison: Write and/or review clinical sections of clinical trial reports, statistical ... certification or relevant therapeutic area experience in diabetes, CV or Obesity required Prior clinical research or related experience (eg monitoring of … more
- Merck & Co. (North Wales, PA)
- …products as it relates to deletions, divestitures, and supply issues.Accountabilities:Medical Review of US and Global Promotional MaterialsProvide clinical ... promotional strategy and messaging based on scientific evidence and clinical context.Member of Promotional Review Team (PRT)...of twelve (12) months of service in current position prior to applying for open positions.If you have been… more
- Merck & Co. (North Wales, PA)
- …to the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and ... objectives.Serve as the liaison and manages correspondence with FDA's promotional review divisions Office of Promotion and Advertising Review (OPDP)/Advertising… more
- Novo Nordisk Inc. (Tacoma, WA)
- …guidelines, chronic care models, protocols, etc. to engage HCPs in clinical conversations to appreciate how they manage patients with diabetes and where they ... the opportunity to help people with obesity receive the care they deserve. The Novo Nordisk aspiration is to...maintain advocacy of customers aligned to company, brand and clinical goals. The OCS develops local strategies and executes… more
- Novo Nordisk Inc. (Chicago, IL)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health- care -provider interactions and developing and implementing regulatory strategies with...the SD serves as a key member of the Clinical Trial Strategy Team, provides additional analytic support to… more
- Merck & Co. (North Wales, PA)
- …and world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes creation and validation of ... study data deliverables using Extensible Markup Language (XML), Study Data Reviewer Guide (SDRG), Annotated Case Report Form (aCRF)), collaborating and consulting… more
- Novo Nordisk Inc. (Montclair, CA)
- …who need them most. At Novo Nordisk, we are the world leader in diabetes care and a major player in defeating other serious chronic conditions such as obesity, ... in order to influence formulary status, as applicable May analyze impact of managed care in the territory and its effect on prescribing decisions, and modify sales… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... of this job is to oversee statistical vendor deliverables, perform programmatic review of analysis datasets and Table, Listing, and Figures (TLFs) generated by… more
- Merck & Co. (Boston, MA)
- …representing TMed at governance for the Immunology portfolio (discovery therapeutic area review , early and late-stage clinical governance), and fully supportive ... Immunology strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.-The AVP provides strategic oversight for the early … more
- Merck & Co. (Rahway, NJ)
- …scientifically sound and meet worldwide regulatory and marketing needs.Perform comprehensive review of protocols, statistical analysis plans, clinical study ... developing and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical , Regulatory, Statistical Programming, Data Management, and our Company's… more
- Merck & Co. (Rahway, NJ)
- …include but are not limited to: 1. Develops detailed project plans for the collection, review , and cleaning of all clinical data for assigned trials within a ... Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a...of twelve (12) months of service in current position prior to applying for open positions.If you have been… more
- Merck & Co. (North Wales, PA)
- …and Label Evaluation and Development Team.Conducts initial Investigational New Drug application/ Clinical Services Agreement content review and approval to ... and/or subsidiaries for all applications and submissions. Responsible for regulatory review and final approval for all submissions and associated documentation.… more
- Merck & Co. (Rahway, NJ)
- …for related drug/vaccine projects in Late Development Statistics.Interacts with Clinical , Regulatory, Statistical Programming, Data Management, and other company ... Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine… more
- Merck & Co. (North Wales, PA)
- …knowledge and editorial skills to contribute to medical education and clinical decision support for healthcare professionals, while also providing high quality ... viewed by more than 1 billion users each year.A minimum of 5 years clinical experience and demonstrated writing skills are mandatory. Current clinical activity… 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 ... organization. From health- care -provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …pharmacology, vaccines, and biologics in conjunction with functional area and clinical development leadership. Contribute to the business development strategy within ... biomarker discovery, clinical trial needs and Companion Diagnostic/Diagnostic programs in conjunction...of internal subject matter expert input and senior management review and approval. Work closely with search and evaluation… more
- Merck & Co. (Rahway, NJ)
- …play a crucial role in supporting the process automation systems within clinical manufacturing.-The Automation Specialist - Engineering Auto Eng position will report ... and non-capital improvement projects, and the automation systems spanning various clinical manufacturing facilities.- In this role, you will be responsible for… more
- Merck & Co. (North Wales, PA)
- …for stakeholders as needed.Build and maintain excellent relationships with clinical investigators, scientific leaders, external authors, journal editors, and ... management experience at or supporting -pharmaceutical/biotech companies related to the clinical development processAt least 2 years of experience in publication… more
- Eisai, Inc (Exton, PA)
- …provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through ... early to late stage manufacturing programs.This position will be responsible for the review and interpretation of analytical testing data as well as protocols and… more
