- Merck & Co. (Rahway, NJ)
- …a Global Labeling Lead, you will guide cross-functional teams in the creation, review , and approval of Core and Local Labeling documents.You will be responsible for ... of labeling experience or relevant pharmaceutical industry experience (eg, Medical Affairs, Regulatory Affairs, Clinical, Pharmacovigilance).Current Employees apply HERE… more
- Merck & Co. (North Wales, PA)
- …may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of clinical data/ ... 5 years of pharmaceutical, clinical drug development, project management, and/or medical field experienceMaster's + 3 years of pharmaceutical, clinical drug… more
- Merck & Co. (Rahway, NJ)
- …data to analyze the safety and efficacy claims of potential medical breakthroughs.Support statistical programming activities for Early Oncology clinical development ... projects. Review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision… more
- Insmed Incorporated (San Diego, CA)
- …and review of clinical study data, support in assessing medical monitoring reports, study integrity/conduct, and study oversightSupport preparation of abstracts, ... report development, and database lock processesParticipate in activities related to data review , database lock, medical monitoring, and query resolutionWork with… more
- Tris Pharma (Monmouth Junction, NJ)
- …pricing, distribution, promotion etc.Deep knowledge of the pharmaceutical Legal, Medical , Regulatory review processDemonstrated experience in driving marketing ... hiring at our Monmouth Junction NJ Headquarters for a Senior Director to lead our small, but productive, Marketing...with other critical functions including Sales, Managed Markets and Medical teams to help drive the growth of the… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Scientist as part of theResearch and Early Development team based in ... Piscataway, NJ. Role OverviewLegend Biotech USA, Inc. is seeking an experienced senior in vivo pharmacologist to join our in vivo pharmacology team responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Review PlanAccountable for the assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, ... for coding of AEs, medical history, and medications when neededAddresses medical questions directly from sites/ Institutional Review Boards (IRBs), and other… more
- Novo Nordisk Inc. (Boulder, CO)
- …the supply of API, during the execution of the job duties, the senior manager should seek to actively support continuous improvement initiatives and identify ... activity Work with internal and external resources to develop and review manufacturing documentation, SOPs, protocols, risk assessments and reports Support equipment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... post trial information on required public forums (eg.clinicaltrials.gov).- Under supervision, review and document CRO-generated reports, such as site monitoring trip… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... as to requirements, regulatory rules and state-specific changes so that final review and approval can be obtained. Submits applications and any additional paperwork… 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 implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and...you ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA)… 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 developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product… 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 developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Senior CQV Specialist as part of the Commissioning and Qualification team based in ... integrityExecutes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentationParticipates in authoring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... to ensure that FDA receives timely and quality submissions, shortening the review process and leading to successful approval of pharmaceutical applications for the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the organization and contact volume grows. Relationships Reports to the Sr . Director, Patient Support Solution Quality/Safety Associate Director. Interacts with ... Support Programs, Patient Safety, Quality, NNI IT and Telephony, Medical Information, Compliance, Regulatory, Legal and Privacy. External relationships include… more
- Novo Nordisk Inc. (West Hollywood, CA)
- …live with the disease of obesity, yet only 2% of them receive dedicated medical treatment. By joining the Obesity Commercial team, you will have the opportunity to ... Impact the local retail market share through coordinating and implementing medical education activities, programs, and special projects Obtain maximum commitment… more
- Genmab (Plainsboro, NJ)
- …Director of US Medical Affairs Solid Tumors Strategy will report to the Senior Director, US Medical Affairs Solid Tumors Strategy Lead. S/he will provide ... conduct of clinical trials in oncology. Proficiency in clinical data review and interpretation.Solid experience in translating medical /clinical information into… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Reports to the Hemophilia Therapy Area Lead. Works closely with Associate Directors and Sr Brand Managers across the Rare Bleeding TA and with individuals in similar ... closely partner with Field Sales, Market Access, Commercial Excellence, Medical Affairs, Strategic Partnerships and Engagement, Customer Experience and Marketing… more
- Genmab (Plainsboro, NJ)
- …regulatory risks and challenges and relevant mitigatory actions, to senior leadership and project teams Prepare/oversee/ review /maintain regulatory documentation ... Information depending on the role for the assigned product Consult with senior management to develop and communicate regulatory strategies and advice for products… more
