- Novo Nordisk Inc. (Plainsboro, NJ)
- …and initiatives to develop solutions to promotional issues, while ensuring regulatory compliance and effectively managing business risks Creatively advise ... About the Department The Clinical, Medical and Regulatory (CMR) department at...mitigation strategies to meet overall business need, while maintaining compliance with US regulatory requirements and company… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to ensure labeling compliance and accomplish company goals. Key Responsibilities Review and provide regulatory guidance on commercial labeling materials to ... About the Department The Clinical, Medical and Regulatory (CMR) department at...Industry trends. This requires labeling verification to include the review across the product family of physician and patient… more
- Genmab (Plainsboro, NJ)
- … regulatory agencies, professional societies, and key opinion leaders Participate in review of and comment on regulatory guidance as relevant As assigned ... and relevant mitigatory actions, to senior leadership and project teams Prepare/oversee/ review /maintain regulatory documentation (eg regulatory sections of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for US, EU and Company Core documents as well as for the review of country labeling deviations.Ensure Compliance with Labeling Regulations and Guidance: ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …process and relevant guidance and compliance requirements with a focus on medical review Demonstrated ability to lead and work within cross functional teams; ... About the Department The Clinical, Medical and Regulatory (CMR) department at... Review team and Medical Information, Medical Affairs, Marketing, Sales, Legal, Regulatory Affairs,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a global context. This role involves overseeing and driving implementation science, ensuring compliance with regulatory and institutional review boards, and ... collaboration - Global Research, Global Development, Strategy Access Marketing, Medical Affairs Regulatory Safety, International Operations, NN International… more
- Insmed Incorporated (San Diego, CA)
- …or Health Hazard Evaluations and Dear Healthcare Professional letters. Performs the medical review of all adverse event reports for seriousness, expectedness, ... updating the benefit-risk documents for assigned products and development compounds. Provides medical expert safety review input into all critical documents for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to ensuring the highest standards of scientific integrity, patient safety, regulatory compliance , and collaboration across therapeutic areas. Ultimately, this ... Affiliates related to Non-Interventional Studies and Health Economics/Outcome Research Provide medical input to regulatory documents for product/project (Core… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Executive Director (ED) for Field Medical Affairs in the US understands our Company's corporate and products/portfolio strategies and work ... cross-functionally with the Global Medical and Scientific Affairs Therapeutic Area teams to align... vision and TA-aligned strategiesA demonstrated understanding of local regulatory agencies and other ethical guidelines, laws, and regulations… 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 ... members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality Leads (RQLs),… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …quality control practices to ensure accuracy and validity of test results and compliance with the requirements of regulatory and certifying agencies. The ... OverviewLovelace Biomedical Research Institute is seeking a Medical Technologist to perform skilled clinical laboratory procedures according to established… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GMP Compliance Programs to assure product quality, integrity and compliance with regulatory guidelines and internal/global standards and procedures. ... of Standards and Procedures (SOPs) and Training Activities: Responsible for development and review of procedural documents that set compliance in QA GMP… more
- Novo Nordisk Inc. (Durham, NC)
- …within the assigned process Provides coaching to Site regarding quality & compliance related activities Facilitates sharing of regulatory & compliance ... Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes &… more
- Novo Nordisk Inc. (Durham, NC)
- …standards within the assigned process Provide coaching to Site regarding quality & compliance related activities Facilitate sharing of regulatory & compliance ... 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases,...us make what matters. The Position Main duties include review of batch reports & release of incoming materials,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …groups within DSI and global entities, advising on legislative and regulatory compliance , lobbying activities, political contributions, public policy ... pharmaceutical compliance . Provides legal support for maintaining an effective compliance program, including legal review and support for policies, training,… more
- Merck & Co. (Rahway, NJ)
- …milestones, and risks within our Company and with external suppliersAuthor and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, ... their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on programs… 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 ... the quality and timely delivery of programming deliverables, including integrated data review plan (IDRP), study data listings and exception reports, sample data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of those functions. Prepares legal documents such as contracts, correspondence (eg, to regulatory agencies), both independently and for review , approval, and use ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...post-law school experience required4 or More Years experience in regulatory , compliance , and legal matters relating to… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to new and prospective customers. Key metrics: Customer Satisfaction, Audit non-conformances, Regulatory Compliance , Cost of Quality, Validation on Time. Job ... and maintaining strong and efficient conformance to all quality expectations and compliance with all regulatory standards. This position is the decision… more
- Tris Pharma (Monmouth Junction, NJ)
- …and pricing, distribution, promotion etc.Deep knowledge of the pharmaceutical Legal, Medical , Regulatory review processDemonstrated experience in driving ... activities and related communications and programs are in full compliance with Medical , Legal, Regulatory and Corporate guidelines; Establishes, oversees… more
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