- Merck & Co. (North Wales, PA)
- …and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional ... practices are consistent with regulatory guidelines, our company's policies, and support business objectives.Serve as the liaison and manages correspondence with… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Responsibilities Acts as legal advisor for at least one key and/or a combination of Global Corporate ... of the role. Global Human Resources (including Benefits) Acts as the legal advisor for Human Resources groups within DSI and global legal entities, managing other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategic legal support and solutions as a brand attorney and the primary legal advisor for the commercial business and operations supporting US approved (or to be ... but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is… more
- Merck & Co. (Rahway, NJ)
- …formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products ... product technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Genmab (Plainsboro, NJ)
- …role will include stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US and Japan Market and Commercial Teams (and others) and ... develops a clear understanding of business needs, acting as a trusted advisor , and ensuring cost-effective delivery of information security services to meet those… more
- Merck & Co. (Durham, NC)
- …level. Collaborates with Operations, Technology and Quality to author regulatory inspection observation responses and completes remediation projects, as required. ... and revise Standard Operating Procedures Support of internal and external regulatory inspections, presenting on topics as needed. Executes and manages Operations… more
- Merck & Co. (Rahway, NJ)
- …external manufacturing sites, manufacturing investigation, process validation, and authoring of regulatory submissions.We are seeking a Senior Scientist to join our ... functional area on cross-functional teams and external collaborations.Author BLA regulatory filings and technical documentationSupport validation of new software and… more
- Merck & Co. (Rahway, NJ)
- …Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our ... Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …time to understand business goals, strategies, emerging risk areas, and the regulatory landscape, ensuring ability to serve as a knowledgeable and effective ... compliance advisor and business partner Analyzes complex business scenarios to...of six (6) years combined pharmaceutical, human resources, legal, regulatory , and compliance experience required OR a minimum of… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Merck & Co. (Durham, NC)
- …Author, review, and/or edit procedures and technical documents to support regulatory filings including standard operating procedures, job aides, and learning ... experience Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements Demonstrated ability to work both independently and as… more
- Merck & Co. (South San Francisco, CA)
- …discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations).Provide clinical pharmacology ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late-stage Clinical Research throughout research sites… more
- Merck & Co. (Rahway, NJ)
- …efforts, responsible for guiding our strategic vision, ensuring compliance with regulatory developments, and positioning the company for sustained growth and ... positioning the company advantageously in the US and OECD regulatory landscapes.Cross-Functional Collaboration: Partner with leaders across finance, treasury, legal,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …is maintained to meet GMP requirements.Support utilities areas in Regulatory / FDA inspections ensuring successful outcomes.Cross functional collaboration with ... standards, Occupational Safety and Health Administration (OSHA) standards, other regulatory agency standards, and good maintenance practices.Support facilities, utilities,… more
- Merck & Co. (Rahway, NJ)
- …validation, collaborating with project teams, biomarker leaders, clinical operations and regulatory affairs on the implementation of these assays in clinical trials. ... To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor .Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto… more
- Merck & Co. (San Diego, CA)
- …that can be deployed in clinical trials. You will also support preparation of regulatory documents in support of clinical trials.- In addition, you will be the site ... in more detail, please contact your HRBP or Talent Acquisition Advisor .#eligibleforERP#DATA2024Current Employees apply HERE Current Contingent Workers apply HERE US… more
- Merck & Co. (Rahway, NJ)
- …submissions and NDAs Regular updates with key cross-functional partners (Discovery/Late-Stage/ Regulatory ), as well as other disciplines Establish novel endpoints for ... To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor .Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto… more
Related Job Searches:
Advisor,
Business Analysis Advisor Regulatory,
Environmental Regulatory Advisor,
Regulatory,
Regulatory Affairs Advisor,
Regulatory Compliance Advisor,
Senior Advisor Regulatory Affairs,
Senior Advisor Regulatory Capital,
Senior Regulatory Advisor,
Sr Advisor Regulatory Compliance