- Merck & Co. (North Wales, PA)
- …to support summary information provided to the FDA in compliance with all regulatory and corporate record retention requirements.Informs senior management when ... FDA regarding select US topics, primarily including: drug shortages, user fee compliance , import/exports, financial disclosure and freedom of information. This is an… more
- Merck & Co. (Philadelphia, PA)
- …is accountable for meeting customer demand at the External Partner (EP) they support by achieving excellence in Compliance , Supply, Continuous Improvement & Cost ... achieved through a network of internal and external sites that support the enterprise and division strategic priorities.The External Manufacturing Operations Senior… more
- Merck & Co. (North Wales, PA)
- …External Manufacturing & Network Equipment team, in providing technical leadership and support to our company's internal & external packaging network, focusing on ... control and efficiency and providing on-going packaging and device technical support across the lifecycle.The Packaging Technical Operations organization aims to be… more
- Merck & Co. (North Wales, PA)
- …scientific consultation to Our Company's Research Laboratories to support scientifically informed and clinically educated decision making.Responsible for ... and tactical activities. Supports ongoing development and mentorship to support implementation of individualized employee development priorities.Develops and effectively… more
- Merck & Co. (North Wales, PA)
- …clinical trials to world-wide regulatory application submissions and post marketing support .-Design and maintain statistical databases that support multiple ... for the assigned projects. Assure deliverable quality and process compliance .Responsible for effective deliverable development utilizing global and TA standards… more
- Merck & Co. (North Wales, PA)
- …with global regulatory authorities to ensure successful registration and compliance . Global Immunology submission experience in IBD strongly preferred. Primary ... Responsibilities Develop and lead global regulatory strategies to support multiple indications, optimizing labels and achieving timely regulatory approvals.Serve as… more
- Merck & Co. (North Wales, PA)
- …will apply project management, communication, and collaboration skills in support of our clinical trials.-Job ResponsibilitiesResponsible for the operational ... stakeholders (eg, study team, country teams, vendors, committees) in support of clinical study objectives.-Accountable for managing any study specific… more
- Merck & Co. (North Wales, PA)
- …clinical trials to world-wide regulatory application submissions and post marketing support .-The incumbent is responsible for the design and maintenance of ... statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.-The position is a key… more
- Merck & Co. (North Wales, PA)
- …marketed Neuroscience drugs;Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug ... compounds; andSupport of business development assessments of external opportunities.Provide support for other therapeutic areas regarding clinical issues related to… more
- Merck & Co. (North Wales, PA)
- …cardiovascular and respiratory drugsAnalyzing and summarizing clinical findings from studies to support decisions regarding safety and efficacy as well as new drug ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more