- Merck & Co. (North Wales, PA)
- …Research & Development Division . Our mission is to serve as a trusted regulatory center of excellence and lead successful interactions with FDA regarding select ... Management, Clinical Testing, Clinical Trial Compliance, Communication, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, Finance, Global Communications… more
- Merck & Co. (San Diego, CA)
- …EMA, etc.), including leading meetings, teleconferences, and written communications . Lead cross-functional teams in preparation for regulatory advisory ... Compliance, Leadership, Motivation Management, Pharmaceutical Regulatory Affairs, Regulatory Affairs Management, Regulatory Communications , … more
- Insmed Incorporated (San Diego, CA)
- … point of contact for interactions with FDA and other Global health authoritiesAssist/ Lead communications with FDA and with other Health Authorities (such as ... therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams (CMC,...agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is… more
- Merck & Co. (Rahway, NJ)
- …Additionally, coach and mentor others to grow their technical rigor to lead and/or contribute to regulatory submissions and audits.Innovation and Continuous ... medical device engineering, particularly in the design, manufacturing, and regulatory aspects of Autoinjectors and combination products.Primary Responsibilities:Technical Strategic… more
- Merck & Co. (Rahway, NJ)
- …risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen ... challenges, proactively prioritizing, interrogating and mitigating risks across technical, regulatory and operational factors.- Conducts options analysis and provides… more
- Merck & Co. (Rahway, NJ)
- … Regulatory Compliance, Pharmacovigilance, Pharmacy Regulation, Prioritization, Regulatory Compliance, Regulatory Reporting, Risk Communications ... supplementary monitoring activitiesDevelopment of risk minimization strategiesArchive all relevant documents/ communications as agreed or defined in the applicable proceduresAdditional… more
- Insmed Incorporated (San Diego, CA)
- …and maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections and vendor audits.Ability to ensure that a ... Experience with gene therapy products is preferred.Experience with effectively managing regulatory agency inspection and working with regulators and internal… more
- Merck & Co. (North Wales, PA)
- …TA aligned deliverables that align with V&I Goals and serves as the Lead for the US Medical Affairs Team (MAT) meetings.Establish and maintain strategic partnerships ... Plans.Proactively engages with Country Medical Affairs and TA leadership to lead strategic alignment, optimal resource allocation, and effective representation with… more
- Merck & Co. (Rahway, NJ)
- …and strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible for technical leadership of key ... development and technology teams, supply chain, operations, quality, analytical, regulatory , and project leaders. The successful candidate will demonstrate ownership… more
- Merck & Co. (Rahway, NJ)
- …strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Center of Excellence ... substance and drug product container closure systems including mold qualification and regulatory compliance.- To act as master data stewards and support enterprise… more
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