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Interface broadly with key functions including Discovery Sciences, Preclinical Pharmacology, Pharmaceutical Sciences, Toxicology, Translational Biomarkers, Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late stage Clinical Research throughout sites in the USA, UK and Belgium.
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Phoenixville and the greater Philadelphia area offers excellent schools, affordable homes, colleges, and parks plus a multitude of cultural, recreational, shopping, sporting attractions and social amenities all within driving distance to shore points, Philadelphia, New York City, Baltimore and Washington DC. Pottstown offers extensive arts and culture, shopping, nightlife, and dining experiences.
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Arts and Culture:We are committed to extending our legacy of cultural engagement. Ensures that the work area is clean, tidy, hygienic, and professional at all times; knows and respects Visual Merchandising guidelinesHave a positive attitude, communicates with the team and the manager on a regular basis and has the sense of ethics and integrityTreat others with respect, acknowledges cultural differences, and is willing to learn from those differences.
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In this role, you will be responsible for overseeing National Environmental Policy (NEPA) components such as wetland/stream delineations, threatened and endangered species surveys, and cultural resources assessments.
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Could you be our next Senior Manager of Regional Regulatory Affairs? Be a GRA NA representative for assigned projects to the Global Regulatory Affairs Strategy Team (GRAST) to provide regional input into the delivery of science-based and globally aligned regulatory strategy with GRL.
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O Provides communications between Global Regulatory Affairs CMC and partners within GRA and across and outside of the organization, as evidenced by the successful achievement of CMC regulatory milestones according to project plans, and by the level of partner satisfaction with the support provided by the group.
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Oversee training and development programs, ensuring they align with staff needs, including Indigenous cultural safety, health and safety strategic plans, and early intervention strategies. Spearhead talent management initiatives, including workforce planning, succession planning, and talent development, with a priority on cultural diversity and inclusion.
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Lead and design platform architecture that will enable best-in-class IT capabilities supporting our Company Research Labs Information technology product lines spanning Global Regulatory Affairs, Patient Safety, Quality / Compliance, Pipeline Portfolio Planning and Development Data Consumption.
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The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products.
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The AD partners with other functional leaders in CMC, Regulatory Affairs, Clinical Operation and Quality Assurance in support of the study project teams and ensures timely drug supply for clinical trials.
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Collaborate with Medical Education and Clinical Affairs teams to produce the company’s clinical data through technique guides, whitepapers, case reports, presentations, and journal publications.
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Cross-Functional Collaboration:Partner with medical affairs, marketing and MSL teams to understand product positioning and messaging requirements. Accountable for overall medical training plan and oversight, and delivery of all internal training materials for MSL / Medical affairs use.
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Major metro with a small-town feel, a thriving cultural sector, and an affordable housing market. Strong University presence with over 15-4 year colleges nearby including Villanova, Temple and Drexel University.
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Works closely, collaboratively and seamlessly with peer communications professionals supporting the state including Customer Communications Manager, the Internal Communications Manager, the Director of Communications and External Affairs, the Customer Service Center Communications Manager and the entire Corporate Communications team in corporate to ensure communication integration and maximum effectiveness.
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Comprehensive training in crisis prevention/intervention, trauma informed care, CPR, first aid, and cultural competencies. Devereux Advanced Behavioral Health PA Adult Services located in Berwyn, PA provides a variety of assessment, treatment, and vocational services to adults with a diagnoses of intellectual disabilities, autism spectrum disorders, and concomitant psychiatric and behavioral challenges.
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cultural affairs jobs in Collegeville, PA
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