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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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A thorough understanding of the complex Regulatory, Development and Medical Affairs requirements in oncology, as well as the emerging paradigm for cell & gene therapy. Precigen is advancing an exciting pipeline of novel cell and gene therapy products and to further our efforts we are seeking an Executive Director, Medical Affairs who will be instrumental in creating and building the global medical affairs function at Precigen for our first commercial launch.
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As an Associate Vice President, you would: •Develop, implement, and direct AHC's government affairs activity to support AHC strategic priorities and serve as AHC's lead advocate on policies that help to enrich the healthcare environment, with an emphasis on AHC system projects, within the: Federal government, Maryland state government, Montgomery County government, Prince George's County government, and Washington DC local government.
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Provides strategic advice on complex reporting and technological issues, and problems raised by the RSM team, Regulatory Operations teams, RSA Exchanges, and other FINRA customers, as applicable, in coordination with Regulatory Operations staff, including monitoring and resolving such issues.
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Work cross functionally with USP internal functions including Industry Programs, Global Communications, Science, Strategic Customer Development, Scientific Affairs, Regulatory Affairs to execute digital marketing campaigns based on creative story telling, engaging content and messaging, and audience segmentation.
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As a CMC RA Associate Director Project Leadership, you will provide regulatory CMC knowledge and progressively increasing levels of expertise to TA and non-TA projects within Global Regulatory Affairs(GRA) and AZ technical functions.
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You will drive interactions with key stakeholders across the business including but not limited to Safety Science, Clinical Pharmacology, Business Process Operations, Therapeutic areas, Patient Safety, Quality Assurance and Regulatory Affairs.
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Reporting to the Senior Director, the Hospital Manager of Quality will be responsible for monitoring regulatory compliance, ensuring state, federal, joint commission etc survey readiness, maintaining accreditation, and implementing quality performance improvement initiatives.
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Under the supervision of a senior staff from the Biostatistics group, the incumbent will work closely with colleagues from Data Management, Statistical Programming, Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs.
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Leads and supports advancement of molecules from lead to candidate nomination and IND and regulatory filings, collaborating with preclinical pharmacology and toxicology teams. Proficient in generation of scientific documentation to support submissions to regulatory agencies.
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Provide clinical documentation using malaria databases, NIH electronic medical records, and regulatory documentation of events post-vaccination. Must have experience with WHO and FDA regulatory authorities as it pertains to the conduction of human clinical trials.
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Knowledge and experience working with Tableau, Salesforce Pardot and Salesforce Marketing Cloud. The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients.
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As Program Lead, articulates targets of TPP and CDP to other development functions (e.g. Regulatory, Pharmacovigilance, Statistics, etc.) Takes ownership together with partner functions in Development on the acceleration of program and trial design and innovation for the patient (e.g. digital endpoints, synthetic control arms, RWE/ HEOR, PRO, Medical Affairs.
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Aligns w/ cross functional teams for Medical, Commercial, Government Affairs in support of Opioid Antagonists. 5-10 years Medical Affairs experience in the pharmaceutical or biotechnology industries.
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Develop and oversee global standards, standard operating procedures (SOPs) and corresponding controlled documents that are in line with relevant regulations (e.g., ICH-GCP, and regulatory requirements such as EMA and MHRA) and industry best practices (e.g., CDISC Trial Master File Reference Model.
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regulatory affairs jobs Title: affairs project manager Company: Aerotek in Germantown, MD
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