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Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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Cross-functional Collaboration & Influence: Work closely and exert influence across Operations, HEOR, Medical Affairs, Regulatory Affairs, and Brand Teams to align global strategies with regional and local needs, maintaining hands-on involvement in strategic initiatives to ensure effective delivery and execution.
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Lead the cross functional study team for the EDODM1 Phase 1 study, including clinical monitors, data management, biostatistics, medical writing, safety, regulatory affairs, and pharmaceutical science and QA team members, both internally and externally.
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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.
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Collaborate with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community. 6+ years' experience in Drug Safety and Pharmacovigilance in pharmaceutical or biotech company, CRO or regulatory agency within Drug Safety/Pharmacovigilance, with both investigational and marketed products.
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Working across Corporate Affairs and with business partners (e.g., HR, Strategy & Finance, Product & Marketing, Meetings & Events, etc.) This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent.
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Murine tumor models and study protocols, ensuring compliance with regulatory, ethical, and quality standards; including serving as Principal Investigator on internal in vivo pharmacology protocols.
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Comprising Communications, Government and Regulatory Affairs, Labor and Workforce, and Community Engagement, the External Affairs Department is responsible for shaping government policy to support offshore wind development and building support for projects by engaging with key stakeholders and delivering local benefits.
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The director will partner broadly with campus constituents such as but not limited to Development/Alumni Relations, LGBTQIA+ Center for Faculty & Staff, Residence Life/Housing, Student Activities, Howard Thurman Center for Common Ground, Student Health Services, Community & Inclusion, Government/Community Affairs, the Newbury Center, International Students and Scholars Office, and Athletics.
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The Senior Research Regulatory Coordinator (RC) works under the direction of the CCI Executive Director, Research Operations Director and Principal Investigator(s) to complete the regulatory requirements of clinical research projects.
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Collaborates closely with cross-functional teams, including process chemistry, analytical development, drug product development, manufacturing, quality assurance, and regulatory affairs, to develop and implement effective process engineering strategies.
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The Director of Medical Affairs at Thermo Fisher Scientific will play a pivotal role in both strategically and functionally leading the North American (NA) Medical Affairs Team, undertaking the initiatives supporting the Clinical Sequencing Division (CSD) activities.
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Learn day to day activities of a Legislative Affairs/Intergovernmental operations AboutMassDOT:The 4,000+ employees of Massachusetts Department of Transportation (MassDOT) takes great pride in connecting the Commonwealth’s residents and communities.
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Maintain required documentation according to DDS, DMH, MassHealth, HUD, DPH, CARF, and all applicable regulatory standards as well as Bridgewell policies and procedures. Provide services to individuals according to DDS, DMH, MassHealth, HUD, DPH, CARF, and all applicable regulatory standards, as well as Bridgewell policies and procedures.
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MedPro is one of the largest recruiters of therapists and nurses from outside the U.S. MedPro currently has contracts with numerous organizations to service a multitude of facilities in the U.S. The company counts among its clients prominent healthcare facilities and organizations such as the Department of Veterans Affairs,HCA, University of Miami Hospital, and Tenet Healthcare.
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regulatory affairs jobs Title: intern Company: Alcorn State University in Boston, MA
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