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Bachelors degree in Legal Studies, Business Administration, or Supply Chain/Vendor Management. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.
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Bachelor’s degree in a relevant field, such as business administration, legal studies, or regulatory affairs. Review licensing requirements and develop strategies to meet regulatory obligations.
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Open to diverse work and educational backgrounds including environmental studies, legal, policy, engineering, political science, international affairs, economics, business, finance, liberal arts, etc.
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Assists in one or more areas of the legal team: litigation, commercial matters, employment law, contracts, regulatory matters, subpoena/ records request processing, legal intake and matter management, as assigned by the direct leader.
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This internship is ideal for students currently pursuing a bachelors or masters degree in law, legal studies or related field. Conduct legal research on various topics, including construction law, regulatory compliance, environmental regulations, and zoning laws, to support ongoing projects and legal decision-making.
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Plans, organizes, and directs the activities of Personal Property Activity (PPA), ensuring that Department of Defense (DoD) personal property moves comply with legal and regulatory requirements and meets customer needs.
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Bachelor's degree in legal studies, law, or related field, or an additional eight (8) years of relevant experience in lieu of Bachelor's degree. Demonstrate expert knowledge of multi-state business law, legal and regulatory requirements, and accreditation standards in a post-secondary institution.
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Supports the filing of legal team documents in SharePoint working Cross Functionally with Project Management, Clinical, Regulatory and Medical team members. The successful candidate must have experience managing Phase I-III trials and a strong understanding of clinical operations, GCP, and FDA regulatory environment.
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Collaborate with MSL colleagues to ensure all Investigator sponsored studies are performed according to legal/regulatory guidelines. Plan, manage and ensure execution of studies in coordination with North American and Global Clinical teams as part of a clinical development phase or as part of post-marketing regulatory commitments from study concept through submission.
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Posts and manages disclosure of active clinical studies on clinicaltrials.gov. CUSTOMER SERVICE: Liaison between clinical sites and LifeNet Health internal teams (e.g. Scientific Affairs, Marketing, R&D, Contracts Admin/ Legal) regarding assigned study management.
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RequirementsQualificationsBS/MS in planning, environmental studies, geography, natural resources, physical sciences, or related fieldA minimum of 12 years of experience in the preparation of CEQA/NEPA analysisSeven to 10 years of experience managing environmental documents and analysesA record of successful environmental planning projects and working relationships with clients and regulatory agencies are needed.
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Resources/research - Lead the development and management of impactful materials and resources that demonstrate our commitment to public programs and advance our policy objectives, including large-scale research, actuarial modeling, cost estimates, case studies, bill summaries, legal opinions, testimony and letters to Congress, the Administration and state officials.
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As ESG (Environmental, Social, and Governance) reporting continues to gain prominence globally and closer and more integrated in financial reporting, we recognize the importance of transparent and accurate disclosures to meet upcoming regulatory requirements (e.g., SEC) and stakeholder expectations.
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Assumes accountability for all medico-legal, scientific integrity, human safety and medical governance aspects of PCRU studies. Facilitates and coordinates the conduct of Phase I-IIa-IV studies, including Early Development and Full Development Clinical Pharmacology studies (protocol development, review, Regulatory and IEC submissions.
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This position reports into the US Regulatory and Safety legal team, focusing primarily on US regulatory law matters with responsibility for interpreting and advising on the implementation of key FDrelated laws, regulations and policies, counseling the business regarding regulatory exclusivities, product lifecycle planning, pediatric studies, post-marketing regulatory commitments, generic and biosimilar market entry, and regulatory requirements associated with product labeling.
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