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We’re a leader in staffing Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, HEOR, Market Access, and Sales & Marketing roles. Medical Science Liaison, Hematology/Oncology (Northern CA) TMAC (TMAC Direct) - San Francisco, CA, United States Tagged: MSL, Medical Affairs, Medical Science Liaison, Oncology, Hematology , Field Medical , Pharmaceutical, TMAC Direct Hire Hematology/Oncology MSL Expansion – Top BioPharma CompanyTMAC’s direct-hire service, formerly known as TMAC Direct, is an executive search firm and Pharma’s Complete Recruiting Resource.
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Capability in managing deliverables essential for regulatory permit applications, CEQA documents, and environmental due diligence investigations (e.g., wetland delineations, rare plant surveys, habitat assessments, biological resources technical reports.
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Collaborate with IT business partners to identify and mitigate information security risks in key functional areas such as External Affairs (ESG), HR, Operations, Engineering & Construction, Development.
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Drive awareness among Pfizer senior leaders of the value created / ROI from oncology development-focused AI/digital technological innovation, and work with Oncology Scientific Affairs and Strategic Partnerships colleagues on external communications on these topics.
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The Vice President of Public Affairs is a member of Essential Access Health’s Senior Management Team responsible for providing leadership and mentorship to the Public Affairs department, and oversight of organizational activities related to public policy, advocacy, strategic communications, and community engagement and outreach.
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Advanced knowledge of the international/sustainable development, public policy, and public affairs and international development job markets spanning the public, non-profit and private sector (in the US and internationally.
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Our Regulatory Affairs team is seeking a highly motivated Regulatory Operations Manager. Reporting to the Senior Director of Regulatory Operations, you will be responsible for assembling, formatting, and publishing regulatory dossiers (e.g., IND, CTA, BLA, MAA) for global registration and lifecycle management submissions (e.g., supplements, amendments, variations) to meet corporate objectives for both ongoing business and new product development.
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Competency in managing the work products needed to support regulatory permit applications, CEQA documents, and environmental due diligence investigations (e.g., wetland delineations, rare plant surveys, habitat assessments, biological resources technical reports.
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Cross-functional Collaboration: Collaborate with cross-functional teams, including clinical development, regulatory affairs, market access, and commercial teams, to align medical affairs activities with clinical trial objectives, regulatory submissions, market access strategies, and commercialization plans.
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Experience with clinical trials regulatory affairs, or related clinical trials experience such clinical research coordinator experience. Ensure that all investigators maintain the proper credentials and maintain these records in central regulatory binder (e.g. medical licenses, CVs, GCP/HSP certifications, NCI CTEP registration, SIP accounts, etc.
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Ability to create procedures to interpret and align with regulatory policies, while enabling investigators perform appropriate level of due diligence. To be successful in this role, you must have a demonstrated ability leading a global trade compliance function, with a special focus on economic sanctions and foreign trade laws.
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In this role you will join a team of program managers, uphold and maintain the Cash App product’s licensing and regulatory obligations, and manage projects and strategic initiatives concerning parties external to Cash App, such as regulators, partners, and consultants.
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Ability to communicate and collaborate with other functional areas including drug discovery, nonclinical toxicology, CMC, clinical development, quality assurance and regulatory affairs. Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology for small molecules and biotherapeutics; experience having direct interaction with FDA and other regulatory agencies, including submission of IND, NDA and other regulatory documents is required.
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At Mercury regulatory compliance is not just a necessity but a competitive advantage that can set us apart as the leader in the space. Your team will manage all of our existing and future regulatory relationships, helping to establish Mercury's reputation as an effective steward of the financial system.
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Serve as the main administrative coordinator for the Office of Student Affairs events and work independently to oversee event logistics (including event planning, social media, event promotion, room set-up/clean-up, catering, AV, and IT) and coordinate with departments and offices on main campus and at the law school as needed.
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regulatory affairs jobs Title: sr regulatory affairs Company: Beigene in Oakland, CA
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