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Review and approve Vendor and Kura GMP Quality Events. Provide QA review of CMC related sections of regulatory filings. Review and approve executed batch records for associated Regulatory Standard Materials, Intermediates, Drug Substance and Drug Product and determine final batch disposition.
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With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
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Will be responsible for the Synthes and Mitek Quality Management Review. The Senior Director Quality Engineering will be accountable for the development, execution, and delivery of quality strategies for DPS TECA and Mitek Sports Medicine lifecycle management (LCM) and new product introduction (NPI) engineering activities.
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Perform clinical review of data listings and essential study data within generated statistical reports (e.g., SAS outputs) and other available data surveillance tools (e.g., Spotfire, Rave) and partner with Data Management in generating relevant queries.
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Perform final point-to-point review and red line corrections and return to application engineer to make corrections. Work with panel shop on panel design and motor starters and review completed panels to ensure they meet quality standards.
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Join Takeda as a Scientific Director, Pathology in Cambridge, MA, where you will be responsible for active cross-functional collaboration, interdisciplinary project team participation, scientific leadership in the design and implementation of safety assessment strategies to support program advancement and decision-making, primary evaluation and peer review of pathology specimens and data, preparation and review of regulatory documentation, study reports and manuscripts.
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Draft revisions of existing personnel policies for review by the SMT and ultimately approval by the HLA Board of Directors. Make the formal job offer, negotiating terms of employment in coordination with the hiring manager and SMT members, and draft job offer letters.
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In collaboration with Clinical Sciences, Biostatistics, Clinical Operations, and other key Development functions, responsible for the design of clinical trial databases, which includes, but not limited to, CRF Development, Database Validation, and Data Review tools in accordance with ICH/GCP guidelines and current regulatory requirements.
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3+ years compliance background with a broker-dealer, mutual fund, or ETF business with 1+ years advertising review experience. Review, provide advice, and approve ETF communications including new fund launch materials, market commentaries, product marketing, web, tools, social media, thought leadership and sales presentations.
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Review daily and weekly docket reports provided by the central IP Docketing Department. Review and confirm that all annuity related correspondence is processed according to the firm's risk management procedures.
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Work closely and collaboratively with attorneys, paralegals, finance, operations, security, risk, privacy experts, business development, and account teams on a variety of matters, which might include IP matters, agency law, media buying, creative services, data ownership, data privacy compliance, document review, dispute resolution, and internal reporting.
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Collaborate with the clinical development team on the review, analysis, and interpretation of study results and assure appropriate data review and accurate data reporting. Support and develop data outputs for various presentations including peer-review publications.
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Draft, review and revise agreements with alternative investments sponsors for the onboarding of products onto LPL’s alternative investments platform. Juris Doctor degree (barred in your state of practice) with 5 to 8 years of experience working with alternatives investments at a law firm, asset manager or broker-dealer.
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The Regional HSE Manager is responsible for promoting and enforcing the corporate Health, Safety & Environment (“HSE”) program, providing safety support to construction operations, and mentoring regional site safety professionals.
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). Where permitted by federal or state law, Fidelity will also conduct a pre-employment drug screen, which will review for the following substances: Amphetamines, THC (marijuana), cocaine, opiates, phencyclidine.
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review puerto rico jobs Title: regional manager in Boston, MA
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