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Prepare and file responses to USPTO office actions and manage patent application prosecution. Firm Type: Law Firm, Experience: 1 Years, A law firm in Boston is seeking an Intellectual Property Patent Agent with a strong technical background in chemistry.
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Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF) Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF.
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Oversee the development of study-specific CDM documentation such as eCRF specifications, eCRF completion guidelines, edit check specifications, and data management plans identifying and mitigating risks to data quality and proper inclusion into the Trial Master File (eTMF.
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Prepare inactive files for offsite storage or digitization, performing file culling activities as requested. 1 year file, records, imaging/scanning experience. Assist client with retention and file transfer activities, obtaining relevant files, preparing file indexes, staging for review, and preparing for shipment.
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Oversee the scoping and review of information gathered from firm files for use in discovery, responses to subpoenas and file transfer obligations in collaboration with the firm's Office of the General Counsel, Information Governance department and the Litigation/eDiscovery department.
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Design analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standards if applicable. Provide statistical input for Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans, and serve as an independent statistician providing data and analysis support for DMC review.
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File review and legal analysis of workers’ compensation claims. Legal research and drafting of client correspondence, discovery devices, summations, appeals and appellate briefs. Leading prominent firm is seeking an Associate Attorney with 3-5 years of Workers' Compensation Defense experience for their growing Richmond, VA office.
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As applicable, act as Subject Matter Expect for oversight of the electronic trial master file (eTMF) (provided by third party vendor) across trials and vendors. We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD.
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Experience supporting interactions with FDA, EMA, Notified Bodies and other global health authorities specifically related to Combination Products and Device submissions (e.g., IND, CTA, IMPD, BLA, MAA, NDA, 510(k), Notified Body Opinions, Technical File submissions, global post approval submissions, etc.
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Establish collaboration with Takeda teams and leadership through networks and enable CMC regulatory team’s success in meeting goals/objectives on drug-device combination and allied filings. Works effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (e.g., Growth & Emerging Markets, Strategy, Labelling, etc.
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This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. Acts as Foundational Subject Matter Expert/Platform Lead within Takeda on the topic of global regulation pertaining to Design Controls for devices and combination products.
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Attend file audits, litigation attorney meetings, and trial clinics. Prepare and file appropriate post-trial motions. Meet with clients and file lawsuits. Today, Rubenstein Law is recognized as a premier name in Personal Injury, representing clients in a variety of case claims, including auto injuries, slip and fall injuries, catastrophic injuries, premise liability, medical malpractice, child & birth injury, motorcycle accident cases, and traumatic brain injury (TBI) cases.
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Create master DMPK data file and initiate multiangle PK related data analysis. Support DMPK activity in research and development projects in Drug Metabolism and Pharmacokinetics (DMPK) team. generated internally or externally in DMPK, toxicology and/or formulation.
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Assisting with managing worldwide IP portfolio, including identifying patentable inventions with internal partners and engaging with outside counsel to draft, file, and prosecute patent applications.
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Founded ~10 years ago, our client is cash flow positive and is a pioneer in the file sharing and collaboration platform industry. Our client has notable wins with Victoria's Secret, NFL, Kraft Group, GE Aerospace, Cigna, and Humana, just to name a few.
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file job in Somerville, MA
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