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The Drug Authorization Specialist, with direct supervision of the Prior Authorization Supervisor, is responsible for managing all work related to drug authorizations for all injectable drug treatment plans ordered by Dana Farber Cancer Institute providers using knowledge of payer coverage policies and applies appropriate payer guidelines to all aspects of drug prior authorization work.
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The Senior Manager, Manufacturing Engineering for Drug Substance Drug Product (DSDP) CMC Manufacturing will be a strategic leader building and overseeing a new organization to oversee Vertex’s first of its kind cell therapy combination product, foreseeing the launch of GMP Manufacturing Phase III (Pivotal) and Commercial stage gates.
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8+ years’ experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency. He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.
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Located in Boston, Jnana brings together scientific leaders in small molecule drug discovery and development, a highly experienced management team, and the backing of leading life science investors Bain Capital Life Sciences, RA Capital Management, Polaris Partners, Versant Ventures, Avalon Ventures, Pfizer Ventures, and AbbVie Ventures.
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10+ years of experience in drug safety/pharmacovigilance within global clinical trial settings, with expertise in FDA, EU, ICH regulations, and Good Pharmacovigilance Practice guidelines. Sr. Director/Executive Director PV and Drug Safety 2020394 Location: Waltham, MA (Onsite) Therapeutic Area: Immuno-Oncology Job Overview: This role will be responsible for managing drug safety data, authoring safety documents, organizing meetings, collaborating with cross-functional teams, ensuring compliance with global drug safety regulations, and providing vendor oversight.
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Productionize AI/ML models on AWS that would become a cornerstone of the company’s drug discovery efforts. Proposal of innovative AI/ML models that address specific use cases in our drug discovery process.
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Deliver: Spearhead drug discovery projects, Design, execute, analyze, and interpret in vitro and in vivo experiments. As a Senior Scientist, you will work within the RNA Medicine team to develop a novel nucleic acid drug development platform.
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A minimum of 2 years of experience in a pharmaceutical industry setting within Drug safety, Pharmacovigilance, or equivalent. Senior Drug Safety Specialist, Compliance - Contract - Cambridge, MA.
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Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA. Ensure compliance with FDA regulations and ICH guidelines to meet all regulatory drug safety and pharmacovigilance reporting requirements.
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Prepare technology portfolio with drug delivery solutions that can address delivery of new modalities, peptide therapeutics, biologics, and small molecules including ability for line extension and life cycle management.
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Certification- Licensure of Alcohol and Drug Counselor (LADC I or LADC II) or Certified Addictions Counselor (CAC) or Certified Alcohol and Drug Abuse Counselor (CADAC) preferred. a leading Massachusetts human services organization, seeks a Clinical Director to join us in our mission to provide high-quality services to adults who face the life-long challenges of mental illness, aging and drug and alcohol dependency.
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Communicate with cross functional teams as DMPK project representative to advance projects through the drug development process. A track record of driving DMPK projects with a focus on drug disposition.
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Provides leadership and vision for the creation of cutting-edge medicinal chemistry and drug discovery strategies for the diversity of diseases and organs of relevance for IMRU. Strong working knowledge and track record of delivery in medicinal chemistry and drug discovery including delivery of candidates to Ph2 or beyond.
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Veeva's Vault Development Cloud helps organizations eliminate silos and transforms business processes across clinical, regulatory, quality, and drug safety with greater efficiency and compliance.
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Oversee the design and protocol writing of clinical pharmacology studies (e.g., food effect, human ADME, drug-drug interactions, QTc, and hepatic/renal impairment) Lead or Co-lead all quantitative pharmacology activities to support both regulatory filings and internal decision-making (e.g., Exposure-Response, QTc prolongation risk assessment, population PK/PD analysis) by working closely with internal colleagues (i.e. DMPK, toxicology, biology, clinical, statistics) and external vendors to advance programs from Phase I to late-stage development.
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drug store jobs Title: assistant store manager Company: Spencer Gifts Llc in Boston, MA
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