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drug safety in Boston

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  1. Route Manager-pd relo to Spokane, WA-bzs4519

      Job Summary  Manages collection routes and driver/laborer performance on a daily basis in single or multiple line of businesses.  Essential Duties and Responsibilities  To perform this job successfully, an individual must be able to perform the essential duties satisfactorily. Other minor duties may be assigned and may vary by location.    •Organizes and schedules all necessary resources required to accomplish activities. Coordinates daily operational needs with Maintenance team.  •Plans ...

  2. Drug Safety Associate

    Job Title Drug Safety Associate/Specialist Functional Area Medical Affairs Location USA - Massachusetts - Billerica Job Description The Drug Safety Associate will provide technical and process-related support to drug safety Management (clinical trial and post-marketed) and medical monitoring activities ensuring compliance With relevant regulations and Standard Operating Procedures (SOPs).   Drug Safety Associate Argus experience Either background as a Nurse, Pharmacist or Chiropractor ...

  3. Site Manager

      The Site Manager manages and oversees complex customer presentations, implementations, and cost reduction initiatives. Strong emphasis and focus is given to revenue growth and operational effectiveness. The Site Manager provides leadership to a team of associates in the form of coordinating daily activities, providing direction, and offering support and guidance in the functional areas related to outsourced service solutions such as: shipping, receiving, inventory management, chemical tracking, ...

  4. Area Supervisor

      The Area Supervisor provides leadership to a team of associates (Operators, Technicians, Coordinators, Site Coverage Specialists, Team Leads) in the form of coordinating daily activities, providing work direction, and offering support and guidance in the functional areas related to outsourced service solutions such as: shipping, receiving, inventory management, chemical tracking, warehousing, glass washing, purchasing, desk top delivery, and lab support services. The Supervisor is responsible for ...

  5. ASSOCIATE DIRECTOR DMPK

    Our client is currently seeking a ASSOCIATE DIRECTOR DMPK. The Associate Director, Pharmacokinetics will provide strong PK and PKPD modeling and simulation leadership within DMPK Department. Looking for a Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology with focus on pharmacokinetics. At least Eight years pharmaceutical industry experience in pharmacokinetic and pharmacodynamics modeling support, including using SimCyp and/or Gastroplus PBPK, Phoenix WinNonlin, Phoenix NLME and/or ...

  6. Clinical Trial Manager

      Lead the clinical protocol development process in collaboration with the Clinical Program Leader (team MD): responsible author for clinical protocols, amendments and related documents; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards. Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, ...

  7. Clinical Trial Leader

    Job Title:                        Clinical Trial Leader Department:                Oncology Translational Medicine         Job Purpose     Accountable for all aspects of assigned OTM clinical trials (Phase I/II) including leading Clinical Trial Team(s) (CTT). Number of clinical trials depends on the workload and complexity of the individual trials.   Major Accountabilities    1.        Lead the clinical protocol development process in collaboration with the Clinical Program Leader (team ...

  8. Vice President, Clinical Quality Assurance

    JOB SUMMARY:   The Vice President, Clinical Quality Assurance (CQA) is charged with the development and implementation of the company's Global Clinical and Pharmacovigilance Quality Assurance Plan in alignment with both business objectives and regulatory requirements.  Clinical Quality Assurancedevelops and implements all Good Clinical Practice (GCP) activities for the company and supports the Good Laboratory Practices (GLPs) related to research activities and clinical trial management. CQA ...

  9. Director of Discovery Toxicology - CNS - Newton, MA

    Shall oversee design, planning and execution of early stage studies, species selection, safety markers, and dose selection of biologic drug candidates and provide toxicology support to target pathway selection, candidate prioritization and development transitions as well as: *** Identify potential safety concerns. *** Assess new technologies and databases. *** Evaluate new screening assays. *** Work cloesely with pathologists, pharmacokineticists, pharmacologists, toxicologists and others to ...

  10. Director of CNS Pharmacology & Toxicology - Dedham, MA

    Early stage biotech company focused on life transforming CNS therapeutics seeks Senior Scientist or Director level experience in Pharmacology and Toxicology to work closely with the CEO, VP Research and VP Regulatory taking responsibility for planning, execution of pharmacology and toxicology studies and the preparation of related components of regulatory submissions including IND and NDA packages and response to inquiries from regulatory authorities. Areas of Resposibility: *** Design and plan ...

  11. Director of Toxicology - CNS Therapeutics - Boston, MA

    Shall plan and manage non-clinical safety and toxicology drug development projects for CNS therapeutic entities using internal staff and contract research organizations. Requirements: *** Current understanding of letest toxicology methodology, regulatory requirements and best proctices. *** Track record successfully interacting with regulatory agencies. *** Experience preparing non-clinical regulatory submissions. *** Ability to critically analyze and interpret data and review and edit ...