29 days old
2018-03-212018-04-20

Senior Scientist, Clinical Evaluation

Abbott
Santa Clara, CA

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Position Summary

Oversee the development of Clinical Evaluations (Plans and Reports) for new and existing medical devices, utilizing skill set of scientific project management, content expertise, knowledge of research design/methodology, and medical writing/editing. Provides scientific expertise throughout the development and implementation of clinical evaluations and other risk management deliverables. Work significantly with cross-functional teams and independent medical experts to develop deliverables for the Clinical Affairs team.  Interacts with regulatory agencies as needed and will use their scientific and medical knowledge to provide directives to staff independently as well as directed by your manager.

Main Responsibilities

  • Takes lead as scientific project manager, writing/editing scientific content of deliverables and managing their timelines and the contribution of cross functional input.
  • Writes Clinical Evaluation Plans and Clinical Evaluation Reports and other clinical deliverables.
  • Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Risk Management, Clinical Project Management, external CROs or Medical Writers, Training, Senior Management and investigational sites as directed by your manager. Conducts team meetings, drafting and sending routine correspondence (e.g., newsletters) and/or by presenting regular updates to senior staff.
  • Creates, manages, or participates in timelines of deliverables, and budgets by utilizing the appropriate project management tools, selecting providers or external medical writers, managing vendor contracts as requested, and ensuring expenditures are within budgetary guidelines
  • Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
  • Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practice.
  • Participates in and supports audits.
  • Participate in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics.
  •  Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

    Accountability

    Understands business environment and relates extensive knowledge of internal and external technological activities to trends. Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. Participates in the development of other technical contributors by facilitating training and providing feedback and guidance. May lead a project team. oversees and directs external CROs and medical writers. Acts as a mentor to less-experienced staff and may provide work direction or supervise other technical employees. Exercises judgment independently. Plans and organizes project assignments of substantial variety and complexity. Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives. Will perform this job in a quality system environment.

    Qualifications

    Bachelor's degree required, advanced degree preferred. Degree in the sciences, medicine, or similar discipline highly preferred. Minimum of 5+ years of related work experience with a complete understanding of specified functional area, or an equivalent combination of education and work experience

    Preferred Skills and Experience: 

    • Medical Device Experience
    • Strong Project Management Experience
    • Strong Medical Writing/Editing Experience
    • Scientific/research background (i.e., has understanding of research design, methodology, and statistics)
    • May consider less experience and hire at lower level


      Job Family: Clinical Affairs / Statistics
      Division: AVD Vascular
      Travel: Not specified
      Medical Surveillance: No
      Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Senior Scientist, Clinical Evaluation

Abbott
Santa Clara, CA

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Senior Scientist, Clinical Evaluation

Abbott
Santa Clara, CA
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