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La missione di AbbVie intende scoprire e fornire medicine innovative per risolvere gravi problemi di salute attuali e gestire le sfide sanitarie di domani. Puntiamo ad avere un rilevante impatto sulla vita delle persone in diverse aree terapeutiche fondamentali: immunologia, oncologia, neuroscienze, oculistica, virologia, salute della donna e gastroenterologia, oltre a fornire prodotti e servizi al portafoglio Allergan Aesthetics. Per maggiori informazioni su AbbVie, visita l’indirizzo Seguici @abbvie su Twitter, Facebook, Instagram, YouTube e LinkedIn.

Principal Research Scientist II

Chicago, Illinois ID dell'offerta 2204368 Categoria Research and Development Divisione AbbVie

This position is in the Toxicology line function within the Preclinical Safety group and will report to the Director, or other senior leader in Toxicology. This role reviews and provides input to genetic toxicology strategies and independently proposes, designs and interprets non-GLP and GLP genetic toxicology studies in support of issue resolution and/or drug submissions to regulatory agencies. This role requires demonstrated effective written and communication skills.

The primary responsibility of this job is to independently serve as scientific expert for studies, during audits and on project teams, committees and other assignments. Accurately identify key scientific findings and effectively communicate findings in reports, presentations, and meetings.  Demonstrate the ability to resolve key project study and assumptions by effectively utilizing available information and technical expertise.  Develop and sustain networks with key business partners.
This role may also serve as GLP Study Director for AbbVie internally conducted studies and external sponsor monitor for studies conducted at contract research organizations (< 20% of time).

Accountable for all aspects of GLP report authorship, including writing and reviewing study reports and preparing assigned components of filing documents that support submissions to global regulatory agencies for drugs in development.

Responsible for all aspects of GLP compliance within assigned studies and related departmental activities. Independently design and assure the conduct and reporting of genetic toxicology studies appropriate to overall development plans and aligned with regulatory expectations.
Propose and apply external scientific and regulatory information to development strategies and business practices.
The genetic toxicology Subject Matter Expert must apply strategic and scientific plans to development programs and functional area needs. The Toxicologist must use his/her scientific judgment to design/critically evaluate and interpret experiments, record, tabulate and report results and significant issues. The Toxicologist must understand and follow established procedures and practices, ensure compliance with established procedures within the function, as well as possess a good understanding of appropriate FDA, ICH and OECD regulations and guidelines.

Basic Qualifications:

  • MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline
  • Strong verbal and written communication skills to effectively communicate scientific data, issues and conclusions; independently work within small teams and in a matrix reporting structure environment; lead scientific issue identification and propose appropriate resolution(s).
  • Responsible for GLP and non-GLP genetic toxicology study design, interpretation and project science within this area of expertise on one or more project teams.
  • Demonstrates Genetic Toxicology expertise with agility, accountability and excellent communication skills.
  • Demonstrates the ability to resolve study design and regulatory issues and key project hurdles and assumptions by effectively utilizing available information and technical expertise, with minimal supervision.
  • Effective writer and communicator of research or other regulatory materials. Proactively seek relevant information in the literature and incorporate this into knowledge of Toxicology practices and overall program issues.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 10 % of the Time
Job Type: Experienced
Schedule: Full-time

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