Director, Preclinical Subject Matter Expert, Regulatory Affairs and Drug Development Solutions

Director, Preclinical Subject Matter Expert, Regulatory Affairs and Drug Development Solutions

IQVIA

Multiple Locations

PURPOSE

Provide preclinical and toxicology project support within the newly formed Preclinical Center of Excellence (CoE) within the Regulatory Affairs and Drug Delivery Solutions (RADDS) department.

Prepares and/or reviews relevant preclinical regulatory submissions to support clinical trial and marketing authorization activities for either internal and/or external clients. Independently provides regulatory support for more complex projects.

RESPONSIBILITIES

  • Acts as a preclinical subject matter expert on complex projects, which in some cases may include technical writing and/or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate;
  • Competently writes regulatory and/or technical documents with minimal review by senior staff;
  • Strong, proven leadership skills and the ability to work effectively with senior management and delivers positive messages to staff;
  • Establishes relationships with many customers; may meet face to face without rest of team to discuss technical/regulatory issues and present lessons learned;
  • Adopts a proactive and flexible approach to resolve any issues;
  • Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognized and challenges when appropriate, may seek guidance from senior staff as appropriate;
  • Give guidance and mentorship to junior colleagues across the organization (not limited to direct reports), including feedback on the quality of client deliverables, supporting technical learning, and will assist in their broader training and development;
  • Present to clients at bid defense meetings by phone or in person, for a range of regulatory deliverables, at discretion of senior management;
  • May write new regulatory SOPs, and/or propose revisions and/or act as reviewer for regulatory SOPs, as assigned and appropriate;
  • Will be involved in regulatory and/technical thought leadership activities within and external to IQVIA in areas related to preclinical development and toxicology;
  • Performs other tasks or assignments, as delegated by RADDS senior management.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Demonstrates comprehensive regulatory and technical expertise related to preclinical development;
  • Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach;
  • Strong software and computer skills, including MS Office applications;
  • Demonstrated skills in chairing small meetings;
  • Ability to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervision;
  • Ability to propose revisions to SOPs or suggest process improvements for consideration;
  • Prior people management experience is a plus.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Degree in life science-related discipline or professional equivalent plus at least 10+ years relevant experience* in preclinical product development, supporting preclinical regulatory aspects, or in designing and overseeing preclinical and toxicology studies to support drug development (*or combination of education, training and experience);
  • Preference will be given to those with current or previous client-facing or consulting experience;
  • Board certification in toxicology preferred [Diplomat in American Board of Toxicology (DABT) or European Registered Toxicologist (ERT)].

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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