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Jobs or company...

Senior Specialist, Clinical Trial Strategy and Submissions

Salary undisclosed
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Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on , , , , and .Job DescriptionPRIMARY FUNCTION/OBJECTIVE
The Senior Specialist of the Clinical Trial Strategy and Submission delivers clinical development regulatory strategies & operations for a designated portfolio of development compounds globally.CORE JOB RESPONSIBILITIES
  • Deliver CTA regulatory strategies & operations for a designated portfolio of development compounds in specified geographic region: WE, EEMEA, LA and specified JAPAC countries in alignment with the overarching global regulatory strategy and region-specific requirements.
  • Ensure the submission strategy for clinical trials planned globally are in accordance with the overarching global regulatory strategy and any risks and issues are highlighted to the Global Regulatory Project Team (GRPT) and study teams within the development operations organization.
  • Ensure study deliverables are achieved in accordance with global regulatory strategies and compliance with evolving global clinical trial legislation (including the EU Clinical Trial Regulation, IVDR, MDR regulations) and company procedures.
  • Primary interface between AbbVie and regulators for EU-CTR assessment procedures
  • Primary interface between global subject matter expert functions and affiliates to deliver clinical development regulatory strategies, operations and outcomes.
  • Populate and maintain regulatory databases (COSMOS & HAQit and any other document management systems as applicable), data collation and tracking of regulatory submissions.
  • Participate in development of internal working procedures. Represent regulatory perspective in cross functional process improvement initiatives
  • Effectively frames complex issues for decision-makers. Prepares and delivers effective management presentations that lead to actionable results.
  • Liaise with Global, Area and Affiliate Regulatory Affairs, Quality Assurance, Regulatory Operations, Clinical Product Development and Supply Chain to identify, resolve and elevate potential issues arising from regulatory approvals and maintenance of CTAs and/or compliance with AbbVie and industry standards. Modify and develop company procedures as necessary. Lead and participate in continuous improvement initiatives within CTS and cross functionally.
  • Support internal and external inspections and cross functional process improvement initiatives. Follows company policies and procedures for regulatory record keeping. Regularly informs regulatory management of important timely issues and the impact on the global program.
  • Supports the Manager/Associate Director with planning and tracking of regulatory activities and agency interactions.
Key Stakeholders
  • Global Regulatory Leads (GRL), Study Start Up (SSU), CMC
Qualifications
  • Required Education: A Degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required.
  • Minimum of 5 years' experience in the pharmaceutical industry with at least 4 years' experience in Regulatory Affairs including extensive global clinical trial experience.
  • Experience of managing multi-national programs of CTAs
  • Excellent understanding of the legislation governing the conduct of global clinical trials (in particular but not only EU Clinical Trial Regulation, IVDR, MDR etc.) and evolving regulatory environment, Good Manufacturing Practices and Good Clinical Practices, ICH and other pertinent guidelines relating to the manufacture and release of clinical trial supplies.
  • Knowledge and experience of medical device legislation as relates to clinical trials is preferable.
Additional InformationAbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.US & Puerto Rico only - to learn more, visitUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: