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Associate Director, Regulatory Legal - United Kingdom  

Company managed [?] Still accepting applications
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Posted on : 07 May 2017

Project Description

  Description:
  • We currently have any opportunity for a qualified lawyer to work within our inhouse EMEA legal team supporting our Medical and Deveopment function and in particular our Regulatory & Development group.
  • This is a specialized role encompassing the management of a broad range of stakeholders both at an EMEA and global level with a significant impact on business decisions and outcomes across the EMEA region. 
  • The job holder will work in alignment with the Executive Director for this area and will be responsible for balancing commercial opportunities with associated legal and compliance risks in a complex and fast evolving regulatory environment.

 
 Key Responsibilities:  
  • Provide legal advice and support to the Medical & Marketing/Brand functions for defined therapeutic areas working as a business partner 
  • Assist with the Approval of Brand Plans and strategic planning tools for major brands and therapeutic areas 
  • Provide support and advice throughout the lifecycle of products from early development to launch 
  • Manage the resolution of marketing and promotional disputes and assist with publication planning 
  • Draft, review and negotiate a variety of third party and Clinical Trial Agreements alongside Scientific  Exchange and Clinical trial data release 
  • Partner with medical teams on approval of Core medical plans and strategic planning tools for major brands 
  • Advise on Investigator Sponsored Research (ISR) activities and represent the EMEA Legal function on ISR oversight team   
  • Provide expertise on legal compliance issues relevant to Marketing & Medical functions e.g grants and donations patient support programmes etc 
  • Attend congresses to monitor competitor activity and support company  team in any alleged non-compliant activity 
  • Support internal and external investigations and respond to external agency inspections/audits 
  • Supports regional and global projects that involve complex or difficult issues requiring a high degree of legal skill and business acumen including often difficult judgments on contested areas and issues 
 

Experience required  
  • Qualified lawyer , able to evidence good knowledge and experience in the legal environment related to the marketing and distribution of pharmaceuticals and product  life cycle management, either as a corporate lawyer or from within a law firm 
  • Knowledge and understanding of key business, legal and compliance issues within pharma and life science industry 
  • Experience in drafting and negotiating of clinical trial, non-interventional study and ISR agreements 
  • Hands-on experience of working in multi-functional, cross-cultural teams 
  • Experience of leading legal support in global project teams 
  • Able to influence at all levels within the organisation and build trust and credibility with the EMEA Leadership team