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Associate Director, Regulatory Legal Endon United Kingdom,  


Posted on : 13 May 2017

Project 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 Astellas 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 Location: Hillswood

Locations

Hillswood, United Kingdom

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