General Business Support
Participating in strategic decisions impacting the business/local affiliate
Drafting/reviewing commercial agreements
Advising on acceptability of promotional materials and activities and conducting risk assessment
Advising and training on competition law
Litigation support (civil/administrative/criminal)
Regulatory Affairs & Value and Access
Interpretation and advising on the law relating to medicinal products and devices
Advising on tender, pricing, reimbursement and market access related issues
Assisting on legal related interactions with the French pharmaceutical agency (ANSM)
Supporting external GXP inspections and internal audits
R&D/Medical Department Support
Advising on clinical trial related issues (contracts and interpretation of law)
Advising on appropriate interactions with health care professionals and healthcare organisations
Advising the local grants and donations and sponsorships committees
Training on anticorruption/FCPA
Supporting local healthcare compliance investigations
Supporting Data Protection Officer on data privacy issues
Advice and assistance on various corporate administration matters
Administrative and supervisory matters
Manage external counsel and associated budgets
Manage lawyer in French affiliate
Fluent written and spoken French and English.
Excellent written and oral communication skills.
Strong commercial orientation, leadership and organizational abilities.
Skillful negotiator/influencer and ability to constructively challenge and act as sparring partner.
Able to prioritise effectively, delegate and drive clear and timely outcomes
Proactive, “self-starter”, able to issue spot and analyse complex legal problems and present alternative/creative solutions to management.
Good judgment and maturity, able to assess and advise on legal risk and act as a partner to the business in order to enable it to achieve its commercial and strategic objectives.
Strategic thinker, able to utilize knowledge and experience to understand impact of emerging trends and implications for the company.
Self-aware person who can successfully manage client expectations and can work well with a variety of personalities/capabilities in cross-functional teams.
Educational and Professional Requirements: Excellent academic credentials and law degree from recognized university. Qualification to practice law in France and admitted to the French Bar.
Experience Required: Minimum of 10 years’ post-qualification experience gained from a combination of practice at a major law firm advising on life sciences industry issues and working as an in-house counsel for a pharmaceutical/biotechnology company.
Knowledge of ANSM and HAS (Transparency Committee) rules and procedures impacting the life sciences industry.
Reporting: Will report directly to Associate General Counsel in European Headquarters. Will report indirectly to the General Manager of Amgen France.