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Associate General Counsel, Healthcare Law

 

Position Summary:

We are seeking an collegial, detail-oriented and motivated attorney to lead the healthcare law function at Achaogen. This person will report to the General Counsel and manage development law, FDA regulatory legal support and be responsible for commercial compliance activities.  

 

Essential Functions:

  • Manage the operation of commercial compliance, working with the Commercial and Medical Affairs groups.
  • Analyze and advise on legal obligations and rights to support achievement of Commercial and Development objectives.
  • Work with third-party collaborators on Commercial issues.
  • Provide advice with respect to rules and regulations governing the development and commercial launch and sale of products, including reviewing and approving publications and  promotional materials.
  • Participate on review committees with respect to medical publications, MSL materials, grants, sponsorships, speakers programs, consultant and advisory board meetings, grand rounds, and similar activities involving communications with healthcare entities.
  • Provide legal protection and risk management advice to management.
  • Lead the designing of policies, SOPs and training to comply with all applicable rules and regulations, including those of the FDA, OIG and CMS, and all applicable anti-kickback, privacy, fraud and abuse, anti-bribery and product liability laws.
  • Assist in compliance monitoring, audits and investigations.  

Preferred Experience:

  • Minimum of 8 years of relevant experience in either a law firm or in-house, preferably in both.
  • Experience working with biotech or pharma organizations with commercial products.
  • Extensive knowledge of compliance functions in healthcare organizations. 

 

Preferred Education:

  • JD or equivalent.

 

Preferred Additional Skills:

  • Motivated and passionate about making a difference for unmet needs in the antibacterial space.
  • Strong communication skills and business partnering ability.
  • Ability to strategically educate and support fellow employees.
  • Ability to manage outside counsel, both nationally and internationally.
  • Strong interpersonal skills and ability to work with others in a positive, collaborative manner, inspiring trust and confidence with colleagues.  
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
  • Current US work authorization required.
  • Ability to travel domestically and internationally. 
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