We are representing a global pre-commercial pharmaceutical company in their search for a Senior Director / Executive Director Regulatory Compliance Counsel.
Why Join Us:
• Opportunity to work alongside the Chief Compliance Officer in continuing to build the commercial compliance program
• Working alongside an established executive team, many of whom coming from large global pharma backgrounds
• Full support will be provided in the development of a robust and technically advanced program
• Remote applicants considered
Expectations first 12 months:
• Develop collaborative relationships with members of the Executive Team and other colleagues
• Assist in continued development of commercial compliance program and implementing roll out as business nears commercial launch
• Work with commercial teams and other stakeholders on a compliance program plan for post-commercial business
Responsibilities:
• Reporting to the Chief Compliance Officer, responsible for providing legal advice and counsel in support of investigational products and brand planning activities in preparation for commercial launch
• Provide legal advice across product portfolio, in areas such as FDA regulations, Anti-kickback Statute, PhRMA Code and other industry guidance documents
• Serve on cross functional teams responsible for reviewing and advising on medical materials, promotional materials and other key external communications
• Advise on clinical development and medical affairs activities such as clinical trial related matters, product labeling, scientific exchange and publications
• This role will serve as the legal function representative on the review team for medical materials, unbranded campaigns and ultimately promotional materials
• Responsible for providing proactive advice and support across brand functions (e.g. Medical Affairs, Marketing, Regulatory, Sales)
• Partner and collaborate with other departments and functions (e.g. Contracting, Privacy, HR, IT)
• Review and approval of various brand activities and tactics
• Serve on cross functional team responsible for product labeling
• Serve on other cross functional teams and governance bodies as assigned
• Prepare and conduct training on a variety of legal and compliance topics
• Assist in the preparation of organization and leadership communications
• Potential management of future team members
Qualifications:
• Essential Education: Juris Doctorate Degree
• Active license to practice law in state where you are located and/or eligibility of in-house counsel registration in California
• Significant level pharmaceutical commercial compliance experience including direct experience advising on Food Drug and Cosmetic Act and associated regulations, Anti-Kickback Statute, FCPA, Managed Markets and Pricing issues
Application Process for Senior Director / Executive Director Regulatory Compliance Counsel:
Qualified professionals are to submit resume to Steve Harrison: steve@conselium.com
