October 1
• Review advertising and promotional communications for compliance • Lead MLR committee • Liaise with FDA for promotional materials • Develop processes for commercialization • Monitor competitor advertising
• Bachelor’s or M.S./Ph.D. degree in scientific area • Minimum of 15 years with a Bachelor’s, or 13 years with an MS/PhD of relevant Regulatory Affairs experience in a biotech / pharmaceutical setting • Minimum of 10 years supervisory experience • Thorough knowledge of FDA advertising and promotion regulations and guidance • Experience with MLR or promotional review committees supporting product communications • Experience with regulatory submissions of promotional materials • Excellent negotiation skills • Excellent written and oral communication skills • Strong organizational skills
• Discretionary annual target bonus • Stock options • ESPP • 401k match • Health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance • 20 days of PTO • 10 paid holidays • Winter company shutdown
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