About the Role:
Responsible for leading the regulatory review of medical education and commercial advertising and promotional materials for product, disease state, and training/education programs. Leads the Promotional Review Committee (PRC) process for assigned products and independently reviews materials as a subject matter expert to ensure compliance with FDA regulations, guidance, and internal policies. Works closely with cross-functional teams to support compliant and effective promotional strategies, assess regulatory risk, and ensure timely submissions to FDA.

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Your Contributions (include, but are not limited to):

Requirements:

• BS/BA degree in Life/Health Sciences or related field AND 8+ year's of Regulatory Affairs experience at a biotech, pharmaceutical or device company, including significant experience in Advertising & Promotion process management. OR

• Master’s degree in Life/Health Science or related field AND 6+ years of similar experience noted above

• Anticipates business and industry issues; recommends relevant process / technical / service improvements 

• Demonstrates broad expertise or unique regulatory knowledge about advertising and promotion 

• Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team 

• Ability to work as part of and lead multiple teams 

• Good leadership, mentoring skills and abilities; typically leads lower levels and/or teams

• Excellent computer skills 

• Excellent communication, problem-solving, analytical thinking skills

• Sees broader picture and longer-term impact on the organization

• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

• Excellent project management and strong project leadership skills

• Exhibits strong organizational skills and high attention to detail. 

• Possesses excellent interpersonal skills and can work effectively with a variety of personnel from different functional disciplines

• Ability to work independently with minimal direction, including functional representation within teams and committees to attain group goals

• Proven track record and experience in Advertising & Promotional review committees with a thorough understanding of FDA guidance and regulations

• Strong knowledge of electronic document management systems (e.g. Veeva Vault or similar)

• Proficiency in Microsoft Office programs and Adobe Professional

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The annual base salary we reasonably expect to pay is $158,100.00-$216,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.