_Who We Are:_
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit _neurocrine.com_, and follow the company on _LinkedIn_, _X_ (formerly Twitter), _Facebook_ and _YouTube_. (_*in collaboration with AbbVie_)
_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.
_Your Contributions (include, but are not limited to):_
- Leads the PRC process for assigned products to ensure compliance with FDA advertising and promotional regulations and guidelines for promotional, disease state, and medical education materials
- Represents Regulatory Affairs on the Medical Review Committee (MRC) and conducts regulatory review of materials intended for use by field medical teams
- Independently reviews advertising and promotional materials and provides clear, risk-based regulatory guidance by integrating scientific, regulatory, and business considerations
- Responsible for timely and accurate review and submission of promotional materials, including FDA Form 2253 submissions
- Evaluates FDA guidance, policies, enforcement trends, and the overall regulatory environment to assess and communicate potential regulatory risk and impact
- Fosters strong cross-functional partnerships between Regulatory Affairs and PRC partner functions to support compliant and effective promotional review and approval processes
- Ensures communications and promotional claims comply with approved product labeling, applicable laws, internal policies, and external regulations
- Navigates complex cross-functional discussions and operates independently while appropriately seeking strategic alignment on highly complex, novel, or high-risk issues
- Continually assesses advertising and promotion-related processes and procedures to enhance efficiency, consistency, and compliance and recommends or implements improvements as appropriate
- Maintains standard operating procedures and department working practices
- May mentor and develop more junior team members
- Other duties as assigned
_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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Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.
