US Regulatory Advertising and Promotion Reviewer

Employer
Lilly
Location
Indianapolis, Indiana
Salary
Competitive
Posted
June 15 2019
Ref
48973BR
Discipline
Life Sciences
Position Type
Full Time
Organization Type
Pharma
Job Type
Other
Provide Regulatory expertise with US Brand Teams and alliance companies (70% of time, includes #1, 2, 3, 4 and 5)
  • Accomplished by working with teams to ensure
    1. Compliance with all applicable regulations, internal policies and quality systems
    2. High quality, timely and decisive regulatory advice to allow business partners to make well-informed decisions
    3. Development of promotional messages that educate customers about the benefits and risks of Lilly products by introducing multiple alternative approaches that may meet the business objectives while maintaining compliance with applicable regulations and internal policies
  • Support implementation of the Customer Information Quality (CIQ) system, including development and review of claims, product and disease state communications within the CIQ processes, timely completion of impact assessments for deviation management, input into change controls, and quality review of promotional material submissions to FDA.
For example:
  1. Ensure regulatory requirements are met for projects in the Prepare, Create and Approve process
  2. Advise on strategy to implement labeling changes, including important safety information revisions
  • Provide regulatory guidance during product labeling reviews, including impact on promotional communications
  • Attend US Brand Team meetings regularly and participate actively in making recommendations regarding proposed promotional activity plans
  • Develop relationships with personnel in other Lilly functional areas (i.e., marketing, medical, legal, labeling, compliance, quality etc.) to effectively influence the implementation of appropriate promotional messages
  • Constructively challenge teams to reach the best solutions to issues. Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues
  • Communicate both in written and oral form with regulatory and US Brand team leadership
  • Develop collegial, mutually productive relationships with OPDP to enable Lilly to negotiate mutually beneficial solutions to identified issues
  • Partner with OPDP project managers and regulatory reviewers to carefully prepare for and organize meetings, teleconferences and other communications, including requests for advisory comments. Provide required documents, planning details and follow-up notes in a punctual manner.
  • Develop therapeutic area regulatory expertise to drive internal consistency and external awareness related to commercialization activities
Provide Regulatory expertise with Global Marketing Teams, Global Business Communications and Global Medical Affairs (70% of time, includes #1, 2, 3, 4 and 5)
  • Accomplished by working with teams to ensure
    1. Compliance with all applicable regulations, internal policies and quality systems
    2. High quality, timely and decisive regulatory advice to allow business partners to make well-informed decisions
    3. Development of communications that educate customers about the benefits and risks of Lilly products by introducing multiple alternative approaches that may meet the business objectives while maintaining compliance with applicable regulations and internal policies
  • Provide Regulatory guidance for market research and global launch campaign development
  • Provide Regulatory guidance for promotional press materials and scientific disclosures to media customers
  • Provide Regulatory guidance for digital Lilly medical communications, proactive presentations by medical affairs, and exhibit booth for scientific Congresses
Serve as key subject matter expert with Regulatory peers and business partners on topic(s) relevant to external medical product communications (70% of time, includes #1, 2, 3, 4 and 5). This is accomplished by:
  • Actively monitoring external environment for updates on topic(s)
  • Periodically share updates by presentation or summary reports
  • Provide ad hoc consultation
  • Engage in external forums, including conferences
Provide Leadership for Teams (70% of time, includes #1, 2, 3, 4 and 5). This is accomplished by:
  • Taking a proactive leadership role in the critical review of promotional strategies for product
  • Establishing trust and credibility through superior regulatory knowledge and influencing others in a manner that creates maximum advantage for the organization
  • Managing assertively to meet timelines and elevate productivity throughout the development of promotional materials by setting priorities, finding innovative ways of doing essential work, improving quality and capitalizing on continuous improvement efforts, as appropriate
  • Taking leadership in ensuring the success of our business partnerships
  • Serving as a mentor for GRA-US advertising and promotion personnel and others in GRA
Achieve Results with People (70% of time, includes #1, 2, 3, 4 and 5). This is accomplished by:
  • Encouraging team members as they perform their functional responsibilities and provide relevant information that will help enhance their performance
  • Sharing with team current issues with OPDP
  • Strategizing with team marketing and clinical plans
  • Sharing learning regarding the practical implementation of the advertising regulations with regulatory colleagues
  • Participating in forums that share regulatory information across GRA components
  • Expanding opportunities across therapeutic area to build competitive intelligence efforts related to promotion and advertising
  • Integrating knowledge, expertise and negotiation skills to solve problems, modify procedures and interpret policy to meet new conditions
  • Modeling the innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.
Lead development of risk mitigation strategies for US product promotion (20% of time). This is accomplished by:
  • Ongoing monitoring and communicating factors and trends in the external environment related to advertising and promotion topics from OPDP enforcement actions
  • Advise business partners on impact of new OPDP Guidances and OPDP social scientist research publications to promotional activities and practices
  • Communicating learning through Lilly interactions with OPDP to US Brand Teams, including leadership and cross-functional participants in promotional material process
  • Supporting implementation of internal promotional guidelines and standards
Exercise accountability for knowledge transfer across GRA (10% of time). This is accomplished by:
  • Partnering with Regulatory Research Scientists from GRA to consider FDA Review Division perspectives and relevant regulatory history in advertising decisions
  • Engaging with GRA labeling experts to develop strategy on product labeling components that appropriately balances consideration of business implication and regulatory compliance
  • Developing an understanding regarding the background of regulatory and marketing history of applicable product(s)
  • Regularly communicating with other components in the GRA organization (i.e., labeling, central registration, regulatory intelligence) to facilitate sharing of information that allows the entire component to more effectively support pre- and post-approval teams
  • Being recognized as a technical expert in a specific area, product/class or a functional area
  • Attending internal and external training programs, such as GRA-US staff meetings, DIA, FDLI and RAPS meetings


Company Overview

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Basic Qualifications

  • Bachelor's Degree
  • Regulatory Advertising and Promotion experience required
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position


Additional Information

The purpose of the Consultant Regulatory role is to lead and facilitate effective partnerships with the US Brand Teams, Global Marketing, Global Business Communications, and Global Medical Affairs in order to provide regulatory guidance in the development of medical product communications that educate healthcare professionals, patients and payers about the benefits and risks of Lilly products. In addition to working with a team of regulatory personnel and other cross-functional partners from Lilly, the Consultant also collaborates with regulatory personnel and other team members from alliance partner companies. To accomplish this purpose, it is necessary for the Consultant to develop collegial and mutually productive relationships across Lilly components, partner company components, and with the FDA's Office of Prescription Drug Promotion (OPDP). Additionally, the Consultant supports the preparation and implementation of interactions with OPDP. Based on these relationships and thorough understanding of the prescription drug advertising regulations, the Consultant is expected to actively engage in company medical product communications decisions to assure compliance. The Consultant must also monitor and communicate key events in the external environment that have the potential to impact communication practices. The Consultant utilizes therapeutic area regulatory expertise and lessons learned across a therapeutic area to drive internal consistency and influence effective change management with brand team and other leadership.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Additional Skills/Preferences

  • Industry-related experience in drug development and/or commercialization
  • Knowledge of FDA procedures and practices (CFR guidelines, Guidance's, etc.)
  • Awareness of evolving regulatory reform initiatives and pending changes (Federal Register, media reports, etc.)
  • Knowledge of drug development process, Lilly regulatory/business strategies and plans
  • Demonstrated ability to influence without authority and ability to deliver complex projects against a timeline.
  • Strong communication skills (active listening, verbal, and written)
  • Demonstrated ability to apply systematic thinking/mindset to business problems and opportunities
  • Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles

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