AD Reg Affairs - Ad&Promo

AD Reg Affairs - Ad&Promo
  • Competitive
    HOUR
  • Permanent
  • New York NY, US New York New York US 10004
Job Ref: JO000111723
Sector: Clinical
Sub-sector: Clinical
Date Added: 29 March 2021


Associate Director, Regulator Affairs - Advertising & Promotion

JOB SUMMARY

The Associate Director, Regulator Affairs - Advertising & Promotion will represent the regulatory function on multi-disciplinary Promotional Review Committee and Medical Legal Regulatory Affairs Review Committee. This role will report to the Executive Vice President, Product Strategy.

JOB RESPONSIBILITIES

  • Supporting or conducting interactions with the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) for assigned product(s)
  • Reviewing and approving consumer and professional promotional materials for marketed products, corporate communications, and educational and training materials, via the promotional review committee (PRC) process
  • Acting as the primary Regulatory Advertising & Promotion (A&P) point of contact for the PRC for assigned product(s)
  • Providing strategic regulatory advice on promotional materials and activities, including the development of launch materials/new claims, in accordance with business goals and objectives
  • Contributing to/providing regulatory advisory submission strategies, preparing communications, and overseeing the timely and accurate submission of promotional materials to OPDP for assigned product(s)
  • Maintaining up-to-date knowledge of US regulatory promotional environment and advising internal stakeholders on trends and pertinence to existing company materials/activities
  • Monitoring the competitive landscape to stay abreast of promotional and advertising strategies and activities
  • Reviewing and approving non-promotional scientific and medical communications for development stage products, via the medical/legal/regulatory affairs (MLR) review committee process
  • Providing strategic input during product labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising
  • Collaborating with key stakeholders in areas such as Marketing, Medical Affairs, Corporate Communications, Labeling, and Legal to develop compliant messaging and materials in support of business goals and objectives
  • Developing and updating written departmental guidance and procedures
  • Continually assessing A&P-related processes and procedures to enhance efficiencies and compliance
  • Designing and conducting training for internal employees

REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor's degree in a scientific or pharmacy related field required
  • Advanced degree (MS, MPH, PharmD, PhD, or JD) preferred
  • 8+ years pharmaceutical industry experience with 4+ years in Regulatory Affairs Advertising & Promotion
  • 2+ years of CNS experience preferred
  • Expert knowledge of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, with focus on advertising and promotion
  • Familiarity with labeling regulations
  • Experience working with the FDA, specifically OPDP
  • Excellent project management skills, attention to detail, and ability to manage multiple projects / priorities
  • Ability to recognize potential problems and identify potential solutions
  • Ability to establish and maintain effective working relationships with a diverse range of cross-functional stakeholders
  • Excellent organizational, computer, and documentation skills
  • Ability to meet deadlines and perform multiple tasks in a fast-paced setting
  • Demonstrated personal initiative, responsibility, flexibility, and ability to work under limited supervision
  • Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the department or segments of the organization

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

SRGTalent
30/04/2021 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Melissa Rodrigues

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