Director, Regulatory Advertising and Promotion

ComplianceComplianceFull TimeRemoteLeadTeam 1,001-5,000Since 1991H1B No SponsorCompany SiteLinkedIn

Location

Massachusetts

Posted

115 days ago

Salary

$175K - $235K / year

Seniority

Lead

Bachelor Degree10 yrs expEnglish

Job Description

• Responsible for providing strategic and tactical regulatory ad promo support and guidance related to product and disease state communications for assigned product(s) or therapeutic area across the product life cycle. • Collaborates extensively with cross-functional teams to ensure that promotional communications are compliant and meet business objectives. • Serves as the primary liaison with the FDA’s office of prescription Drug Promotion (OPDP). • Reports to the Global Head of Regulatory Advertising and Promotion and accounts for the review and approval of US promotional and non-promotional communications of assigned product(s). • Contributes to the ongoing development of a best-in-class Regulatory Advertising and Promotion team.

Job Requirements

  • Minimum Bachelor’s Degree in a scientific or healthcare-related field
  • Minimum 10 years of related biopharma experience
  • Advanced scientific degree (MD, PharmD, PhD) or Juris Doctor with a minimum of 8 years related biopharma experience preferred
  • Minimum of 8 years of regulatory experience in the pharmaceutical industry
  • Minimum of 5 years of regulatory AdPromo experience
  • Expert knowledge of FDA prescription drug regulations, policies, guidances, and enforcement trends
  • Experience in supporting product launch required
  • DTC broadcast ads experience highly desirable
  • Strong leadership skills including ability to collaborate across all levels of the organization in achieving sound business decisions
  • Good understanding of clinical study design and statistical analyses in assessment of proposed promotional claims
  • Understanding of drug development and labeling
  • Experience in Rare Diseases, Immunology, and/or Hematology a plus
  • Strong interpersonal and communication skills with the ability lead with or without direct authority.
  • Foster a culture of compliance, innovation, accountability, and continuous learning
  • Ability to innovate, analyze, and solve problems.

Benefits

  • Competitive compensation for your work
  • Generous time off policy
  • Summer Fridays
  • Opportunity to broaden your horizons by attending popular conferences
  • Emphasis on work/life balance
  • Collaborative and team-oriented environment
  • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

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