Director, Regulatory Advertising and Promotion
Sobi - Swedish Orphan Biovitrum AB (publ)
full-time
Posted on:
Location Type: Remote
Location: Remote • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $175,000 - $235,000 per year
Job Level
Lead
About the role
- 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.
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory experienceFDA prescription drug regulationspromotional communications complianceclinical study designstatistical analysesproduct launch supportregulatory AdPromo experiencedrug developmentlabelingbiopharma experience
Soft skills
leadership skillscollaborationinterpersonal skillscommunication skillsproblem-solvinginnovationaccountabilitycontinuous learningability to lead without authoritystrategic thinking
Certifications
Bachelor’s DegreeMDPharmDPhDJuris Doctor