Associate Director – Promotion Compliance and Scientific Messaging
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full-time
Posted on:
Location Type: Hybrid
Location: Deerfield • Illinois • United States
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Salary
💰 $185,000 - $215,000 per year
Job Level
About the role
- Ensure compliant and effective promotion and scientific messaging of Lundbeck’s U.S. pharmaceutical products
- Provide regulatory strategic and promotional direction to support product launches
- Manage, review and represent regulatory perspectives at promotional review meetings
- Identify risk, problem-solve, and deliver solution-oriented strategies
- Provide Regulatory strategic guidance on new commercial concepts
- Provide Regulatory promotional and scientific communication leadership on brand and life cycle management teams
- Monitor the external regulatory climate to inform internal customers of potential impact
- Develop and facilitate improvement efforts for internal promotional material review processes
Requirements
- Accredited bachelor’s degree
- 8+ years of experience in Regulatory, R&D or related area within the pharmaceutical, biotech or medical device industry
- At least 4 years within either advertising/promotion or Regulatory experience specific to neurology, migraine or biologics
- Well versed in FDA Promotional Regulations
- Experience in the review of technical content and assessment of product claim feasibility
- Expertise in navigating FDA interactions
- Proficiency in identifying regulatory risk and negotiating/resolving differences
- Demonstrated leadership capabilities as leading by influence
- Attention to detail and strong organizational skills
- Excellent oral and written communication skills
- High proficiency in MS Word, MS Excel and Adobe Acrobat
- Proficient in Veeva or comparable document management system
- High Proficiency in time management and demonstrated ability to work independently
Benefits
- flexible paid time off (PTO)
- health benefits to include Medical, Dental and Vision
- company match 401k
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Regulatory experiencePromotional reviewTechnical content reviewProduct claim feasibility assessmentFDA Promotional RegulationsRegulatory risk identificationNegotiationLeadershipTime management
Soft Skills
Problem-solvingSolution-oriented strategiesAttention to detailOrganizational skillsOral communicationWritten communicationInfluence
Certifications
Accredited bachelor's degree