Associate Director, Reg Ad Promo

Role Summary

Associate Director, Reg Ad Promo provides regulatory strategic advice primarily for U.S. communications related to disease education, promotional materials, and medical/scientific materials for healthcare providers, payors, and patients in support of Biogen business objectives. The role may also review global, corporate, clinical trial, and pipeline materials. Partners with cross-functional stakeholders to ensure materials are competitive and compliant with applicable FDA regulations, PhRMA guidelines, and Biogen policies.

Responsibilities

• Provide regulatory strategic input, risk assessment, and mitigation strategies to various global and U.S. internal teams on branded and unbranded concepts, promotional materials, disease awareness communications, medical communications and sales training/education materials
• Provide creative and solution-oriented feedback to meet business goals and further business objectives
• Serve as the primary point of contact with the Office of Prescription Drug Promotion (OPDP) for designated product(s)
• Ensure promotional materials are consistent with FDA-approved labeling, compliant with applicable FDA regulations, and completed in accordance with 2253 submission requirements
• Develop and maintain strong working relationships with internal colleagues including, but not limited to: Commercial, Medical, Legal, Compliance, Regulatory Strategy and Labeling, and Medical/Marketing Operations
• Work with management and Reg AP team members to ensure communications and feedback are generally consistent across franchises
• Assist Regulatory Ad Promo department in monitoring evolving regulatory landscape and communicating updates to internal stakeholders

Qualifications

• Minimum of 5 years of Regulatory promotional review
• Detail and deadline oriented; well organized
• Capability to analyze and assess risk and then effectively communicate across interdisciplinary teams
• Ability to dissect and interpret complex disease information and product efficacy/safety data
• Demonstrates strong negotiation and interpersonal skills to influence others and build team collaboration, consensus and partnerships
• Adapts to dynamic environment and business needs
• Ability to develop and maintain relationships with OPDP
• Excellent verbal, written, and presentation skills

Skills

• BS required; advanced degree preferred

Education

• BS required; advanced degree preferred