About this Role:

As the Director of Regulatory Advertising and Promotion you are empowered to provide strategic and tactical regulatory leadership and support for the review and approval of product, pipeline, and disease state communications, including promotional and non-promotional materials and communications from various stakeholders across the company. You will work collaboratively and demonstrates cross-functional leadership in the development and implementation of processes that support meeting business objectives and that are compliant in relation to regulatory requirements and company policies.

What You’ll do:

•         Actively contribute to the development and implementation of Global Regulatory Ad Promo strategy for promotional labeling and other communications including social media, press releases and corporate talking points

•         Provide direction and expertise as a Regulatory expert on regulations and requirements governing product promotion, corporate, patient advocacy, disease education, and investigational drug communications and materials

•         Facilitate alignment and consistency in the Regulatory Ad Promo team’s application of company policies across therapeutic areas and brands, considering the totality of product-related and company activities

•         Serve as Regulatory Ad Promo Head for assigned therapeutic areas including representation on global commercial product/program communication teams and global regulatory program teams

•         Provide regulatory representation to early-stage programs, including review of scientific and clinical trial recruitment materials as needed

•         Enhance collaboration across matrixed organization by providing Regulatory Ad Promo feedback and rationale at assigned therapeutic area meetings, labeling meetings, global and US brand team meetings

•         Actively contribute to the development and implementation of regulatory training programs for cross-functional partners company-wide

•         Analyze and interpret data in accordance with applicable regulatory requirements and guidance

•         Supervise and provide development opportunities for direct reports

•         Point of contact with OPDP and lead coordination of OPDP submissions for subpart E&H products as needed

Who You Are

We are seeking a highly motivated and experienced individual who can lead without authority and have a meaningful impact at Biogen and in the Global Regulatory Advertising & Promotion department. You are a positive individual who demonstrates integrity and agility while working in fast-paced and compliant environment to advance external HCP, payor, and patient initiatives. You consistently manage and prioritize multiple and competing responsibilities for an expanding business that strives to meaningfully change the lives of people living with serious neurological diseases. 

Required Skills:

•         Minimum 8+ years pharmaceutical/Biotechnology industry experience, 6+ years regulatory advertising and promotion experience.

•         High level of applied knowledge and of applicable FDA laws, regulations, guidance, and industry standards related to advertising and promotional communications about prescription drugs, devices (if applicable), and investigational drugs

•         In-depth understanding of clinical study design and statistical analyses in assessment of potential claims

•         A solutions-driven mindset, including problem-solving, complex reasoning, and risk management assessments

•         Excellent communications skills (oral and written), project management and presentation skills

•         Ability to work both independently with minimal direction and within teams to attain group goals.

•         Demonstrate effective cross-cultural awareness and capabilities.

•         Demonstrate strong organizational skills, including the ability to prioritize workload.

•         Build relationships with cross-functional stakeholders with a variety of staff including commercial, medical, scientific and manufacturing staff.

•         Knowledge and understanding of applicable regulations.

•         Direct experience with regulatory agencies

#LTD-1

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.