Provide 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
Job Summary
Provide 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.
Serve as the primary point of contact with the Office of Prescription Drug Promotion (OPDP) for designated product(s) and ensure promotional materials are consistent with FDA-approved labeling, compliant with applicable FDA regulations, and completed in accordance with 2253 submission requirements.
Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being.
Matching Summary
Provide 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.
Salary
$144,000.00-$206,000.00; Bonus/Equity: cash bonus and equity incentive opportunities; Benefits: Medical, Dental, Vision, & Life insurances, Fitness & Wellness programs, Disability insurance, paid time off, 401(k) program, ESPP, tuition reimbursement
Skills & Requirements
Must-have
U.S. communications review
promotional materials review
disease education materials
medical/scientific materials review
FDA regulations compliance
PhRMA guidelines compliance
Nice-to-have
integrity and agility
solution-oriented feedback
strong working relationships
pioneering spirit
commitment to excellence
Key Requirements
Minimum of 5 years of Regulatory promotional review