Biogen · 1 day ago
Associate Director, Reg Ad Promo
United States
Full-time
Remote
Lead/Staff, Director/Executive
$150K/yr - $206K/yr
5+ years expBiogen is a pioneering company in neuroscience, seeking an Associate Director to provide regulatory strategic advice for U.S. communications related to disease education and promotional materials. The role involves collaboration with cross-functional teams to ensure compliance with FDA regulations and effective communication of materials.
BiotechnologyHealth CareNeuroscienceTherapeutics
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
Qualification
Required
BS required; advanced degree preferred
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
Benefits
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation
Company
Biogen
Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
Founded in 1978Cambridge, Massachusetts, USA
5001-10000 employees
H1B Sponsorship
Biogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)
Funding
Current Stage
Public CompanyTotal Funding
$1.5BKey Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO
Leadership Team
Robin C. Kramer
Executive Vice President, Chief Financial Officer
Priya Singhal
Executive Vice President, Head of Development
Recent News
Pharmaceutical Technology
2026-01-05
thecanadianpressnews.ca
2025-12-24
Company data provided by crunchbase