Associate Director, Reg Ad Promo

Biogen

About The Position

At Biogen, we are pioneers in neuroscience. The role of Associate Director requires the ability to 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. The role may also require review of global, corporate, clinical trial, and pipeline materials and communications. This individual will effectively partner and collaborate with cross-functional stakeholders and ensure that materials are competitive and compliant with applicable FDA regulations, PhRMA guidelines, and Biogen policies.

Requirements

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

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

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