The role of the 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 and guidances, PhRMA guidelines, and Biogen policies.
What You'll Do - 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 strategic input on promotional claims implications to various global and U.S. internal teams responsible for late-stage clinical development plans
- 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)
- Provide strategic advice for the development of Advisory Comments submissions
- 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
Who You Are Positive individual who demonstrates integrity and agility while working in fast-paced and compliant environment to advance external HCP, payor, and patient initiatives. Consistently manages and prioritizes multiple and competing responsibilities for an expanding business that strives to meaningfully change the lives of people living with serious neurological diseases.
Required Skills - BS required; advanced degree preferred
- Minimum of 4-5 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
Job Level: Management
Additional InformationThe base compensation range for this role is: $152,000.00-$209,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, 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; including, but not limited to:
- 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
Job Level: Management
