At Biogen, we are pioneers in neuroscience. 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 Information
The 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
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.
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All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.