Biogen

Associate Director, Regulatory Affairs – Advertising and Promotion

ComplianceComplianceFull TimeRemoteSeniorTeam 5,001-10,000H1B SponsorCompany Site LinkedIn

Location

United States

Posted

51 days ago

Salary

$144K - $206K / year

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

• 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

Job 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

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

Related Categories

Compliance

Related Job Pages

Remote Full-time Jobs (US)More US Remote Jobs

More Compliance Jobs

Managing Director, Public Health Services Helplines

Health Resources in Action Inc

Compliance51 days ago

Full TimeRemote

Health Resources in Action, Inc. (HRiA) is a non-profit organization working to improve and reimagine public health. We connect, consult, and collaborate to solve complex challenges of access and equity in our health and social systems. Together with our partners, clients, and co...

View details: Managing Director, Public Health Services Helplines

United States

Apply

ELL Compliance Coordinator

Stride, Inc.

Making learners future-ready

Compliance51 days ago

Full TimeRemoteTeam 5,001-10,000Since 2000H1B No Sponsor

Company Site LinkedIn

Remote ELL Compliance Coordinator managing school’s English Language Learner program

View details: ELL Compliance Coordinator

Washington

$21 / hour

Apply

Senior GRC Consultant

CDW

CDW is a leading multi-brand provider of information technology solutions to business, government, education and healthcare customers in the United States, the United Kingdom and Canada. A Fortune 500 company and member of the S&P 500 Index, CDW helps its customers to navigate an increasingly complex IT market and maximize return on their technology investments. Together, we unite. Together, we win. Together, we thrive. CDW is an equal opportunity employer. All qualified applicants will receive consideration for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status or any other basis prohibited by state and local law. CDW is committed to fostering an equitable, transparent, and respectful hiring process for all applicants. During our application process, CDW’s goal is to get to know you as an applicant and understand your experience, strengths, skills, and qualifications. While AI can help you present yourself more clearly and effectively, the essence of your application should be authentically yours.

Compliance51 days ago