Biogen
Associate Director, Regulatory Affairs Advertising and Promotion
Biogen, Myrtle Point, Oregon, United States, 97458
Overview
Salary up to $206,000.00
Opportunity for career advancement and growth within a pioneering biotechnology company
Comprehensive benefits package including medical, dental, vision, and life insurance
Generous paid time off policy including a minimum of 15 days of vacation and additional holidays
Supportive work environment that values inclusion and diversity
Participation in employee resource groups and tuition reimbursement up to $10,000 per year
Responsibilities
Provide regulatory strategic input and risk assessment for promotional and medical communications
Serve as the primary contact with the Office of Prescription Drug Promotion (OPDP) for designated products
Ensure compliance of promotional materials with FDA regulations and submission requirements
Develop strong working relationships with cross-functional teams including Commercial, Medical, and Legal
Assist in monitoring the evolving regulatory landscape and communicate updates to stakeholders
Qualifications
BS degree required; advanced degree preferred
Minimum of 5 years of experience in regulatory promotional review
Detail-oriented with strong organizational skills
Ability to analyze risk and communicate effectively across teams
Exceptional verbal, written, and presentation skills
Preferred Qualifications
Experience in a fast-paced and compliant environment
Proven negotiation and interpersonal skills to influence and build collaboration
Familiarity with complex disease information and product efficacy/safety data
#Biotechnology #RegulatoryAffairs #CareerOpportunity #CompetitivePay #DiversityAndInclusion
We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.
We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
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Salary up to $206,000.00
Opportunity for career advancement and growth within a pioneering biotechnology company
Comprehensive benefits package including medical, dental, vision, and life insurance
Generous paid time off policy including a minimum of 15 days of vacation and additional holidays
Supportive work environment that values inclusion and diversity
Participation in employee resource groups and tuition reimbursement up to $10,000 per year
Responsibilities
Provide regulatory strategic input and risk assessment for promotional and medical communications
Serve as the primary contact with the Office of Prescription Drug Promotion (OPDP) for designated products
Ensure compliance of promotional materials with FDA regulations and submission requirements
Develop strong working relationships with cross-functional teams including Commercial, Medical, and Legal
Assist in monitoring the evolving regulatory landscape and communicate updates to stakeholders
Qualifications
BS degree required; advanced degree preferred
Minimum of 5 years of experience in regulatory promotional review
Detail-oriented with strong organizational skills
Ability to analyze risk and communicate effectively across teams
Exceptional verbal, written, and presentation skills
Preferred Qualifications
Experience in a fast-paced and compliant environment
Proven negotiation and interpersonal skills to influence and build collaboration
Familiarity with complex disease information and product efficacy/safety data
#Biotechnology #RegulatoryAffairs #CareerOpportunity #CompetitivePay #DiversityAndInclusion
We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.
We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
#J-18808-Ljbffr