Regulatory Affairs Sr Manager, Regulatory Promotion & Material Compliance

Amgen • Thousand Oaks, CA

6h

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Regulatory Affairs Sr Manager, Regulatory Promotion & Material Compliance What you will do Let’s do this. Let’s change the world. In this vital role you will provide strategic direction for product and disease communications and activities by interpreting current FDA regulatory environment to ensure truthful and non-misleading communication to health care community, patients, and the public. This position is primarily responsible to formulate and communicate the regulatory promotional position for approved and/or pipeline products.

Requirements

• Doctorate degree and 2 years of related experience Or Master’s degree and 4 years of related experience Or Bachelor’s degree and 6 years of related experience Or Associate’s degree and 10 years of related experience Or High school diploma / GED and 12 years of related experience

Nice To Haves

• Serves as an advertising and promotions technical authority within the organization
• Experience in reading, understanding, and applying promotional regulations to a constantly changing environment
• Experience in an environment which requires extensive daily examples of negotiation, persuasion, collaboration, and analytical judgment
• Experience understanding and interpreting data/information and its practical application
• Leadership
• Strategic focus
• Collaboration
• Independence
• Clinical knowledge/understanding
• Analytical judgment
• Negotiation/persuasion skills
• Coaching and mentoring skills
• Project management skills
• Problem solving skills
• Time management skills
• Organization

Responsibilities

• Promotional review committee experience in evaluating proposed pieces and supporting evidence
• Evaluate promotional enforcement activities and assess the changing regulatory environment to determine impact on Amgen
• Update the Promotions group on new learning’s and key takeaways from courses, congresses, and tradeshows
• Mentor Senior Associate and Manager level reviewers
• Assesses promotional programs against Regulatory requirements
• Identifies changes required to meet Promotional Regulation

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed