Senior Manager, Regulatory Promotion & Material Compliance

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $142.6k - $192.9k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $28.5G Post-IPO Debt on 2022-12

Biotechnology • Pharmaceuticals • Science

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Provide strategic direction for product and disease communications and activities by interpreting current FDA regulatory environment • Ensure truthful and non-misleading communication to health care community, patients, and the public • Formulate and communicate the regulatory promotional position for approved and/or pipeline products • 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 • Assess promotional programs against Regulatory requirements • Identify changes required to meet Promotional Regulation

🎯 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 • 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

🏖️ 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 • flexible spending accounts • A discretionary annual bonus program • stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible.