Senior Manager, Regulatory Promotion & Material Compliance

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver strategic guidance for product and disease communications and activities by analyzing the current FDA regulatory landscape.

• Guarantee accurate and non-deceptive communication to the healthcare community, patients, and the public.

• Develop and convey the regulatory promotional stance for approved and/or pipeline products.

• Possess promotional review committee experience in assessing proposed materials and supporting evidence.

• Review promotional enforcement activities and evaluate the evolving regulatory environment to understand its implications for Amgen.

• Keep the Promotions group informed about new insights and key takeaways from training sessions, congresses, and tradeshows.

• Provide mentorship to Senior Associate and Manager level reviewers.

• Evaluate promotional programs in relation to Regulatory requirements.

• Identify modifications needed to comply with Promotional Regulations.

⛳️ Requirements

• Doctorate degree with 2 years of relevant experience.

• Or Master’s degree with 4 years of relevant experience.

• Or Bachelor’s degree with 6 years of relevant experience.

• Or Associate’s degree with 10 years of relevant experience.

• Or High school diploma / GED with 12 years of relevant experience.

• Acts as a technical authority on advertising and promotions within the organization.

• Experienced in reading, comprehending, and applying promotional regulations in a dynamic environment.

• Background in situations that necessitate frequent negotiation, persuasion, collaboration, and analytical judgment.

• Proficient in understanding and interpreting data/information and applying it practically.

• Demonstrated leadership capabilities.

• Strategic mindset.

• Team collaboration skills.

• Ability to work independently.

• Clinical knowledge and understanding.

• Strong analytical judgment.

• Negotiation and persuasion expertise.

• Skills in coaching and mentoring.

• Project management capabilities.

• Problem-solving proficiency.

• Time management abilities.

• Organizational skills.

🏝️ 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 feasible.