Career CategoryRegulatory
Job DescriptionRegulatory Affairs Sr Manager, Regulatory Promotion & Material ComplianceWhat you will doLet'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.
Key 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
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications: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
Preferred Qualifications:- 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
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- 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. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
SponsorshipSponsorship for this role is not guaranteed.
Salary Range142,579.00USD -192,901.00 USD
