Job Description

Career Category Regulatory

ABOUT AMGEN
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
ABOUT THE ROLE
The Manager of Regulatory Promotions Operations supports the US Based Regulatory Promotions and Material Compliance team by leading the AIN based Associates and Sr Associates in providing seamless operations of critical Regulatory Promotions and Material Compliance (RPMC) services required for Amgen's USBO Region. RPMC services include the preparations of 2253 packages for US promotional content that will be sent to Submission Publishing for FDA submission, Pre-Clearence Submission content preparation, US Label Update Commercial Process, Digital Asset Management Archiving of Global promotional content, Global Digital Site Registry Audit Requests. The role will work closely with US based RPMC Business Process Owners on meeting the timelines tied to the USBO business calendar (E.G. Product Launches, New Indications, etc.).
Roles & Responsibilities:

• Manages 10 Staff of Associates and Sr. Associates responsible for the core services
• Preform staff mid-term and annual performance review and annual goal setting
• Manges staff performance
• Ensure business continuity by managing the onboarding and offboarding processes for transitioning staff

• Oversee staff resource allocation and assignments and ensures that all Service Level Agreements (SLAs) are meeting or exceeding their targets
• Responsible for annual workforce planning based on expected USBO demand
• Ensures process consistency across all services provided
• Trains staff on new procedures and system functions as they are rolled out across the RPMC department
• Provide Project Management support to key initiatives or continuous improvement projects.
• Collaborate with leaders to identify skill gaps and performance improvement opportunities
• Establish a vision for fostering a culture of continuous learning and development

Required Knowledge and Skills:

• Deep experience in leading
• Coaching, Mentoring and Counseling
• Ability to be flexible and manage change
• Regulatory requirements
• Scheduling
• Project Management
• Change Management
• Problem solving
• Excellent written/oral communication skills and attention to detail
• Must demonstrate strong leadership skills in a team environment which requires negotiation, persuasion, collaboration, and compliance judgment
• Proven experience with Veeva PromoMats system including the
• Proven experience in leading a team with multi service operations with the ability to step in an help their team when needed.

Preferred Knowledge and Skills:

• Deep understanding of Pharmaceutical promotional Medical, Legal, Regulatory (MLR) review process and compliance requirements
• Strong skill in the use of the Veeva PromoMats System
• Deep understanding of good compliance practices

Basic Education and Experience:
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
Preferred Education and Experience:

• Bachelor or Mater Degree with the relevant experience
• Experience working in a Regulatory Promotions of Marketing Operations organization

AIN working hours for this position:
This position supports the Regulatory Promotion and Material Compliance activities serving Amgen's US Business Operations and thus the AIN working hours will need to be flexible with occasional overnight work time when needed to support product launches and new indications.
EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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