Manager, Ad Promo & Labeling

Madrigal PharmaceuticalsConshohocken, PA
1d$147,000 - $179,000

About The Position

This position is ideal for mid-level regulatory professionals to join the Regulatory Operations team as a Sr. Regulatory Associate/Manager, Ad Promo & Labeling, managing key regulatory processes and ensuring compliance across global markets for advertisements and promotional materials and labeling. Partnering with cross-functional teams, you'll provide expert regulatory insights and support to ensure compliant product launches and maintain regulatory standards throughout the product lifecycle. This role is crucial in maintaining Madrigal’s regulatory compliance and supporting successful regulatory operations globally.

Requirements

  • Minimum of a Bachelor's degree in a technical or life sciences field.
  • 4 to 6 years of experience in quality or regulatory roles in a regulated industry
  • Experience with Veeva Rim and PromoMats is a plus.
  • Experience with project management is a plus.
  • Excellent presentation and communication skills both virtually and in-person.
  • Ability to work both independently and collaboratively in a global team.

Nice To Haves

  • Strong critical thinking and problem-solving abilities.
  • Attention to detail.
  • Excellent organizational skills.
  • Proficiency in managing multiple tasks and prioritizing effectively.
  • Expertise in labeling and labeling change assessments.
  • Strong technical/computer skills.
  • Outstanding written and verbal communication skills, with the ability to effectively communicate at multiple levels in the organization.
  • Ability to collaborate across cross-functional teams.
  • Independence and self-direction, with a strong desire to work collaboratively as part of a high-performing team.
  • Adaptable and flexible in a fast-paced environment.

Responsibilities

  • Act as the point of contact for all advertisements and promotional material assets, globally and in North America.
  • Review marketing advertisements and promotions for regulatory compliance within the marketing material review platform as systems SME and provide guidance and training on processes as required.
  • Provide guidance on regulatory requirements for processes for creating marketing materials.
  • Access and manage the regulatory assets.
  • Maintain and update Global regulatory requirements labeling reference document.
  • Ensure labeling practices comply with regulatory standards, performing impact and gap assessments for new or revised requirements.
  • Assist with the review, remediation, and/or implementation of regulatory processes.
  • Support the preparation and submission of regulatory documents for Ad Promo and labeling.
  • Participate in internal and external audits, providing necessary documentation and support.
  • Collaborate with cross-functional teams (internal and external) to ensure regulatory compliance across all operations.
  • Contribute to continuous improvement initiatives within the regulatory strategy and operations team.
  • Provide training and support to team members on regulatory requirements and best practices.
  • Maintain up-to-date knowledge of global regulatory standards and requirements.

Benefits

  • Madrigal offers a competitive Total Rewards strategy to attract and retain top talent and is inclusive of base pay, bonus, equity, and a generous benefits package.
  • Full-time employees are eligible for base salary, bonus, equity, and a comprehensive benefits suite.
  • Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans.
  • We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings.
  • In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family.
  • The company also provides other benefits in accordance with applicable federal, state, and local laws.
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