GRA Global AdPromo Excellence Lead
$122,250–$176,583 year
HybridCambridge, Massachusetts, United States or Morristown, New Jersey, United States
Job Summary
Conduct global promotional and non-promotional material regulatory reviews for assigned business units, including internet websites and social media, while defining minimal quality standards and processes. Advise teams on evolving regulatory requirements, industry trends, and enforcement actions related to pharmaceutical advertising. Lead transversal excellence activities by representing the team in transformation programs, evaluating digital tools and Gen AI use cases, and supporting system and process reviews. Coordinate with regional partners, maintain KPI dashboards, and document best practices and SOP revisions. Assist in preparing stakeholder meeting materials and conduct upskilling sessions on digital initiatives.
Required Qualifications
- BA/BS degree in Pharmaceutical Sciences, Life Sciences, or related discipline
- 2+ years of experience in the biopharmaceutical industry performing regulatory affairs advertising and promotion review
- Good understanding of global codes and standards including ability to review against the EFPIA and IFPMA standards
- Interpret complex clinical data (eg, CSRs, medical publications)
- Possesses sufficient scientific and clinical knowledge to understand disease states, mechanisms of action, clinical trial design, and statistical concepts relevant to the products being reviewed
- Use data and local SmPC to inform compliant messaging
- Understand review standards for branded, disease awareness, and medical congress content
- Foundational understanding of pharmaceutical regulatory concepts
- Clear and professional written and verbal communication
- English (fluent required)
Desired Qualifications
- Experience supporting transversal and/or digital transformation initiatives like Gen AI, Modular Content, Core Claims, and or other MLR programs
- Familiarity with regulatory technology systems such as Veeva
- basic familiarity with digital tools and platforms (e.g., Microsoft Office, SharePoint)
- Eagerness to learn and grow within regulatory affairs and excellence functions
- Strong attention to detail and commitment to quality in all tasks
- Good organizational and coordination skills
- Collaborative mindset with the ability to work effectively within a team
- Adaptable and proactive in a fast-paced, evolving environment
- additional languages beneficial
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