Ionis Pharmaceuticals, Inc. · 2 days ago

Executive Director, Regulatory Advertising/ Promotion Compliance

United States

Full-time

Remote

Director

$230K/yr - $294K/yr

12+ years exp

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Responsibilities

Lead and manage the Ionis Global Regulatory Advertising/Promotional Team members.

Review US promotional, disease awareness, public affairs and medical materials and ISTs, attends promotional review meetings and provides regulatory guidance to the cross-functional team responsible for ensuring material compliance with global compliance standards and FDA regulations pertaining to prescription drug advertising and promotion, as applicable

Manage and oversee review of medical and promotional materials outside of the US including managing any external third parties used for ex-US reviews

Serves as primary contact for communications with the Office of Prescription Drug Promotion (OPDP) or Advertising and Promotional Labeling Branch (APLB) for assigned products, including responsibilities for the timely preparation and submission of promotional materials under cover of FDA Form 2253

Develop Standard Operating Procedures (SOP) (and other relevant controlled documents) and assist with cross-functional SOP development as needed as it pertains to medical materials and promotional materials review process.

As needed, provides training support on regulatory requirements for prescription drug promotion including, but not limited to, sales training and compliance training in preparation for scientific conferences

Maintains accurate files of labeling change history and associated documents, including annotated labels back to source data.

Contributes to the development of continuous improvement of business practices associated with AD/Prom processes and tools.

Qualification

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Drug DevelopmentGxPGCPICHFDAEMEANICERisk AssessmentCompliancePharma AdvertisingProblem-SolvingInterpersonalCommunicationLeadershipRAC Certification

Required

Solid working knowledge of U.S. advertising/ promotional and regulations with additional experience with global standards for advertising and promotion preferred

Direct experience in management of direct reports

Direct experience communicating and negotiating directly with Regulatory Authorities

Demonstrated understanding of regulations, processes and issues in drug development. Includes GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH, FDA, EMEA, NICE and other relevant guidelines

Proven track record practicing sound judgment as it relates to risk assessment

Knowledgeable on industry compliance requirements and non-compliance examples and trends

Demonstrated ability to influence others and foster team collaboration

Strong interpersonal, communication and leadership skills

Proven ability to prioritize and meet critical business timeline

Bachelors’ Degree, Master’s Degree preferred

At least 12+ years of pharma advertising and promotion experience