Vertex Pharmaceuticals · 1 day ago

Senior Manager, Advertising Promotion (Remote)

Boston, MA

Full-time

Remote

Senior Level

$133K/yr - $199K/yr

6+ years exp

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Responsibilities

With oversight, serves as Regulatory reviewer for assigned product(s) on Communications Review Committee (CRC) and Medical Review Committee (MRC), and as Regulatory representative on program and other cross-functional teams

Helps to facilitate CRC discussions between Regulatory, Legal, Medical, Commercial and other stakeholders, as applicable

As a Regulatory Reviewer, assesses the regulatory context and provide regulatory interpretations of applicable guidance and/or regulations or regulatory precedents, including requirements related to submission of material to Health Authority

Provides regulatory guidance and support to commercial teams and other stakeholders, with oversight

Provides support for interactions with Health Authorities for assigned product(s)

Works collaboratively in teams to ensure that changes in product labeling are carried into promotional materials in accordance with company procedures and regulatory requirements

Under supervision, participates in the creation and revision of procedures and guidelines related to CRC processes

Monitors advertising and promotion regulations and guidelines to support successful and compliant marketing of Vertex products

Conducts training sessions as needed with stakeholders

Qualification

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Regulatory AffairsHealth Authority regulationsClinical study designStatistical analysisAdvertising compliancePharmaceutical industry experienceRegulatory guidance

Required

Knowledge of applicable Health Authority codes, laws, regulations, guidance, and industry standards related to advertising and promotional communications about prescription drugs and/or devices if applicable

Understanding of clinical study design and statistical analyses in assessment of promotional claims

Interpersonal and communication skills to explain difficult information and to work to build alignment

Ability to work both independently and collaboratively across functions

Pharmaceutical industry and Regulatory Affairs ad/promo experience

Bachelor’s degree in relevant/scientific discipline or a related field

Typically requires 6 years of experience or the equivalent combination of education and experience