Associate Director, Regulatory Advertising Promotion, Pain

🔥 15 hours ago

🇺🇸 United States – Remote

💵 $105 - $110 / hour

⏳ Contract/Temporary

🟠 Senior

🚔 Compliance

Where this job comes from

Posted on Vertex Pharmaceuticals's careers page, not through a job board

First seen by Remote Rocketship 15 hours ago

Still open on Vertex Pharmaceuticals's site. Checked 1 hour ago.

Logo of Vertex Pharmaceuticals

Vertex Pharmaceuticals

1001 - 5000 employees

Founded 1989

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Vertex Pharmaceuticals is a global biotechnology company focused on creating transformative medicines for people with serious diseases. With a commitment to scientific innovation, Vertex engages in the discovery, development, and production of cutting-edge therapies, particularly for conditions such as cystic fibrosis, sickle cell disease, and pain management. The company also emphasizes corporate responsibility and diversity within its inclusive culture to drive innovation and improve patient lives.

📋 Description

• Provide strategic and tactical regulatory support and guidance for assigned product and disease-state communications supporting the Pain program • Work with cross-functional teams and manage regulatory review and approval of communications and activities • Serve as regulatory reviewer for assigned products on Communications Review Committee and Medical Review Committee • Represent Global Regulatory Affairs Advertising and Promotion on program and cross-functional teams • Potentially chair Communications Review Committee meetings and lead stakeholder discussions to reach consensus decisions • Ensure regulatory requirements are integrated into product and disease-state communications • Assess regulatory context and interpret applicable guidance, regulations, and regulatory precedents • Support submission of materials to Health Authorities and interact with Health Authorities as applicable • Provide guidance for development products considering promotional requirements • Ensure labeling changes are reflected in promotional materials according to procedures and regulations • Collaborate on developing and updating Communications Review Committee procedures and guidelines • Monitor and interpret advertising and promotion regulations and guidelines • Plan and conduct stakeholder training sessions as needed

🎯 Requirements

• Bachelor’s degree in relevant/scientific discipline or a related field • Typically requires 5-7 years of experience or the equivalent combination of education and experience • Thorough knowledge of applicable Health Authority codes, laws, regulations, guidance, and industry standards related to advertising and promotional communications about prescription drugs, devices (if applicable), and investigational treatments • In-depth understanding of clinical study design and statistical analyses in assessment of promotional claims • Strong interpersonal and communication skills to communicate difficult concepts and persuade others • Ability to innovate, analyze, and solve problems • Pharmaceutical industry and regulatory ad/promo experience, including interacting with health authorities • Experience in pain, analgesia, and/or neurology highly preferred • Remote capable with East Coast working hours • No C2C or Third-Party Vendors

🏖️ Benefits

• Contract through July 2027 with chance to extend • Overtime pay in accordance with federal and state requirements • Compensation, medical benefits, fringe benefits and other terms and conditions presented by the third-party agency partner upon offer

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