Associate Director, Regulatory Advertising Promotion, Pain

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver strategic and tactical regulatory support and guidance for communications related to products and disease states within the Pain program.

• Collaborate with cross-functional teams and oversee the regulatory review and approval process for communications and related activities.

• Act as the regulatory reviewer for designated products on the Communications Review Committee and Medical Review Committee.

• Represent Global Regulatory Affairs Advertising and Promotion on program and cross-functional teams.

• Potentially lead Communications Review Committee meetings and facilitate stakeholder discussions to achieve consensus decisions.

• Ensure that regulatory requirements are incorporated into product and disease-state communications.

• Evaluate the regulatory context and interpret relevant guidance, regulations, and regulatory precedents.

• Assist in the submission of materials to Health Authorities and engage with them as necessary.

• Offer guidance for developmental products while considering promotional requirements.

• Ensure that labeling changes are accurately reflected in promotional materials in accordance with procedures and regulations.

• Collaborate on the creation and updating of Communications Review Committee procedures and guidelines.

• Monitor and interpret regulations and guidelines concerning advertising and promotion.

• Plan and conduct training sessions for stakeholders as required.

⛳️ Requirements

• Bachelor’s degree in a relevant or scientific discipline, or a related field.

• Typically requires 5-7 years of experience or a combination of education and experience that equates to this.

• Comprehensive knowledge of relevant Health Authority codes, laws, regulations, guidance, and industry standards regarding advertising and promotional communications for prescription drugs, devices (if applicable), and investigational treatments.

• Profound understanding of clinical study design and statistical analyses in evaluating promotional claims.

• Excellent interpersonal and communication skills to convey complex concepts and influence others effectively.

• Capability to innovate, analyze, and resolve issues.

• Experience in the pharmaceutical industry and regulatory advertising/promotion, including interactions with health authorities.

• Experience in pain, analgesia, and/or neurology is highly preferred.

• Ability to work remotely with East Coast working hours.

• No C2C or Third-Party Vendors accepted.

🏝️ Benefits

• Contract duration through July 2027 with the possibility of extension.

• Overtime compensation in alignment with federal and state regulations.

• Compensation, medical benefits, fringe benefits, and other terms and conditions will be provided by the third-party agency partner upon offer.