Advertising and Promotional Compliance Consultant

Medasource; Boston (MA); Sur place; USD 190 000 - 230 000; Plein temps

Résumé du poste

Medasource is seeking the Director, US Advertising and Promotional Compliance to lead regulatory review of promotional content for assigned products in the US market. You will ensure materials meet FDA requirements and corporate standards across promotion, disease awareness and public affairs communications.

You will partner with cross-functional teams, develop processes for review and approval, mentor colleagues, and serve as the primary liaison with FDA offices on ad/promo matters.

Qualifications

• Review and approve regulatory content for product promotion.
• Provide regulatory guidance to cross-functional teams.
• Liaise with FDA offices on promotional issues.
• Develop processes for creation and approval of promotional materials.
• Lead and mentor ad/promo colleagues.

Responsabilités

• Review US promotional materials for compliance with FDA rules.
• Serve as primary contact for OPDP/APLB for assigned products.
• Develop SOPs and best practices for advertising material review.
• Provide training on prescription drug promotion requirements.
• Advise product teams on advertising and promotion issues.
• Keep regulatory expertise current with FDA actions and conferences.
• Support and mentor ad/promo colleagues.

Connaissances

Regulatory affairs

FDA regulations

OPDP/APLB liaison

Promotional review

Leadership

Team mentoring

Cross-functional collaboration

Regulatory strategy

Risk assessment

Communication skills

Description du poste

Contract Length: 6-12-month contract with potential for conversion

Hours: 40/hrs

Start Date: ASAP, by EOY

Job Description:

The Director, US Advertising and Promotional Compliance, will serve as the therapeutic area lead and the Regulatory Affairs (RA) representative for assigned products. They will be responsible for reviewing and approving the regulatory content of materials created for product promotion, disease awareness and public affairs communications. The Director will also engage business partners for strategic planning on issues pertaining to product promotion and will participate in developing processes and procedures relevant to the creation, review and approval of promotional material. The Director will also act as the primary liaison with FDA on ad/promo regulatory issues concerning promotional materials.

Accountabilities:

• Reviewing US promotional, non-promotional, and scientific material, attending review meetings and providing regulatory guidance to the cross-functional team responsible for ensuring adherence to compliance standards and FDA regulations pertaining to prescription drug advertising, promotion, and communication as applicable
• Serving as primary contact for communications with the Office of Prescription Drug Promotion (OPDP) and/or Advertising and Promotional Labeling Branch (APLB) for assigned products
• Developing processes and procedures relevant to the creation, review and approval of advertising and promotional materials: Developing best practices, working instructions and/or SOPs to establish standards and consistency across company brands
• As needed, providing training support within client on requirements for prescription drug promotion including, but not limited to, sales training and compliance training in preparation for scientific congresses and conferences
• Advising product development teams on advertising and promotion issues to facilitate the strategic development of new products
• Maintaining regulatory expertise in product promotion and compliance by keeping current with issued FDA enforcement actions and through attendance of relevant conferences and/or seminars. Communicate new regulatory standards pertaining to prescription drug promotion to brand teams and management, as appropriate
• Participating in and supporting ongoing key initiatives including the development, implementation, and continued improvement of promotional review process
• Supporting and mentoring ad/promo colleagues
• 7+ years pharmaceutical industry in regulatory advertising and promotion
• Expertise in US advertising and promotional regulations and the current regulatory environment
• Experience communicating and negotiating directly with OPDP and/or APLB
• Experience leading a team or experience having direct reports
• Experience with global standards for advertising and promotional compliance
• Excellent written and verbal skills and strong interpersonal skills
• Consistent 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!