Merck is hiring: Associate Director, Advertising & Promotion Regulatory Affairs

Job Description

Reports to the Director / Senior Director in the Office of Promotion and Advertising Review (OPAR).

The Associate Director is responsible for the review and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices are consistent with regulatory guidelines, our company's policies, and support business objectives.

Serve as the liaison and manage correspondence with FDA’s promotional review divisions Office of Promotion and Advertising Review (OPDP) / Advertising and promotional labeling branch (APLB), including complex regulatory questions and submissions for advisory comment.

Propose creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk.

Provide regulatory consultation in the development and implementation of US marketing strategy and promotional programs.

Support the US commercial teams, including relevant stakeholders, by participating in strategy discussions and extended team meetings and providing regulatory guidance and perspective on marketing strategies and promotion objectives and tactics. Provide promotional regulatory input on concepts and draft materials to help ensure promotional materials are aligned with U.S. promotional regulations, corporate standards and policies, and business objectives.

Actively participate in labeling and global regulatory team meetings to ensure support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of study results in U.S. promotion.

Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters, and policy issues affecting the pharmaceutical / biologics industry. Communicate significant changes in FDA perspective to relevant stakeholders.

Serve as a mentor within the department. Ability to take on more complex projects and provide promotional regulatory training and coaching to team members.

Contribute to the development of departmental strategic initiatives to drive effective, compliant promotional regulatory review.

Required Experience and Skills :

• Minimum of five years of pharmaceutical / biologics industry or related experience with an emphasis in regulatory or scientific disciplines, including a minimum of two years of direct experience as the primary reviewer of advertising and promotional materials.
• Demonstrated knowledge of FDA regulations relating to advertising and promotion for prescription products.
• Proactive with strong cross-functional collaboration skills.
• Demonstrated history of successful interactions with the promotional review divisions of FDA (OPDP / APLB) or experience developing / leading the regulatory strategy for a product filing / launch.
• Understanding of the product development and labeling process.
• Excellent verbal and written communication skills.
• Attention to detail and ability to manage multiple priorities simultaneously.
• Strong interpersonal skills with ability to demonstrate strategic and analytical thinking.
• Demonstrated ability to negotiate and influence others effectively.

Minimum education required :

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

US and Puerto Rico Residents Only :

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.

Employee Status : Regular

Relocation : No relocation

VISA Sponsorship : No

Travel Requirements : 10%

Flexible Work Arrangements : Hybrid

Shift : Not Indicated

Valid Driving License : No

Hazardous Material(s) : NA

Job Posting End Date : 02 / 25 / 2025

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