Director, Regulatory Affairs, Promotion and Advertising Review (OPAR)

Merck; North Wales (Montgomery County); Hybrid; USD 173.000 - 273.000; Vollzeit

Zusammenfassung

Merck in North Wales, PA seeks an Individual Contributor Director to lead the review and approval of U.S. promotional materials, ensuring compliance with FDA regulations and company policies.

You will collaborate with legal, medical, and commercial teams to align messaging with regulatory requirements and business goals. You will serve as the regulatory expert for promotions, manage FDA interactions, and mentor staff while shaping global and local strategies from development through launch.

Qualifikationen

• Minimum of ten years in pharma/biologics with regulatory focus.
• At least five years as primary reviewer of advertising materials.
• Deep understanding of FDA regulations and company policies.

Aufgaben

• Lead the review and approval of US promotional materials with regulatory oversight.
• Liaise with FDA divisions and manage submissions for advisory comment.
• Develop regulatory strategies to meet business objectives while minimizing risk.
• Lead regulatory training and mentor team members.

Kenntnisse

Regulatory experience

FDA regulations

Strategic thinking

Negotiation

Cross-functional collaboration

Pharmaceutical advertising

PhRMA Code

Policy implementation

Problem solving

Regulatory affairs

Team collaboration

Advertising compliance

Ausbildung

Bachelor's degree in science/health care or related fields

Master’s/PhD/PharmD preferred

Jobbeschreibung

Job Description

The Individual Contributor Director is responsible for the review and approval of US promotional materials and serving as the promotional regulatory expert with legal, medical and commercial colleagues to ensure that promotional practices are consistent with regulatory guidelines, our Company's policies, and support business objectives. Functions at an advanced and independent level.

Serve as the liaison and manage correspondence with FDA’s promotional review divisions OPDP/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.

Proactively partners with the review team, compliance, and commercial colleagues to ensure a cohesive and integrated regulatory strategy from early development through approval and marketing.

Lead the development of assigned products’ promotional regulatory strategy, including the rationale for Global Target Product Information (GTPI). Provide solutions to complex regulatory scenarios and content.

Identify and provide solutions during 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 an expert understanding of FDA regulations governing advertising and promotion. Proactively provides solutions to complex regulatory and commercial needs in a compliant manner, consistent with US FDAregulations, PhRMA Code and Principles, and company policy and procedures.

Is seen as a leader and is sought out by peers. Creates capacity to provide support to team members. Proactively seeks opportunities to take on more complex projects and provide promotional regulatory training and coaching to team members. Mentors’ new hires.

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

Qualifications, Skills & Experience

Education

Minimum Requirement: B.A. or B.S. degree with an emphasis in science, health care or related fields.

Preferred: Master’s, PhD or PharmD degree with an emphasis in science, health care or related fields.

Qualifications

• Minimum of ten years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory or scientific disciplines, including a minimum of five years of direct experience as the primary reviewer of advertising and promotional materials.
• Demonstrated in-depth understanding of FDA regulations and our Company's policies and procedures related to promotion development and implementation, as well as promotion review processes.
• Demonstrated strong diplomacy, interpersonal, and negotiation skills. Recognized as a consensus builder with strong strategic and analytical thinking capabilities.
• Proven track record of effective collaboration with external stakeholders, including FDA branches (OPDP, APLB), alliance relationships with peer companies, and external consortia and trade organizations such as DIA.
• In-depth understanding of the clinical development process, regulatory policy, labeling development, and FDA approval processes.
• Demonstrated ability to identify solutions to complex promotional regulatory issues.
• Demonstrated superior verbal and written communication skills.

Required Skills

Advertising Compliance, Communication, Cross-Functional Teamwork, Detail-Oriented, FDA Regulations, Negotiation, Pharmaceutical Advertising, PhRMA Code, Policy Implementation, Problem Solving, Regulatory Affairs, Regulatory Risk, Regulatory Strategies, Strategic Thinking, Team Collaboration

Requirements

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The primary location for this posting is:

USA - Pennsylvania - North Wales (Upper Gwynedd)

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$173,200.00 - $272,600.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

Yes

Hazardous Material(s)

n/a