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Fda Opdp Jobs (NOW HIRING)

McKinney

Medical Editorial Supervisor

New York, NY · On-site

$90K - $115K/yr

Deep expertise in AMA style , with strong working knowledge of FDA/OPDP regulations for medical/pharma advertising. * Proven ability to manage multiple brands, deliverables, and style frameworks ...

BGBx

Group Copy Supervisor

New York, NY · On-site +1

$125K - $150K/yr

Familiarity with regulatory requirements (e.g., FDA, OPDP, medical/legal review processes). * Exceptional writing, editing, and communication skills. * Ability to multitask, manage multiple projects ...

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Fda Opdp information

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How much do fda opdp jobs pay per hour?

As of Jun 15, 2026, the average hourly pay for fda opdp in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.

What is the FDA OPDP?

The FDA OPDP stands for the Office of Prescription Drug Promotion within the U.S. Food and Drug Administration. This office is responsible for ensuring that prescription drug advertising and promotional labeling is truthful, balanced, and not misleading. OPDP reviews promotional materials from pharmaceutical companies, provides guidance on promotional practices, and enforces regulations to protect public health. They also educate industry and the public about the rules and expectations regarding drug promotion.

What are the key skills and qualifications needed to thrive as an FDA OPDP (Office of Prescription Drug Promotion) professional, and why are they important?

To thrive as an FDA OPDP professional, you need a strong background in regulatory affairs, pharmaceutical sciences, or health-related fields, often supported by relevant advanced degrees. Familiarity with FDA regulations, drug labeling requirements, and systems like DARRTS (Document Archiving, Reporting, and Regulatory Tracking System) is crucial. Exceptional analytical skills, attention to detail, and effective communication are important soft skills for evaluating promotional materials and collaborating with stakeholders. These skills ensure that prescription drug promotion complies with regulations, protecting public health and maintaining industry integrity.

What is the difference between Fda Opdp vs Fda Medical Officer?

AspectFda OpdpFda Medical Officer
Required CredentialsMedical degree, often with regulatory or industry experienceMedical degree, often with clinical or research background
Work EnvironmentRegulatory agency, reviewing medical device and drug applicationsRegulatory agency, evaluating clinical data and medical aspects of products
Employer & Industry UsageFDA, focusing on premarket review and complianceFDA, involved in medical review and policy development

Fda Opdp and Fda Medical Officer roles both require medical credentials and involve working within the FDA. However, Fda Opdp primarily focuses on premarket review of medical devices and drugs, while Fda Medical Officers often evaluate clinical data and provide medical expertise for regulatory decisions. Both roles are essential in ensuring product safety and efficacy but differ in their specific responsibilities and focus areas.

What are some common challenges faced by professionals working in the FDA's Office of Prescription Drug Promotion (OPDP)?

Professionals in the FDA's OPDP often face the challenge of keeping up with rapidly evolving pharmaceutical marketing strategies, including digital and social media campaigns. Balancing the need to protect public health while engaging with industry stakeholders requires careful analysis of promotional materials to ensure compliance with FDA regulations. The role also demands strong attention to detail, as even minor misrepresentations in drug advertising can have significant consequences. Collaboration with legal, medical, and regulatory experts is a regular part of the job to address complex cases effectively.
Infographic showing various Fda Opdp job openings in the United States as of June 2026, with employment types broken down into 25% As Needed, 50% Contract, and 25% Nights. Highlights an 65% Physical, 11% Hybrid, and 24% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Head of U.S. Regulatory Advertising & Promotion and Strategic Commercialization

Argenx

Remote

$268K - $368K/yr

Full-time

Medical, Retirement

Posted 13 days ago

Job description

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.
We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.
argenx is seeking a senior regulatory leader to define and execute U.S. regulatory strategy for promotional materials across the product lifecycle. This role serves as the primary regulatory authority for FDA advertising and promotion compliance and acts as a strategic business partner to Commercial, Medical Affairs, Legal, and Market Access to enable compliant, differentiated launch and in-market execution. The role contributes to broader commercialization strategy, including labeling, claims optimization, and lifecycle management.
Roles and Responsibilities:
  • Provide senior regulatory expertise in FDA advertising and promotion requirements, including OPDP guidance, enforcement trends, and industry best practices.
  • Lead regulatory oversight and approval for promotional and medical education materials (HCP, consumer, digital, omnichannel, speaker programs, and congress materials).
  • Drive a future focus through a digitally enabled, AI-forward regulatory capability, including evolving content creation, modular content, and review processes.
  • Serve as primary regulatory interface with FDA OPDP, including advisory comments, voluntary submissions, and responses to inquiries.
  • Interpret enforcement actions (Untitled Letters, Warning Letters) to inform internal standards.
  • Partner cross-functionally to enable compliant product differentiation and value communication.
  • Provide regulatory input into launch readiness, messaging frameworks, and lifecycle strategies.
  • Lead and scale U.S. Ad/Promo capabilities to support multiple launches across therapeutic areas.
  • Future-proof the MRC/MMRC process to align with automation, artificial intelligence, and modern go-to-market models.
  • Balance compliance and commercial objectives through risk-based decision making.
  • Contribute to shaping long-term Vision and growth strategy across multiple assets and indications.

Leadership & Governance:
  • Build, lead, and mentor a high-performing U.S. regulatory Ad/Promo team.
  • Establish governance frameworks and decision-making processes for promotional review.
  • Drive consistency in regulatory interpretation across brands and therapeutic areas.
  • Provide training and guidance to internal stakeholders.

Education, Qualifications and Experience:
  • 15+ years of regulatory experience with 5-7+ years in Ad/Promo roles.
  • Deep expertise in FDA Ad/Promo landscape.
  • Proven leadership in matrixed environments and experience supporting product launches.
  • Strong strategic mindset and executive communication skills.
  • Digitally savvy leader comfortable operating in AI-enabled environments.
  • Ability to innovate and evolve regulatory processes.

#LI-remote
For applicants in the United States: The annual base salary hiring range for this position is $268,000.00 - $368,500.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks.
This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.
At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.
Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates ("argenx") will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com.
If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response.

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