Regulatory Advertising and Promotion Policy Director (Digital)

Basic qualifications:

  • Degree in a biological or health care scientific discipline
  • 5 -7 years of experience in pharmaceutical/biologics regulatory, or scientific disciplines
  • 2-3 years in the review of prescription drug advertising and promotion for compliance with applicable FDA laws, regulations and guidance documents
  • Demonstrated experience in the review multi-channel digital promotion and related requirements to comply with FDA laws and regulations
  • Demonstrated history of successful interactions with OPDP reviewers

Preferred qualifications:

  • Advanced degree in biological or health care scientific discipline (or MD)
  • 7+ years of experience in pharmaceutical/biologics regulatory, or scientific disciplines
  • 3+ years in the review of prescription drug advertising and promotion for compliance with applicable FDA laws, regulations and guidance documents
  • Demonstrated history of successful interactions with OPDP reviewers for multiple products, across a range of therapeutic areas.
  • Demonstrated understanding of the drug development process

Details:

GSK are a science-led global healthcare company. We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.

We are committed to widening access to our products so more people can benefit, no matter where they live in the world or what they can afford to pay.

In 2016 we produced more than two billion packs of medicine, delivered 833 million doses of vaccines and produced five billion packs of consumer healthcare products. Through our 89 manufacturing sites, we serve customers in 190 countries.

We know that we can't take on the world's healthcare challenges alone, which is why we collaborate with over 3,000 scientific, academic and charitable partners – combining expertise to accelerate progress.

Purpose:

  • For assigned products, which include major assets, provide sound regulatory advice that minimizes the risk of regulatory and legal action, competitively positions assigned products and is consistent with applicable FDA regulations and GSK policies for advertising and promotion of prescription drug products and biologics.

Accountabilities:

  • Competitively positioned promotional materials that comply with applicable FDA and corporate regulations, policies and guidance.
  • Internal expert on FDA regulations governing the promotion of assigned products.
  • Provide regulatory insight, judgment, sound decision making to enable high speed, agile, digital delivery of programs and tactics for assigned products.
  • Actively collaborates as part of a multidisciplinary creative team to recommend appropriate solutions and /or actions for novel digital promotional tactics, sometimes with little or no precedent.
  • Act as a credible, influential, respected spokesperson for assigned products during interactions with the Office of Prescription Drug Promotion (OPDP) reviewers.
  • Establish and nurture a productive, transparent relationship with OPDP to achieve successful and timely review of advisory submissions and effective resolution of regulatory actions.
  • Manage interactions with OPDP including responses to regulatory inquiries or enforcement actions, preparation of complete, accurate, and high quality submissions for advisory comments, and discussion with OPDP staff on requested changes.
  • Leadership on digitally-focused copy approval teams such that recommendations are recognized as well-reasoned, valid and appropriate.
  • Analyze whether clinical and non-clinical promotional claims are supported.
  • Provide insight, judgment and sound decisions on promotional programs and tactics for assigned products.
  • Maintain a deep and current awareness of evolving FDA regulations and interpretations, FDA advisory comments, enforcement letters and policy issues affecting the pharmaceutical/biologics industry and communicate relevant information appropriately to stakeholders.
  • In-depth understanding of labeling for assigned GSK and competitor products and the subsequent translation of that knowledge into the development of promotional materials.
  • Ensure application of key learnings across assigned brands.
  • Help ensure alignment of development and commercial objectives.
  • With limited supervision, recommend appropriate actions for proposed advertising and promotion sometimes with little or no precedent.

Responsibilities:

  • Actively collaborates as part of a multidisciplinary creative team to recommend appropriate solutions and /or actions for novel digital promotional tactics, sometimes with little or no precedent
  • Provides strategic and operational leadership to Marketing Brand Teams, Legal, Medical Affairs in the development of advertising and promotion for the US market (for major company assets) in accordance with business goals and objectives, FDA regulation, ICH guidelines, PhRMA guidelines and company policy.
  • Requires strong verbal and written communication skills; strong interpersonal skills; good listening skills; flexible thinking; demonstrated ability to influence and collaborate with others; demonstrated customer focus and demonstrated ability to facilitate appropriate team decisions in fast paced environment based on Regulatory and Pharmaceutical experience.
  • Requires 100% dedicated alignment to provide promotional review support in a collaborative matrixed team for a high volume and agile, multi-channel digital promotion/marketing work stream.
  • Effective communications with reviewers within OPDP that expedite resolution of issues relating to assigned products.
  • Help ensure labeling that the successful commercialization of assigned GSK product.
  • In-depth understanding of issues involved with the development of product labeling for the relevant GSK asset(s) and a knowledge of labeling for key competitor products.
  • Ensure that changes in US prescribing information are reflected in current promotion and advertising.
  • Identify continuous improvement opportunities.
  • Participate in company, government and trade association working groups that focus on advertising and promotion standards and guidelines.
  • Ensure alignment of development and commercial objectives.

Competencies and Capabilities:

  • This position is expected to influence and persuade a cross-functional copy approval teams for assigned products on regulatory-related issues and independent solutions to address potential risk mitigation, as well as for all verbal and written communications with OPDP reviewers within FDA
  • This position must be able to evaluate and articulate regulatory risk to members of legal, regulatory, medical information, medical affairs, and the commercial organization at senior levels within GSK.
  • This position is expected to routinely influence and persuade others on difficult and complex issues that have the potential for significant reputational and financial impact on the organization.
  • This position is responsible for all verbal and written communications with OPDP reviewers within FDA for assigned products; and therefore, must possess strong verbal and written communication skills and be able to effectively communicate difficult and complex issues in a way that accurately and persuasively communicates the issues.
  • This position is responsible for authoring complaint letters concerning competitor products that are filed with OPDP.
  • This position must be able to persuasively argue GSK's position when it differs from FDA's position.

Role will work within a co-located matrix team with up to 50% travel primarily within state of NC.

  • LI-GSK

Contact information:

You may apply for this position online by selecting the Apply now button.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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