Associate Director, Office of Promotion & Advertising Review
Location: North Wales (Upper Gwynedd), Pennsylvania
Type: Full Time
Preferred Education: 4 Year Degree
4 openings available.
Internal Number: R142981
Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.
Reports to Director/Senior Director OPAR
The Associate Director is responsible for the review and approval of all US promotional materials and submission of such materials to FDA at time of dissemination for assigned brands.
As a member of the Promotion Review Team (PRT), works collaboratively with the Legal and Medical review team, Compliance, and Commercial colleagues to ensure that promotional practices are consistent with regulatory guidelines, company policies, and support business objectives.
Proposes creative regulatory strategy and solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk.
Prepares submissions for advisory comments by FDA and negotiates directly with FDA any changes requested.
Functions as our company's point of contact in written and verbal communications with FDA on issues related to advertising and promotional materials. Maintain a productive relationship with FDA to help ensure successful and timely review of advisory submissions and effective resolution of regulatory actions.
Provides regulatory, policy and standards consultation in the development and implementation of US marketing strategy and promotional programs.
Support the US business 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 assure promotional materials satisfy U.S. promotional regulations, corporate standards and policies and business objectives.
Develop and implement effective strategies for FDA promotional submissions. Prepare submissions of press releases and promotional materials for FDA review and comment. Manage the development of correspondence with FDA and the interpretation of FDA advisory comments.
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.
B.A. or B.S.
Minimum 5 years’ experience in pharmaceutical/biologics industry supporting the promotional review process.
Direct experience with FDA regulations relating to advertising and promotion for prescription products and/or product development process, including labeling development process.
Broad understanding of the process of pharmaceutical promotional development and review 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 analytic thinking.
Demonstrate an ability to negotiate and influence others effectively.
Action oriented with strong cross-functional collaboration skills.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization.
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Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.