Job Description Associate Director, Office of Promotion and Advertising Review
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. Provides promotional regulatory strategy and prepares submissions for advisory comments by FDA and negotiates directly with FDA any changes requested. Provides regulatory, policy and standards consultation in the development and implementation of US marketing strategy and promotional programs. Works collaboratively with the business to ensure that promotional practices are consistent with regulatory guidelines and support business objectives. Proposes creative solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk. Functions as our Company's point of contact in written and verbal communications with FDA on issues related to advertising and promotional materials.
As a member of the Promotion Review Team, reviews and approves US promotional materials for compliance with the letter and spirit of FDA regulations and our Company's policies and standards. Review and approve promotional materials for submission to FDA in a timely manner and in accordance with FDA regulations.
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.
Maintain a productive relationship with FDA to help ensure successful and timely review of advisory submissions and effective resolution of regulatory actions. 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.
Provide input on clinical trial protocol design as it relates to the use of study results in U.S. promotion. Participate in the development of U.S. labeling to ensure support for anticipated promotional messages and claims. As the liaison with FDA participate in FDA labeling negotiation meetings and End of Phase II meeting discussions related to promotion.
Minimum Requirement: B.A. or B.S.
Required Experience and Skills:
Minimum 7 years' experience in pharmaceutical/biologics regulatory, legal, scientific, medical, or marketing disciplines
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
Strong interpersonal skills with ability to demonstrate strategic and analytic thinking
Demonstrate an ability to negotiate and influence others effectively
Preferred Experience and Skills:
Experience reviewing and approving pharmaceutical/biologics promotion; BA, BS or advanced degree with an emphasis in science, health care or related fields
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" and that great medicines can make a significant impact to our world. And 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.
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as "Merck" in the United States, Canada & Puerto Rico. We are known as "MSD" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.
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. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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.
If you have been offered a separation benefits package but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.
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