Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
Primary responsibilities include:
Responsible for the review and approval of all US promotional materials and submission of such materials to the Food Drug Administration (FDA) at the 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.
Minimum Education 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 the 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” 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. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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.
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We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Search Firm Representatives Please Read Carefully Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status: Regular Relocation: Domestic Travel Requirements: 10% Flexible Work Arrangements: Remote Work Number of Openings: 5 Requisition ID: R91466
Internal Number: R91466
About Merck & Co., Inc.
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.