at Merck in Dover, Delaware, United States
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
Residents of Colorado
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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 .
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Dover, Delaware 19904