Job Description Organon is a Women's Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women's health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people. We're looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress. At Organon, you'll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets. It's going to be an exciting future—come be a part of it! Primary Responsibilities: Responsible for the review and approval of all US promotional materials for assigned brands (pharmaceutical or medical device). Provides promotional regulatory strategy and prepares submissions for advisory feedback 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 Organon 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 policies and standards. Review and approve promotional materials for submission to FDA in a timely manner and in accordance with FDA regulations. Work with cross functional teams on pipeline development plans for prioritized opportunities. Responsible for the review and approval of all US promotional materials for assigned brands (pharmaceutical or medical device). Provides promotional regulatory strategy and prepares submissions for advisory feedback 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 Organon point of contact in written and verbal communications with FDA on issues related to advertising and promotional materials. Support the US commercial organization 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. Oversees 2253 operations. Education Minimum Requirements: Bachelors of Art or Bachelor of Science or advanced degree with an emphasis in science, health care or related fields. Required Experience and Skills: Minimum 5 years' experience in pharmaceutical/biologics regulatory, legal, scientific, medical, or marketing disciplines. Broad understanding of the process of pharmaceutical/medical device 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. Experience reviewing and approving pharmaceutical/biologics/medical device promotion. Preferred Experience and Skills: Direct experience with FDA regulations relating to advertising and promotion for prescription products/medical devices, 2253 operations AND / OR product development process, including labeling development process. Who We Are: Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman. Subject to applicable law, all prospective US Organon hires will be required to demonstrate that they have been fully vaccinated against COVID-19 with a vaccine authorized or approved by the Food and Drug Administration (FDA), or qualify for a medical or religious accommodation to this vaccination requirement, as a precondition of employment. Residents of Colorado: to request this role's pay range: email: [Click Here to Email Your Resumé] Jersey City and New York City Positions: to request this role's pay range and benefits, email: [Click Here to Email Your Resumé] US and PR Residents Only If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at [Click Here to Email Your Resumé]. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement OFCCP Pay Transparency Rule Organon is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations. Search Firm Representatives Please Read Carefully Organon LLC., 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:No relocation VISA Sponsorship: Travel Requirements:10% Flexible Work Arrangements:Remote Work Shift: Valid Driving License:No Hazardous Material(s): Number of Openings:1 Requisition ID:R510606 This employer is a corporate member of myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals, students, inclusive employers & anyone who believes in workplace equality.