Associate Director, Office of Promotion and Advertising Review-REG002683
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
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 Merck 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 Merck 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.
- B.A. or B.S.
- 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
- Experience reviewing and approving pharmaceutical/biologics promotion; BA, BS or advanced degree with an emphasis in science, health care or related fields
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Job: Regulatory Affairs Generic
Job Title:Assoc. Dir, Regulatory Affairs
Primary Location: NA-US-PA-Upper Gwynedd
Employee Status: Regular
Number of Openings: 1
Shift (if applicable): N/A
Company Trade Name:Merck