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61477292 Director Advertising Promotions - Whippany, NJ

Job Information

ID :
# of Positions :
Minimum Education Level :
Bachelor's Degree
Experience Required :
7+ years
Duration :
Full Time Regular
Shift :
Hours per week:

Job Description



The primary responsibilities of this role, Director Advertising Promotions, are to:

Manage regulatory aspects of Post-Marketing regulatory submissions and communications with the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) for assigned products;
Foster collaborative, efficient, and effective working relations with FDA in order to further build the cordial working relationship between Bayer and FDA;
Develop regulatory, strategic, and compliance plans for maximizing the commercial aspects for the marketing of assigned products;
Manage timelines to achieve stated goals;
Advise the Corporation on relevant new and existing regulatory risk and compliance requirements and provide regulatory expertise, advice, and support to Sales and Marketing and other product-related teams and the Legal Medical Regulatory team (LMR);
Foster and facilitate teamwork between RA and these allied functions;
Contribute to the development and implementation of Corporate and Department procedures and policies for regulation of marketed promotional materials;
Provide leadership for and manage regulatory aspects of the LMR review / approval process for product promotional materials, maintain compliance of promotional materials with the governing FDA regulations, and submit promotional materials to OPDP in a timely fashion;
Monitor and interpret promotional labeling regulations and guidelines for the successful and compliant commercial marketing of Bayer's pharmaceutical products;
Pro-actively monitor the latest regulations, guidance, and actions from the FDA and competitors that may influence the landscape;
Provide colleagues in RA and allied functions with cutting edge guidance on requirements and changes;
Provide recommendations to the RA strategists on Global Project Teams to ensure that regulatory strategy will result in commercially viable U.S. labeling upon which future promotion and advertising will be based (TPP);
Maintain awareness of competitor activities by monitoring major U.S. Medical meetings where assigned therapeutic area products are promoted;
Provide training to Bayer representatives responsible for exhibit booth activities at these meetings;
Prepare complaint letters to OPDP;
Monitor U.S. regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by OPDP, and by attendance of major FDLI, DIA and other industry/FDA meetings;
Participate in U.S. labeling negotiations and FDA meetings as necessary to support Advertising and Promotions activities;
Ensure that changes in U.S. Prescribing Information are reflected in current promotions and advertising;
Mentor Regulatory Advertising personnel.


Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

Advanced technical degree such as Ph.D., M.D., D.V.M. or Pharm.D. in life sciences with at least eight years of industry experience in medical research activities or Master of Science with at least 10 years of industry experience in medical research activities or Bachelor of Science with at least 14 years of industry experience in medical research activities;
At least five years of local regulatory experience or equivalent related experience in a highly drug-regulated country;
Experience in the review of drug advertising and promotion;
Proven ability to analyze and interpret efficacy and safety data;
Strong understanding of business goals of the involved business franchise, marketing concepts and tools;
Perform independently with strong negotiation and decision making skills;
Be able to work in a multi-disciplinary environment;
Possess strong interpersonal and communication skills;
Have analytical and problem-solving skills associated with problem reviews and inquiries;
Be able to provide creative solutions to complex problems.

Preferred Qualifications:

Excellent knowledge and understanding of U.S. regulations for drug promotion/advertising and U.S. labeling.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Company Information

Name :
Bayer US LLC
Description :
Passionate People Can Create Change
Our business success is largely attributable to the knowledge, skills and commitment of our employees. It is their ability to innovate and their willingness to embrace continuous development that drives our position as a world-class innovation company.

Sustained success is only possible if we create working conditions that allow all employees to utilize their talents optimally. This is why we value diverse perspectives and provide our employees with the ongoing training they need to remain at the top of their respective fields.
Type :
Direct Employer
Address :
100 Bayer Boulevard
Hanover, NJ 07981

Application Information

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