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Advertising and Promotions Manager

.pre {white-space: pre-wrap;} Your tasks and responsibilities

 

The primary responsibilities of this role, (Advertising & Promotions Manager), are to: 

 

  • Provide strategic regulatory advice on advertising and promotion materials and activities for assigned products in accordance with business goals and objectives, Food & Drug Administration regulations/guidances, Pharmaceutical Research and Manufacturers of America guidelines and company policy;

  • Serve as a primary regulatory advertising and promotion reviewer for assigned products on Legal/Medical/ /Regulatory (“LMR”) teams. Liaison with Office of Prescription Drug Promotion regarding advertising and promotion for assigned products;

  • Establish strong and positive working relationship with Office of Prescription Drug Promotion reviewers. With significant supervision from manager, drafts response to Office of Prescription Drug Promotion queries on assigned products for manager review and approval;

  • Act as active participant on Brand Teams, apply regulatory and therapeutic area knowledge to Brand Team’s objectives and initiatives to develop solutions with manager's input and approval to complex US promotional issues. For less complex issues, apply standard practice as trained and keep manager informed;

  • Ensure regulatory compliance while effectively managing business risks;

  • Consult with the Director, Advertising & Promotions on an ongoing basis;

  • Maintain awareness of competitor activities by monitoring major US medical meetings where assigned therapeutic area products are promoted;

  • Additionally, provide training to Bayer representatives responsible for exhibit booth activities at these meetings;

  • Monitor US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by Office of Prescription Drug Promotion, and by attendance of major Food & Drug Law Institute, Drug Information Association and other industry/Food & Drug Administration meetings;

  • Receive guidance and direction from manager to provide recommendations to Medical Affairs Teams on phase IV clinical trial design with regard to promotability of potential data/claims;

  • Receive guidance and direction from manager in order to work effectively with US Regulatory Manager on International Product Team to insure that regulatory strategy will result in commercially viable US labeling upon which future promotion and advertising will be based;

  • Participate in US labeling negotiations and Food & Drug Administration meetings as necessary;

  • Ensure that changes changes in US Prescribing Information are reflected in current promotions and advertising.

 

.pre {white-space: pre-wrap;} Who you are

 

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 (Ph.D., M.D., D.V.M. or Pharm.D. in life sciences.), or Master's degree with two (2) years of experience in biomedical research activities, or Bachelor's Degree with four (4)  years of experience in biomedical activities;
  • Experience in regulatory affairs preferred;
  • Familiarity with FDA regulations for the review of professional and consumer Rx drug advertising and promotion;
  • Proven ability to analyze and interpret efficacy and safety data;
  • Experience in leading activities necessary for promotional Office of Prescription Drug Promotion submissions (including pre-clearance and 2253, “time of first use” submissions);
  • Strong understanding of business goals of the involved business franchise, marketing concepts and tools;
  • Strong negotiation and decision making skills;
  • Must 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, and be able to provide creative solutions to complex problems.

 

.pre {white-space: pre-wrap;} Your application Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.