Regulatory Affairs Advertising & Promotions Senior Manager - Merz North America, Inc

Provides strategic input on regulatory policy and standards and requirements in the development and implementation of marketing strategy and promotional programs. Leads collaborative discussion with the commercial organization to ensure that promotional and advertising practices are consistent with regulatory requirements and guidelines while supporting business objectives. Proposes creative solutions to challenging promotional concepts that meet business objectives and minimizes regulatory risk. Serves as a primary regulatory advertising and promotion (PRC) and Medical Affairs material (SRC) reviewer for multiple product lines (pharmaceuticals and medical devices) in the United States and Canada.

 This position works with minimal supervision and requires a high degree of interaction with Merz employees at all levels within the organization and may interact with governmental agencies. Consults with the Senior Director, Regulatory Affairs, Advertising and Promotion as necessary.

Responsibilities

• US & Canada Ad/Prom review:

  • Manages US and Canada commercial activities from a regulatory advertising and promotion perspective 

• Regulatory advice and guidance on commercial and scientific materials:

  • Provide timely regulatory advice and guidance to US and Canadian Commercial team leads and Medical Affairs with respect to promotional (PRC) and Medical Affairs (SRC) materials 

• Development of messaging with creative compliant recommendations:

  • Creatively advise on the development of product messages and materials across multiple functional areas successful campaigns and new product/indication launches

• OPDP submissions:

  • Responsible for all FDA OPDP submissions on form 2253 which may include submissions for advisory comment 

• Training of contracted speakers on behalf of the company:

  • Leads regulatory training of HCP speakers, and key product endorsers, which may include celebrities. Maintain and relay to commercial counterparts evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policy issues affecting the pharmaceutical and medical device industries

• Ensuring consistency in materials with currently approved labeling:

  • Ensures that changes in Prescribing Information are reflected in promotional and advertising materials

• Updating Important Safety Information consistent with labeling changes:

  • Prepare and update Important Safety Information for products as needed with new labeling changes as well as variances needed for use in different media

• Training of Merz Employees on compliant promotion:

  • Coordinate and implement training of Merz employees on regulatory issues pertaining to promotion of company products

• Provide occasional on-demand reviews for pivotal commercial events:

  • Periodically required to work after normal working hours for on-demand promotional material approvals for pivotal commercial initiatives

Technical & Functional Skills:

• MS Office

Minimum Qualifications:

• BA, BS or advanced degree with an emphasis in science, health care or related fields.
• 5 years of experience in the regulatory field with at least 2 years of experience in review and approval of professional and consumer prescription pharmaceutical advertising and promotion
• Experience in leading activities for promotional OPDP submissions (including Form 2253 submissions)

Preferred Qualifications:

• Experience in both medical device and pharmaceutical advertising and promotion is desirable.
• Experience with regulatory activities involved with a product launch. 
• Experience with Veeva Promomats                                                                                         

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Regulatory Affairs and Compliance