Merz Therapeutics
Senior Manager - Regulatory Affairs, Advertising and Promotions
Merz Therapeutics, Raleigh, North Carolina, United States, 27601
Do you have strong regulatory experience in advertising and promotion with drugs, combo and biologics?
We are seeking a talented Ad/Prom Regulatory Senior Manager to be our go to regulatory person for all US and Canada scientific and promotional materials
Step into the future with us at Merz Therapeutics, where our family roots meet a bold new vision. Together, we're embarking on a transformative journey, blending time-honored traditions with exciting new products.
As a private, family-owned company, we have the liberty and support to make decisions for ourselves, our customers and the patients we serve. We pride ourselves on building an inclusive culture where there is room to celebrate individual growth with the ability to contribute to a common good as a collaborative team. Our mission is grounded in a long-term view of making a difference for the common good, while growing together as a family.
If you're looking to immerse yourself in a passionate team rooted in community, connection and camaraderie, then we're looking for YOU! #IAmMerz
This position provides strategic input on regulatory policy and standards and requirements in the development and implementation of marketing strategy and promotional programs for the US and Canada. Works collaboratively 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 reviewer for multiple product lines (drugs, drug/device combination, and biologics).
Essential Duties and Responsibilities:
Review Advertising/Promotional Materials:Review and approve proposed advertising and promotional materials for multiple product linesSubmit approved materials, when required, to appropriate health authorityComplete any pre-market submissions of materials requiring advisory comment in USMaintain current awareness of evolving FDA and Health Canada regulations and interpretations, FDA advisory letters, enforcement letters and policy issues affecting the pharmaceutical industry.Ensures that changes in Prescribing Information are reflected in promotional and advertising materials.Prepare and update Important Safety Information for products as needed with new labeling changes as well as variances needed for use in different media.Coordinate and implement training of Merz employees on regulatory issues pertaining to promotion of company products.Regularly monitor the regulatory compliance trends in the industry, interpret new regulations, guidance documents and enforcement actions.Act as liaison between regulatory and marketing teams for strategy for marketing approved products.Review Scientific Materials
Review and approve proposed scientific materials used by the medical affairs team for scientific education, training, and publication on multiple product lines.Participate in advisory boards, providing comment and synthesis on learnings back to the rest of the regulatory team.Act as liaison between regulatory and medical affairs team for strategy for education on approved productsJob Related qualifications/skills:
Education:
BA, BS, or advanced degree with an emphasis in science, health, or related field preferredProfessional Experience required:
3-5 years of experience in review of advertising and promotional materials for a marketed pharmaceutical product line.1-3 years of experience in review of scientific materials for a marketed pharmaceutical product line.Knowledge/skills required:
Strong understanding of business goals and marketing concepts and toolsStrong understanding of FDA and Health Canada drug and biologic advertising and promotional regulations.Proficiency with typical PC based applications (Microsoft Word, Adobe Acrobat, etc)Personal skills required:
Must perform independently with effective negotiation and strong decision making skillsMust possess strong interpersonal communication skills with ability for strategic and analytic thinkingMust have analytical and problem-solving skills associated with complex problemsMust be able to work effectively in a fast-paced multi-disciplinary environment
Don't meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Merz Therapeutics we are dedicated to building a diverse, inclusive, and authentic workplace, so if you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles.
Recruitment Note:
Merz Therapeutics only sends emails from verified "merz.com" addresses and never asks for sensitive, personal information or money. If you have any doubts about the authenticity of any type of communication from, or on behalf of Merz Therapeutics, please contact Therapeutics.HR@merz.com
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)
We are seeking a talented Ad/Prom Regulatory Senior Manager to be our go to regulatory person for all US and Canada scientific and promotional materials
Step into the future with us at Merz Therapeutics, where our family roots meet a bold new vision. Together, we're embarking on a transformative journey, blending time-honored traditions with exciting new products.
As a private, family-owned company, we have the liberty and support to make decisions for ourselves, our customers and the patients we serve. We pride ourselves on building an inclusive culture where there is room to celebrate individual growth with the ability to contribute to a common good as a collaborative team. Our mission is grounded in a long-term view of making a difference for the common good, while growing together as a family.
If you're looking to immerse yourself in a passionate team rooted in community, connection and camaraderie, then we're looking for YOU! #IAmMerz
This position provides strategic input on regulatory policy and standards and requirements in the development and implementation of marketing strategy and promotional programs for the US and Canada. Works collaboratively 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 reviewer for multiple product lines (drugs, drug/device combination, and biologics).
Essential Duties and Responsibilities:
Review Advertising/Promotional Materials:Review and approve proposed advertising and promotional materials for multiple product linesSubmit approved materials, when required, to appropriate health authorityComplete any pre-market submissions of materials requiring advisory comment in USMaintain current awareness of evolving FDA and Health Canada regulations and interpretations, FDA advisory letters, enforcement letters and policy issues affecting the pharmaceutical industry.Ensures that changes in Prescribing Information are reflected in promotional and advertising materials.Prepare and update Important Safety Information for products as needed with new labeling changes as well as variances needed for use in different media.Coordinate and implement training of Merz employees on regulatory issues pertaining to promotion of company products.Regularly monitor the regulatory compliance trends in the industry, interpret new regulations, guidance documents and enforcement actions.Act as liaison between regulatory and marketing teams for strategy for marketing approved products.Review Scientific Materials
Review and approve proposed scientific materials used by the medical affairs team for scientific education, training, and publication on multiple product lines.Participate in advisory boards, providing comment and synthesis on learnings back to the rest of the regulatory team.Act as liaison between regulatory and medical affairs team for strategy for education on approved productsJob Related qualifications/skills:
Education:
BA, BS, or advanced degree with an emphasis in science, health, or related field preferredProfessional Experience required:
3-5 years of experience in review of advertising and promotional materials for a marketed pharmaceutical product line.1-3 years of experience in review of scientific materials for a marketed pharmaceutical product line.Knowledge/skills required:
Strong understanding of business goals and marketing concepts and toolsStrong understanding of FDA and Health Canada drug and biologic advertising and promotional regulations.Proficiency with typical PC based applications (Microsoft Word, Adobe Acrobat, etc)Personal skills required:
Must perform independently with effective negotiation and strong decision making skillsMust possess strong interpersonal communication skills with ability for strategic and analytic thinkingMust have analytical and problem-solving skills associated with complex problemsMust be able to work effectively in a fast-paced multi-disciplinary environment
Don't meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Merz Therapeutics we are dedicated to building a diverse, inclusive, and authentic workplace, so if you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles.
Recruitment Note:
Merz Therapeutics only sends emails from verified "merz.com" addresses and never asks for sensitive, personal information or money. If you have any doubts about the authenticity of any type of communication from, or on behalf of Merz Therapeutics, please contact Therapeutics.HR@merz.com
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)