What are the responsibilities and job description for the Associate Director, Regulatory Affairs, Advertising and Promotion position at Madrigal Pharmaceuticals?
ABOUT MADRIGAL: Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.
The Associate Director, Regulatory Affairs, Advertising and Promotion is responsible for providing commercial regulatory strategy and direction to enable the business to meet its commercial needs in support of patients and in a compliant manner.
Key Responsibilities
Reviewing and approving the regulatory content of materials created for product promotion, corporate, and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices.
Represent the commercial regulatory perspective at the promotional review committee (PRC) which includes cross functional partners from Marketing, Medical Affairs, and Legal/Compliance
Lead discussions in review committees, collaborating with stakeholders from Legal, Medical, and commercial teams to reach consensus on promotional materials.
Serve as internal expert on FDA regulations, guidance and enforcement trends governing the promotion of Madrigal products.
Assumes a leadership role in updating and advising Company stakeholders on changes in regulations, policies, and enforcement which may impact the Company’s promotional activities.
Manage interaction with the Office of Prescription Drug Promotion OPDP including response to regulatory inquiries, preparation of submissions for advisory comments, and timely preparation and submission of promotional materials under cover of FDA Form 2253.
Ensuring stakeholder awareness on planned and approved label updates and how they impact Promotional and Medical materials. Provide key stakeholders with guidance on implementation of ISI, and labels in a timely manner.
Align and maintain effective communication channels with Medical, Marketing, Regulatory, Legal, and corporate counterparts.
Provide training on FDA regulations for advertising and promotion to employees and agents of Madrigal.
Participate in company working groups on advertising and promotion standards and guidelines.
Assist on the development strategies of US labeling to ensure support for anticipated promotional messages and claims.
Desired Experience/Education And Personal Attributes
Requires a BA/BS degree in a scientific discipline and advanced scientific degree preferred.
Minimum 7 years of Pharmaceutical/Biotech industry experience in drug advertising and promotion review and 4 years’ experience as the primary Regulatory representative in the review of prescription drug advertising and promotion for compliance with applicable FDA laws, regulations, and guidance documents, including direct experience communicating with OPDP. significant Subpart H and/or Subpart E submission experience
Excellent verbal, written communication skills.
Strong attention to detail with the ability to check documents for accuracy as well as consistency.
Proficiency using promotional review software, such as Veeva Promomats.
Position reports to Senior Director, US Advertising and Promotion. In the absence of the Senior Director, the position is responsible for day-to-day operations.
Ability to navigate complex regulatory framework while remaining solutions-oriented to address corporate objectives.
Knowledge of clinical study design and statistical analyses in the assessment of promotional claims.
Must be capable of developing and implementing commercial regulatory strategy and managing complex negotiations with internal and external stakeholders.
Consistently meets deadlines without compromise to work.
Ability to distill complexity into understandable and actionable language.
Willingness to travel to various meetings or sites, including overnight trips.
Location Conshohocken, PA or Waltham, MA (must adhere to hybrid working schedule of being onsite three times per week).
Compensation: Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.
Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.
Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.
The Associate Director, Regulatory Affairs, Advertising and Promotion is responsible for providing commercial regulatory strategy and direction to enable the business to meet its commercial needs in support of patients and in a compliant manner.
Key Responsibilities
Reviewing and approving the regulatory content of materials created for product promotion, corporate, and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices.
Represent the commercial regulatory perspective at the promotional review committee (PRC) which includes cross functional partners from Marketing, Medical Affairs, and Legal/Compliance
Lead discussions in review committees, collaborating with stakeholders from Legal, Medical, and commercial teams to reach consensus on promotional materials.
Serve as internal expert on FDA regulations, guidance and enforcement trends governing the promotion of Madrigal products.
Assumes a leadership role in updating and advising Company stakeholders on changes in regulations, policies, and enforcement which may impact the Company’s promotional activities.
Manage interaction with the Office of Prescription Drug Promotion OPDP including response to regulatory inquiries, preparation of submissions for advisory comments, and timely preparation and submission of promotional materials under cover of FDA Form 2253.
Ensuring stakeholder awareness on planned and approved label updates and how they impact Promotional and Medical materials. Provide key stakeholders with guidance on implementation of ISI, and labels in a timely manner.
Align and maintain effective communication channels with Medical, Marketing, Regulatory, Legal, and corporate counterparts.
Provide training on FDA regulations for advertising and promotion to employees and agents of Madrigal.
Participate in company working groups on advertising and promotion standards and guidelines.
Assist on the development strategies of US labeling to ensure support for anticipated promotional messages and claims.
Desired Experience/Education And Personal Attributes
Requires a BA/BS degree in a scientific discipline and advanced scientific degree preferred.
Minimum 7 years of Pharmaceutical/Biotech industry experience in drug advertising and promotion review and 4 years’ experience as the primary Regulatory representative in the review of prescription drug advertising and promotion for compliance with applicable FDA laws, regulations, and guidance documents, including direct experience communicating with OPDP. significant Subpart H and/or Subpart E submission experience
Excellent verbal, written communication skills.
Strong attention to detail with the ability to check documents for accuracy as well as consistency.
Proficiency using promotional review software, such as Veeva Promomats.
Position reports to Senior Director, US Advertising and Promotion. In the absence of the Senior Director, the position is responsible for day-to-day operations.
Ability to navigate complex regulatory framework while remaining solutions-oriented to address corporate objectives.
Knowledge of clinical study design and statistical analyses in the assessment of promotional claims.
Must be capable of developing and implementing commercial regulatory strategy and managing complex negotiations with internal and external stakeholders.
Consistently meets deadlines without compromise to work.
Ability to distill complexity into understandable and actionable language.
Willingness to travel to various meetings or sites, including overnight trips.
Location Conshohocken, PA or Waltham, MA (must adhere to hybrid working schedule of being onsite three times per week).
Compensation: Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.
Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.
Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.
