Associate Director, Regulatory Affairs, Advertising and Promotion

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) a liver disease with high unmet medical need. Madrigals medication Rezdiffra (resmetirom) is a once-daily oral liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).

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 Companys 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 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).

Also open to remote candidates

Madrigals Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance we empower employees to think like owners giving them a stake in the organization.

All employees receive equity which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidates qualifications skills education experience business needs and market demands. The base salary range for this position is $170000 - $207600 per year.

All full-time employees receive equity which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance we empower employees to think like owners giving them a stake in the organization.

Full-time employees are also eligible for comprehensive benefits including flexible paid time off medical dental vision and life / disability insurance and 401(k) offerings (i.e. traditional Roth and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance legal services and other addition we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal state and local laws.

We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance please contact

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.

Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site.

Please be aware that we have received 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 Madrigals 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.

Please also note that any correspondence with regard to employment would come from an authorized 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 or on behalf of Madrigal we recommend that you : do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to .

Required Experience :

Director

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1

Yearly Salary Salary : 170000 - 207600