DIRECTOR, REGULATORY AFFAIRS FOR ADVERTISING PROMOTION (ADPROMO)

Company: SpringWorks Therapeutics
Location: Stamford
Posted on: August 24, 2024

Job Description:

About SpringWorks Therapeutics:

SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer.

SpringWorks has a diversified targeted oncology pipeline spanning solid tumors and hematological cancers, including clinical trials in rare tumor types and highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its lead product candidates into late-stage trials and enter into multiple collaborations with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer.

About the Role:

The Regulatory Affairs Advertising & Promotion Director is responsible for providing commercial regulatory strategy and leadership to enable the US business to meet its commercial needs in a compliant manner. Responsibilities pertain primarily to US marketing activities. The Director can be remote and will report to the Executive Director, Regulatory Affairs for Advertising Promotion. The Director will review promotional, corporate and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices.

This position must be capable of representing the commercial regulatory perspective at and chairing the Medical, Legal, Regulatory (MLR) review committee which includes cross functional partners from Marketing, Medical Affairs, and Legal. The Director will be required to assume a leadership role in advising cross-functional stakeholders on the commercial regulatory impact of new campaign concepts and product labeling and may also be required to provide strategic regulatory guidance on corporate communications and appropriate pre-approval communications. The Director will also serve as a liaison to the FDA's Office of Prescription Drug Promotion for respective product(s) and will help ensure materials are submitted to FDA in a timely manner.

Location Classification - Hybrid:

This role will be required to work onsite 2 days a week (Tuesday and Wednesday), or more depending on business needs. #LI-Hybrid

Key Responsibilities:

• Review and approve promotional, corporate and other non-promotional materials for relevant products and associated therapeutic areas.
• Represent the commercial regulatory perspective and rationale at regulatory project team meetings, labeling meetings, brand team meetings and, as needed, providing training to cross-functional colleagues including members of the MLR.
• Review and interpret enforcement letters, keeping current with industry changes relating to advertising and promotion, interpreting new Guidances to Industry, and, as applicable, evaluating related internal policies/best practices and processes.
• Provide strategic regulatory guidance on corporate communications and appropriate pre-approval communications.
• Serve as a liaison to the FDA's Office of Prescription Drug Promotion for respective product(s) and will help ensure materials are submitted to FDA in a timely manner.
• Perform other duties and responsibilities as assigned Qualifications:
  • Education: Bachelor's Degree within related discipline. Advanced Degree preferred
  • 9 years regulatory affairs experience within pharmaceutical or biotechnology industry
  • 5 years' experience in regulatory affairs Ad/Promo preferred
  • Oncology, rare disease, and/or other relevant therapeutic area experience is desirable. Must be capable of developing and implementing commercial regulatory strategy and managing complex negotiations with internal and external stakeholders.
  • The position will be recognized as a knowledgeable resource for commercial regulatory
  • Direct experience working with FDA's Office of Prescription Drug Promotion or Advertising and Promotional Labeling Branch is preferred.
  • Experience in leading cross functional teams and advising Company stakeholders on changes in regulations, policies, and enforcement which may impact the Company's promotional activities.
  • Proven ability to lead and influence data-driven strategy planning and implementation.
  • Strong leadership and communication skills with success in influencing all levels cross-functionally.
  • Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams' performance.
  • Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.
  • Ability to travel occasionally including overnight stay driven by business need.ompensation: The expected salary range for this position is $167,375.00 - $220,000.00. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
    
    We also offer a comprehensive benefits package for our team of SpringWorkers and their families, including competitive compensation, annual cash bonuses and equity grants, 401K matching, fully covered medical, dental, and vision plans, and a full week of holiday break at year end. It's the right thing to do - and helps us be healthy, happy, and at our best for the people who need us.
    
    SpringWorks Leadership Principles:
    • Change Steward - Recognize that change is essential; set goals that align to the Company's strategy and create positive momentum for change; adapt business practices as necessary to adjust to ever changing requirements
    • Excellence Driver - Drive high performance and ownership through an open dialog; recognize performance, empower teams and create accountability for results
    • Growth Coach - Set clear expectations, provide frequent feedback, coaching, and encourage continuous learning; leverage individual strengths to help SpringWorkers unleash their potential and grow in their jobs and careers
    • Community Builder - Establish connections with others to build strong teams that trust each other and are great at collaborating to achieve goals; create a diverse, inclusive, and psychologically safe environment
      DE&I:We believe in fostering a culture of belonging. Explore how we are committed to DE&I
      
      EEO Statement:
      SpringWorks maintains an EEO Policy providing for equitable opportunities for employment and conditions of employment to all employees and applicants regardless of actual or perceived sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender, gender identity or gender expression, sexual orientation, partnership status, marital status, familial status, pregnancy status, race, color, national origin, ancestry, caste, religion, religious creed, age, alienage or citizenship status, veteran status, military status, physical or mental disability, past or present history of mental disorder, medical condition, AIDS/HIV status, sickle cell or hemoglobin C trait, genetic predisposition, genetic information, protected medical leaves, victims of domestic violence, stalking, or sex offense, political affiliation and any and all other characteristics or categories protected by applicable federal, state or local laws. SpringWorks treats all employees and applicants fairly in the selection process (and in other personnel activities) by giving all employees and applicants the same opportunities for employment. SpringWorks' Equal Employment Opportunity Policy is intended to ensure that there are no barriers that would prevent members of a protected group from a fair and equitable opportunity to be hired, promoted, or to otherwise take advantage of employment opportunities.
      
      This Equal Employment Opportunity Policy applies to all aspects of employment, including, without limitation, recruitment, hiring, placement, job assignment, promotion, termination, transfer, leaves of absence, compensation, discipline, and access to benefits and training. Any violation of this Policy will result in disciplinary action up to and including termination of employment.
      
      For more information see our Privacy Policy - Springworks (springworkstx.com)

Keywords: SpringWorks Therapeutics, Stamford , DIRECTOR, REGULATORY AFFAIRS FOR ADVERTISING PROMOTION (ADPROMO), Executive , Stamford, Connecticut