Director, Sr. Director Of Pharmaceutical Ad/Promo/Labeling - Regulatory Affairs

Company Profile:

At Verastem Oncology, our purpose is to create a world where no cancer patient ever runs out of options. This commitment is central to who we are as a company and the culture we nurture. We are laser focused in our efforts to establish avutometinib + defactinib as the backbone of therapy for RAS-mediated tumors. We look for people who share our perspective; when others see only a problem, we see an opportunity, when others give up, we step up. We partner with global leaders (and their teams!) and these relationships help us to serve the patients who need us most. We appreciate your candidacy for the Verastem Oncology team, and encourage you to learn more at www.verastem.com.

Summary:

We are seeking a highly skilled and motivated Director, Sr. Director of Pharmaceutical Ad/Promo/Labeling to join our dynamic team at Verastem Oncology. As a leader in the biotechnology industry, we are dedicated to developing innovative therapies that transform the lives of patients living with cancer. In this role, you will play a crucial role in helping us achieve that goal.

This position is responsible for carrying out planning, scheduling, and coordination of global Ad/Promo/Labeling submission obligations including prior approval submissions to FDA Office of Prescription Drug Promotion (OPDP) as appropriate. The incumbent will collaboratively lead regulatory colleagues, others from relevant functional departments within Verastem Oncology, and with external consultants and contractors in coming to appropriate decisions re ad/promo/labeling. The position will be essential in building and maintaining a world-class framework of compliance with FDA ad/promo/labeling regulations and expectations. The incumbent will support the Regulatory leader gaining agreements with the Commercial team at Verastem Oncology in launching new products and maintaining existing approved products. This position is a remote position with in-office meetings several days per month.

Essential Duties & Responsibilities:

• Responsible for the review, approval, and submission of US promotional materials

• Ensures materials are accurate, truthful and not misleading, presented in a fair and balanced manner, consistent with product labeling, well-substantiated by current and scientifically valid evidence, adherent to applicable advertising and promotion standards, and comply with all internal and external policies and procedures.

• Serves as a liaison with the FDA on issues related to advertising and promotional materials.

• Effectively communicates and manages potential regulatory issues and concerns with Senior Marketing, Promotional Review Team (PRT), Global Regulatory Affairs, Medical Affairs and Worldwide Product labeling.

• Drive promotional regulatory strategy in collaboration with Commercial, Promotional Review Team (PRT), Global Regulatory Liaisons, Medical Affairs and global Product Labeling. Actively participates in labeling and product development meetings.

• Works independently and recognizes when issues need to be elevated to Senior Management. Reviews and defines standards for promotion, including traditional and emerging promotional platforms.

• Develops and implements departmental strategic initiatives. Serves as resource to internal leadership on risk assessment for new commercial initiatives.

• Engages in appropriate activities to improve the regulatory environment through Agency Contacts: OPDP, APLB, and associations as appropriate.

• Enhances collaboration across the organization while developing and maintaining varied disciplines across multiple review committees.

• Provides mentoring and promotional regulatory training to team members.

Qualifications:

• Minimum bachelor's degree in Life Sciences or relevant field

• Minimum 10 years' experience working in a regulated, life science environment (pharmaceutical, biotechnology); 5 years or more experience working as Manager of Pharmaceutical Ad/Promo/Labeling

• Advanced working knowledge ad/promo/labeling regulations, guidance, and OPDP expectations

• Extensive knowledge of global submission requirements for accelerated approval applications

• Significant track record in leading staff in development of labeling and ad/promo materials in preparation for US commercial launch as well as other markets

• Proven experience in selection, implementation and use of the appropriate Regulatory Operations systems, vendors, and procedures

• Computer proficiency in Microsoft Office, including Word, Excel, PowerPoint, Project, and Documentum technology.

• Self-motivated, flexible, innovative, able to prioritize and multi-task while working in a fast-paced and demanding environment.

• Superior communication skills: oral, written, negotiation skills, and strong time-management. A critical and logical thinker with the ability to analyze problems, identify alternative solutions and implement recommendations for resolution.

• Sound understanding of information management concepts and tools needed to carry-out ad/promo/labeling priorities.

• Advanced knowledge of pharmaceutical development (CMC, Nonclinical, Clinical), with the ability to understand and interpret data/information and its practical application.

• Able to take ownership of assignments, proactively consulting other project team members and other department representatives for information or guidance, as necessary.

• Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels.

• Experience working with external consultants and contractors.