Associate Director, Promotional Materials (Legal)

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho's success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It's our work, our passion, and our legacy. We invite you to join us.  

Hybrid  

Employee Value Proposition: 

This is an opportunity to apply experience and judgment to make direct and tangible contributions to Taiho's business activities to further our mission of improving the lives of patients with cancer.  This role is a key member of the promotional and medical materials review committees. 

Position Summary: 

​​The Associate Director, Promotional Materials will provide guidance to the Promotional Review Committee (PRC) and Medical-Legal Review (MLR) process by interpreting and applying relevant laws, regulations, and principles to the development of promotional materials and scientific exchange communications, reporting to the Company's Compliance Officer.

Performance Objectives: 

• Understand and collaborate with business partners, e.g., Commercial, Medical Affairs, to achieve their business goals and objectives while appropriately managing risk. 
• Review materials intended for promotional messaging and scientific exchange as well as providing guidance and support to brand and medical teams regarding communications strategy and planning.
• Review and approve 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.
• Stay up to date and inform key stakeholders of changes in regulations, policies, and enforcement that may impact the Company's promotional activities
• Maintain current awareness of new regulations, guidance, or enforcements to uphold compliance.
• Conduct benchmarking projects for new initiatives and/or activities.
• Review and evaluate industry environment; perform competitive intelligence on promotional materials and activities.
• Work with the PRC to review and approve non-promotional items such internal training documents and internal communications.
• Lead creation and maintenance of PRC policies and work instructions for review, approval, and maintenance of promotional materials.
• Review content and format of assigned documents, assuring compliance with corporate policies, federal regulations and guidelines, and product development objectives.
• Align and maintain effective communication channels with functional business units in order to coordinate and facilitate documentation required for submissions, ensuring that timelines are met.
• Prepare project and/or status reports as required.
• Manage relationships with relevant vendors/consultants. 

Education/Certification Requirements: 

• Advanced degree in life or health sciences (Pharm.D., PhD, MS) and/or healthcare professional license with significant experience in review of promotional materials required. 
• Formal legal training (JD) and/or minimum five years relevant experience in promotional review or Healthcare Compliance role preferred.   

Knowledge, Skills, and Abilities: 

• Minimum 5 years of industry experience with direct responsibility for review of promotional materials. 
• Ability to work independent of direct supervision and risk-based decision-making skills required.
• Excellent oral and written communication abilities as well as strong collaborative/emotional intelligence skills required.
• Current knowledge of FDA guidelines and regulations with an emphasis on promotional activities.
• Proven ability to prioritize and meet project deadlines.
• Strong attention to detail with the ability to check documents for accuracy as well as consistency
• Demonstrates clear and effective verbal and written communication with the ability to accommodate differing views
• Ability to influence and manage complex negotiations with internal and external stakeholders.
• General knowledge of Healthcare Compliance program structure and execution a plus.

The pay range for this position at commencement of employment is expected to be between $ 190,400 - $224,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, commissions, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.  

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 

#Location-Princeton,NJ