Reviewer, Regulatory Affairs Advertising & Promotion

Founded in 2000, Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S. We have licensed our products in the US and international markets and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation.  Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success.  But of equal importance to each member of the team is how we interact with one another on a daily basis.  We believe in each other and we believe in respectful, open, and honest communications to help support individual and team success. 

Our Regulatory Affairs Advertising & Promotion department located in our Monmouth Junction, NJ headquarters has an immediate need for a Reviewer, Regulatory Affairs Advertising & Promotion.

Job Summary

The Reviewer, Regulatory Affairs Advertising & Promotion (RPDP) supports advertising and promotion efforts across company business units working closely with Head, RPDP and assisting Regulatory Affairs in achieving departmental goals and objectives. The incumbent builds on their pharmaceutical experience and/or education to expand their technical and business knowledge while actively contributing to, and supporting, the development, maintenance and monitoring of assigned Regulatory Affairs Advertising and Promotion projects and programs. 

Under direct supervision of, and collaborating closely with Head, RPDP, or designate, and cross-functional colleagues the incumbent handles and supports Regulatory review of assigned Corporate, Medical or Commercial communications, including but not limited to: Professional and Consumer product promotion, disease state information and Sales Training material, etc. 

ESSENTIAL FUNCTIONS

· Reviews external communications intended for healthcare professionals (HCPs) and patients/caregivers to ensure content is high-quality, truthful, accurate and compliant with applicable US laws, Food and Drug Administration (FDA) regulations and guidance, Pharmaceutical Research and Manufacturers of America (PhRMA) principles and company policy and process

· Collaborating closely with appropriate senior Regulatory Affairs colleagues, assists in analysis of proposed content, evaluates promotional claims and provides sound regulatory advice and recommendations to Commercial function and other departments, as needed 

· Ensures product promotion is consistent with FDA approved labeling

· Under direction and training from senior Regulatory Affairs colleagues prepares and ensures timely submission of promotional material under Form FDA 2253

· Assists in strengthening, streamlining, and developing relevant processes and best practices

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Minimum education and years of relevant work experience required

Bachelors degree in a life-science field including relevant pharmaceutical or biotechnology experience 

Special knowledge or skills needed and/or licenses or certificates required

· Knowledge of pharmaceutical/biotechnology industry (i.e., Medical/Clinical Affairs, Regulatory Affairs, Commercial, Product Development, etc.) acquired through industry and/or academic experience

· Ability to quickly learn, understand and explain complex medical and scientific information

· Excellent proofreading ability

· Strong interpersonal skills

· Proficiency with Microsoft Office 

· Excellent verbal and written communication and skills

· Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members

· Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines 

· Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

· Fluent in English (verbal and written)  

Special knowledge or skills needed and/or licenses or certificates preferred

• Advanced scientific degree (i.e.,      Masters, PhD, PharmD or MD)
• Hands on exposure/experience      performing Regulatory/Medical review of promotional material

Travel requirements

0-5 %

Physical requirements

Office based position

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-DNI