Requisition ID 16391BR
Title Manager/Sr. Manager, Reg Affairs - Advertising/Promotional Review
Job Category Regulatory Affairs
Job Description PURPOSE:
Manage and oversee all assigned Promotional Review projects. Assist the Sr. Manager, Regulatory Affairs – Promotional Review in assuring Novo Nordisk compliance with internal SOPs and Federal and State regulations, including compilation and submission of any required documents to regulatory agencies.
RELATIONSHIPS:
Reports to Sr. Manager, Regulatory Affairs-Promotional Review. Develop and maintain positive rapport and working relationships with other personnel in Regulatory Affairs, CMR, and other local and headquarter departments to accomplish company goals. External relationships may include interaction with FDA personnel regarding assigned projects and roles.
ESSENTIAL FUNCTIONS:
Assist the Director in development and implementation of strategy to maintain efficient and compliant PRB process.
Assure company compliance with FDA and FTC requirements and strategy, including timely and accurate submission of promotional materials to FDA in Form 2253.
Builds a strong relationship with internal customers; including Marketing, Marketing Operations, Legal and Medical.
Builds a strong relationship with the FDA
Maintain up-to-date knowledge of laws, regulations and policies enforced by the Federal and State governments as they relate to advertising and promotion of pharmaceuticals and devices. Advise appropriate departments within the company (NNI and NNAS) of these requirements.
Assist the Director in establishing procedures to assure compliance with these requirements
Review of draft and final advertising/promotional materials assuring full regulatory compliance of all promotions for all assigned products.
PHYSICAL REQUIREMENTS:
May require some overnight travel
DEVELOPMENT OF PEOPLE:
Not Applicable
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
EDUCATION AND EXPERIENCE:
A Bachelor’s degree required ( Life Science and advanced degree preferred) with a minimum of 4 years advertising/promotional review experience in the pharmaceutical industry
OR
PharmD with Fellowship focusing on advertising and promotions compliance and/or minimum of 2 years advertising and promotions compliance experience
Advanced knowledge of pertinent FDA regulations.
Detail & deadline oriented; well organized.
Excellent verbal & written communication skills.
Experience leading projects in specific regulatory area preferred.
Good interpersonal skills; ability to interact with staff on all levels.
Knowledge of diabetes and diabetes management beneficial.
Works independently with minimal supervision.
Department CMR - REG AFFAIRS (2a)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Title Manager/Sr. Manager, Reg Affairs - Advertising/Promotional Review
Job Category Regulatory Affairs
Job Description PURPOSE:
Manage and oversee all assigned Promotional Review projects. Assist the Sr. Manager, Regulatory Affairs – Promotional Review in assuring Novo Nordisk compliance with internal SOPs and Federal and State regulations, including compilation and submission of any required documents to regulatory agencies.
RELATIONSHIPS:
Reports to Sr. Manager, Regulatory Affairs-Promotional Review. Develop and maintain positive rapport and working relationships with other personnel in Regulatory Affairs, CMR, and other local and headquarter departments to accomplish company goals. External relationships may include interaction with FDA personnel regarding assigned projects and roles.
ESSENTIAL FUNCTIONS:
Assist the Director in development and implementation of strategy to maintain efficient and compliant PRB process.
Assure company compliance with FDA and FTC requirements and strategy, including timely and accurate submission of promotional materials to FDA in Form 2253.
Builds a strong relationship with internal customers; including Marketing, Marketing Operations, Legal and Medical.
Builds a strong relationship with the FDA
Maintain up-to-date knowledge of laws, regulations and policies enforced by the Federal and State governments as they relate to advertising and promotion of pharmaceuticals and devices. Advise appropriate departments within the company (NNI and NNAS) of these requirements.
Assist the Director in establishing procedures to assure compliance with these requirements
Review of draft and final advertising/promotional materials assuring full regulatory compliance of all promotions for all assigned products.
PHYSICAL REQUIREMENTS:
May require some overnight travel
DEVELOPMENT OF PEOPLE:
Not Applicable
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
EDUCATION AND EXPERIENCE:
A Bachelor’s degree required ( Life Science and advanced degree preferred) with a minimum of 4 years advertising/promotional review experience in the pharmaceutical industry
OR
PharmD with Fellowship focusing on advertising and promotions compliance and/or minimum of 2 years advertising and promotions compliance experience
Advanced knowledge of pertinent FDA regulations.
Detail & deadline oriented; well organized.
Excellent verbal & written communication skills.
Experience leading projects in specific regulatory area preferred.
Good interpersonal skills; ability to interact with staff on all levels.
Knowledge of diabetes and diabetes management beneficial.
Works independently with minimal supervision.
Department CMR - REG AFFAIRS (2a)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required