Requisition ID 10616BR
Title Sr. Manager/Associate Director,Regulatory Affairs - Promotional Review
Job Category Regulatory Affairs
Job Description PURPOSE:
Manage the Regulatory review of Promotions and Advertisements for company marketed products.
RELATIONSHIPS:
Reports to the Director, Promotional Review. Works with other personnel in Marketing ,Marketing Operations, Regulatory, Medical Affairs, Sales, and Legal Departments in support of initiatives and Promotional Review Board (PRB) process and review of promotional materials. External relationships include interaction with FDA personnel regarding promotional issues. Develop and maintain positive rapport and working relationships within and across departments, including Marketing, in relation to promotional issues. Manages assigned junior personnel as direct reports. Attend FDA’s meetings and contribute to negotiations with FDA as necessary.
ESSENTIAL FUNCTIONS:
FDA COMPLIANCE:
Assure full regulatory compliance of all promotions with approved labeling.
Handle other duties and/or special projects as assigned by the Director/VP, Regulatory Affairs.
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.
Provide training in FDA regulations for advertising and promotion to employees and agents of Novo Nordisk.
Review of draft and final advertising/promotional materials for marketed products, as assigned.
Coordinate and supervise the development of regulatory strategies for investigational, new or modified pharmaceutical products.
Approve specified regulatory submissions
PRB PROCESS:
Assist the Director in development and implementation of strategy to maintain efficient and compliant PRB process.
Builds a strong relationship with internal customers; including Marketing, Marketing Operations, Legal and Medical.
Builds a strong relationship with the FDA
Other duties as deemed appropriate by Director, PRB.
Provide regulatory review of draft promotional materials (pre-PRB).
Regulatory PRB reviewer.
Support development of launch materials/new claims by collaborating with Marketing, Medical and Legal. Prepare FDA submissions of draft introductory promotional materials.
SUBMISSIONS:
Assure company compliance with FDA and FTC requirements and strategy.
Ensure timely and accurate submission of promotional materials to FDA in Form 2253.
Oversee preparation and submission of draft introductory materials to FDA for comment.
PHYSICAL REQUIREMENTS:
Some travel required.
DEVELOPMENT OF PEOPLE:
Ensure that reporting personnel have 3P forms, which have annual goals and measurements, are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities. Understand their level of accountability for results and the measurement process.
Ensure that the IDP forms (reporting personnel and own) include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management.
Review subordinates 3P and IDP’s.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
A Bachelors Life Science degree required; advanced degree preferred.
A minimum of eight (8) years pharmaceutical industry experience, including direct FDA Regulatory Affairs interaction (submissions and negotiations).
A minimum of two (2) years Regulatory Promotional Review experience required.
Detail & deadline oriented; well organized.
Excellent verbal & written communication skills.
Good interpersonal skills; ability to interact with staff on all levels.
Works independently with minimal supervision.
Department CMR - PROMOTIONAL REVIEW
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%
Title Sr. Manager/Associate Director,Regulatory Affairs - Promotional Review
Job Category Regulatory Affairs
Job Description PURPOSE:
Manage the Regulatory review of Promotions and Advertisements for company marketed products.
RELATIONSHIPS:
Reports to the Director, Promotional Review. Works with other personnel in Marketing ,Marketing Operations, Regulatory, Medical Affairs, Sales, and Legal Departments in support of initiatives and Promotional Review Board (PRB) process and review of promotional materials. External relationships include interaction with FDA personnel regarding promotional issues. Develop and maintain positive rapport and working relationships within and across departments, including Marketing, in relation to promotional issues. Manages assigned junior personnel as direct reports. Attend FDA’s meetings and contribute to negotiations with FDA as necessary.
ESSENTIAL FUNCTIONS:
FDA COMPLIANCE:
Assure full regulatory compliance of all promotions with approved labeling.
Handle other duties and/or special projects as assigned by the Director/VP, Regulatory Affairs.
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.
Provide training in FDA regulations for advertising and promotion to employees and agents of Novo Nordisk.
Review of draft and final advertising/promotional materials for marketed products, as assigned.
Coordinate and supervise the development of regulatory strategies for investigational, new or modified pharmaceutical products.
Approve specified regulatory submissions
PRB PROCESS:
Assist the Director in development and implementation of strategy to maintain efficient and compliant PRB process.
Builds a strong relationship with internal customers; including Marketing, Marketing Operations, Legal and Medical.
Builds a strong relationship with the FDA
Other duties as deemed appropriate by Director, PRB.
Provide regulatory review of draft promotional materials (pre-PRB).
Regulatory PRB reviewer.
Support development of launch materials/new claims by collaborating with Marketing, Medical and Legal. Prepare FDA submissions of draft introductory promotional materials.
SUBMISSIONS:
Assure company compliance with FDA and FTC requirements and strategy.
Ensure timely and accurate submission of promotional materials to FDA in Form 2253.
Oversee preparation and submission of draft introductory materials to FDA for comment.
PHYSICAL REQUIREMENTS:
Some travel required.
DEVELOPMENT OF PEOPLE:
Ensure that reporting personnel have 3P forms, which have annual goals and measurements, are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities. Understand their level of accountability for results and the measurement process.
Ensure that the IDP forms (reporting personnel and own) include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management.
Review subordinates 3P and IDP’s.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
A Bachelors Life Science degree required; advanced degree preferred.
A minimum of eight (8) years pharmaceutical industry experience, including direct FDA Regulatory Affairs interaction (submissions and negotiations).
A minimum of two (2) years Regulatory Promotional Review experience required.
Detail & deadline oriented; well organized.
Excellent verbal & written communication skills.
Good interpersonal skills; ability to interact with staff on all levels.
Works independently with minimal supervision.
Department CMR - PROMOTIONAL REVIEW
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%