Job Title Promotional Review Associate
Location Jersey City New Jersey
Duration +3 Months
I. POSITION SUMMARY: The associate works cross-functionally to project manage the review process for advertising and promotional materials for approved drug products. The associate is responsible for ensuring the efficiency of the Promotional Review Committee (PRC) process, involving Legal, Regulatory and Medical teams, and for conformance with company policies and procedures.
II. PRIMARY JOB RESPONSIBILITIES:
1. Lead and manage cross-functional promotional review committee meetings. Build and manage meeting agenda as a partner to Marketing and facilitate meetings while memorializing PRC reviewer comments. The associate should be comfortable dealing with participants of varying levels and experience, and be able to steer productive meeting discussions. The associate is also responsible to manage all meeting logistics, including scheduling.
2. Manage all aspects of the review process for multiple brands. The associate works closely with Brand Marketing, the Promotional Review Committee (PRC), and the rest of Marketing Operations, to proactively identify and resolve issues and ensure that review is efficiently completed through all stages of the process. It is expected that associates will actively contribute to ongoing process and system development as subject matter experts.
3. Enable best practices and SOP conformance. Use experience and judgment to identify pieces that may not be consistent with best practices, company policies or FDA guidance. Associate also ensures that all SOP requirements are met.
4. Interface with Regulatory and Production departments to execute the OPDP 2253 submission process. The associate is responsible to help ensure that the submission package is correctly prepared and that all promotional pieces are submitted to OPDP prior to use and distribution.
III. POSITION QUALIFICATIONS:
• Experience working in a pharmaceutical or healthcare advertising environment.
• Familiarity with promotional review systems such as Veeva or Zinc strongly preferred
• Experience with note taking during PRC meetings preferred
• Excellent interpersonal and collaboration skills
• Project management skills and experience
• General understanding of FDA regulations for pharmaceutical advertising and promotion.
• Strong presentation and meeting facilitation skills
Bachelor’s Degree and minimum of One year of experience
Mandatory Skills:
Interface with Regulatory and Production departments to execute the OPDP 2253 submission process. The associate is responsible to help ensure that the submission package is correctly prepared and that all promotional pieces are submitted to OPDP prior to use and distribution
Location Jersey City New Jersey
Duration +3 Months
I. POSITION SUMMARY: The associate works cross-functionally to project manage the review process for advertising and promotional materials for approved drug products. The associate is responsible for ensuring the efficiency of the Promotional Review Committee (PRC) process, involving Legal, Regulatory and Medical teams, and for conformance with company policies and procedures.
II. PRIMARY JOB RESPONSIBILITIES:
1. Lead and manage cross-functional promotional review committee meetings. Build and manage meeting agenda as a partner to Marketing and facilitate meetings while memorializing PRC reviewer comments. The associate should be comfortable dealing with participants of varying levels and experience, and be able to steer productive meeting discussions. The associate is also responsible to manage all meeting logistics, including scheduling.
2. Manage all aspects of the review process for multiple brands. The associate works closely with Brand Marketing, the Promotional Review Committee (PRC), and the rest of Marketing Operations, to proactively identify and resolve issues and ensure that review is efficiently completed through all stages of the process. It is expected that associates will actively contribute to ongoing process and system development as subject matter experts.
3. Enable best practices and SOP conformance. Use experience and judgment to identify pieces that may not be consistent with best practices, company policies or FDA guidance. Associate also ensures that all SOP requirements are met.
4. Interface with Regulatory and Production departments to execute the OPDP 2253 submission process. The associate is responsible to help ensure that the submission package is correctly prepared and that all promotional pieces are submitted to OPDP prior to use and distribution.
III. POSITION QUALIFICATIONS:
• Experience working in a pharmaceutical or healthcare advertising environment.
• Familiarity with promotional review systems such as Veeva or Zinc strongly preferred
• Experience with note taking during PRC meetings preferred
• Excellent interpersonal and collaboration skills
• Project management skills and experience
• General understanding of FDA regulations for pharmaceutical advertising and promotion.
• Strong presentation and meeting facilitation skills
Bachelor’s Degree and minimum of One year of experience
Mandatory Skills:
Interface with Regulatory and Production departments to execute the OPDP 2253 submission process. The associate is responsible to help ensure that the submission package is correctly prepared and that all promotional pieces are submitted to OPDP prior to use and distribution