BioSpace
Senior Manager US Advertising & Promotion Lead
BioSpace, King Of Prussia, Pennsylvania, United States, 19406
Senior Manager US Advertising & Promotion Lead
CSL Behring —global biotherapeutics leader—seeks a Senior Manager US Advertising & Promotion Lead. The position is hybrid (onsite three days a week) and available at King of Prussia (PA), Waltham (MA), Zurich (CH), or Maidenhead (UK). The role reports to the Head, Global Advertising & Promotion.
Position Purpose
Provide an overview of the responsibilities of the position by summarizing the most important aspects and duties.
Ensure compliance with HA drug promotion and promotional labeling regulations for assigned licensed products.
Review, approve, or reject promotional programming based on U.S. Code of Federal Regulations and FDA implementing regulations and guidance.
Adhere to related SOPs and work instructions for established MCC/PRC processes.
Main Responsibilities And Accountabilities
Review advertising and promotional labeling; comment, improve, approve, or reject material based on company practice, CSL policy, U.S. law, and FDA regulations.
Collaborate with Commercial Operations Marketing, Legal, and Medical personnel to minimize HA enforcement risk while supporting CSL’s commercial success.
Monitor and apply trends in advertising and promotional labeling regulations to CSL U.S. regional review practices and processes.
Provide regulatory leadership and guidance to marketing during development, review, and approval of promotional materials for assigned therapeutic areas.
Prepare and submit advertising and promotional labeling materials to the FDA as required under 21 CFR 314.81(b)(3)(i) or 21 CFR 601.45.
Maintain technical biologics/medical knowledge for assigned therapeutic areas.
Actively contribute to the global CSL regulatory community through designated projects and assignments.
Review and advise product development teams on communication strategies or tactics regarding investigational products.
Experience
Bachelor's Degree in Life Science.
Minimum 3 years in Regulatory, Medical, or Legal Affairs or other relevant experience.
Skilled in implementing regulatory science and monitoring enforcement trends.
Ability to read and comprehend product-related technical and medical information.
About CSL Behring CSL Behring is a global biotherapeutics leader focused on saving lives. With strategic platforms in plasma fractionation, recombinant protein technology, and cell & gene therapy, CSL advances therapies across immunology, hematology, cardiovascular, metabolic, respiratory, and transplant areas. CSL operates one of the world’s largest plasma collection networks—CSL Plasma—and is headquartered in Melbourne, Australia with 32,000 employees worldwide.
Our Benefits For more information on CSL benefits, visit How CSL Supports Your Well-being at https://www.csl.com/careers/benefits.
You Belong at CSL Inclusion and belonging are core to our mission. By celebrating differences and fostering curiosity, we better serve patients, donors, and stakeholders, advancing a diverse workforce into the future.
Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Marketing and Sales
Industries
Internet News
#J-18808-Ljbffr
Position Purpose
Provide an overview of the responsibilities of the position by summarizing the most important aspects and duties.
Ensure compliance with HA drug promotion and promotional labeling regulations for assigned licensed products.
Review, approve, or reject promotional programming based on U.S. Code of Federal Regulations and FDA implementing regulations and guidance.
Adhere to related SOPs and work instructions for established MCC/PRC processes.
Main Responsibilities And Accountabilities
Review advertising and promotional labeling; comment, improve, approve, or reject material based on company practice, CSL policy, U.S. law, and FDA regulations.
Collaborate with Commercial Operations Marketing, Legal, and Medical personnel to minimize HA enforcement risk while supporting CSL’s commercial success.
Monitor and apply trends in advertising and promotional labeling regulations to CSL U.S. regional review practices and processes.
Provide regulatory leadership and guidance to marketing during development, review, and approval of promotional materials for assigned therapeutic areas.
Prepare and submit advertising and promotional labeling materials to the FDA as required under 21 CFR 314.81(b)(3)(i) or 21 CFR 601.45.
Maintain technical biologics/medical knowledge for assigned therapeutic areas.
Actively contribute to the global CSL regulatory community through designated projects and assignments.
Review and advise product development teams on communication strategies or tactics regarding investigational products.
Experience
Bachelor's Degree in Life Science.
Minimum 3 years in Regulatory, Medical, or Legal Affairs or other relevant experience.
Skilled in implementing regulatory science and monitoring enforcement trends.
Ability to read and comprehend product-related technical and medical information.
About CSL Behring CSL Behring is a global biotherapeutics leader focused on saving lives. With strategic platforms in plasma fractionation, recombinant protein technology, and cell & gene therapy, CSL advances therapies across immunology, hematology, cardiovascular, metabolic, respiratory, and transplant areas. CSL operates one of the world’s largest plasma collection networks—CSL Plasma—and is headquartered in Melbourne, Australia with 32,000 employees worldwide.
Our Benefits For more information on CSL benefits, visit How CSL Supports Your Well-being at https://www.csl.com/careers/benefits.
You Belong at CSL Inclusion and belonging are core to our mission. By celebrating differences and fostering curiosity, we better serve patients, donors, and stakeholders, advancing a diverse workforce into the future.
Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Marketing and Sales
Industries
Internet News
#J-18808-Ljbffr