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Job Details

Regulatory Labeling, Advertising and Promotion Scientist, US

Company: RBW Consulting
Location: Atlanta, GA
Reference: raa-raadpromo-sga
Closing Date: 28 Feb 18
Type: Full Time
Salary (£): 100,000+
Benefits: Competitive Benefits Package

Job Summary:

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Requirements:

Regulatory Labeling, Advertising and Promotion Scientist, US

Atlanta, GA

Provide oversight of the US labeling  process, including generation of new labeling and changes to existing labeling, and submission of labeling information to the FDA, and for the regulatory review and submission of  advertising and promotional materials for all client products marketed in the US.

Responsibilities:

  • Develop and maintain current knowledge of US regulation of labeling and industry standards for labeling and communicate requirements to others as needed.
  • Direct the labeling control process for tracking, implementation and regulatory submission of changes to existing labeling. 
  • Provide Regulatory guidance on clinical trial design in product development project teams to enable promotion of clinical trial data and desired product claims. 
  • Direct the production of new labeling text in conjunction with Regulatory Science Leads and Scientists.  Ensure that new labeling text meets regulatory labeling requirements.
  • Interface with the Global Labeling Function to ensure consistency of labeling processes and local compliance with CCDS.
  • Direct submission of labeling materials and supporting documentation to regulatory agencies in accordance with submission requirements.
  • Oversight of Labeling Review Committee activities.
  • Serve as US Labeling expert in Regulatory Affairs sub teams for activities related to the development of labeling for regulatory submissions.
  • Serve as US Labeling expert in Global Labeling Committee meetings and advises on FDA requirements and historical FDA labeling negotiations to support GLC discussions as needed.
  • • Develop and maintain current knowledge of requirements for US regulation of drug marketing and advertising and competitive landscape.  Communicate FDA requirements to other  departments involved in the preparation or review of external communication materials.
  • Collaborates with originators and cross functional team in the development of new promotional initiatives/programs and reviews supporting materials ensuring compliance and consistency with internal policies, Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the Federal Food, Drug, and Cosmetic Act.  Negotiates promotional regulatory position within cross-functional team.
  • Directs coordination of complex OPDP submissions in collaboration with Regulatory Labeling, Advertising and Promotion Manager, US
  • Direct the regulatory review of non-promotional scientific information, and external communication materials, including media information and provides proactive feedback

Requirements:

  • Bachelor’s degree in Science or related discipline; Master’s degree preferred
  • At least 8 years of relevant experience in the pharmaceutical industry with preferably 6 years in Regulatory Affairs and specific experience in US labeling and promotion
  • Extended knowledge of US labeling and promotion regulations and guidance.
  • Extended knowledge of science and data of assigned products and how that translates into labeling language.
  • Extended knowledge of competitive landscape and how other companies are dealing with similar issues in labeling and promotion.
  • Experience of product launch preferred.
  • Experience with device labeling preferred.
  • Expanded understanding of BioPharma business.
  • Demonstrated expertise in technology systems utilized for electronic documentation, including, but not limited to: Microsoft Office, Adobe Acrobat and Mikado.

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Apply for this job: Regulatory Labeling, Advertising and Promotion Scientist, US

Contact Information:

Address:  US Team
210 Broadway #201, Cambridge, Massachusetts,
02139
USA
Tel:  (617) 982 1238
Website:  Visit Our Web Site

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