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Job Details

Regulatory Affairs Specialist - Ad Promotion

Company: RBW Consulting
Location: Missouri, USA
Reference: raa-raslap-musa
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 Affairs Specialist - Ad Promotion

Missouri, USA

Responsibilities:

  • Collaborate with marketing and medical education groups on strategies for new promotional materials.
  • Review and approve advertising, promotional and educational materials for compliance with regulatory requirements.
  • Apply regulatory and therapeutic area knowledge to marketing objectives and initiatives to develop solutions to complex US promotional issues. Ensures regulatory compliance while effectively managing business risks. 
  • Support development of exhibition booth content for US and International conferences.
  • Support development and maintenance of product and therapy claims matrices.
  • Champion internal advertising and promotion processes improvements.
  • Interface with Medical Affairs on questions regarding unapproved uses.
  • Maintain current versions of brief disclosures and fair balance language for DBS products.
  • Support new product development regulatory lead as a consultant on advertising and promotional requirements and best practices.
  • Provide internal training to regulatory affairs and other stakeholders as needed on advertising and promotion concepts.
  • Maintain current knowledge of industry and regulatory requirements, guidance and trends related to advertising and promotion. Monitor US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters and by attendance of appropriate FDLI, DIA and other industry/FDA meetings. 
  • Maintain awareness of competitive activities. 
  • Team with business unit Regulatory Affair Specialists to share best practices related to advertising and promotion and drive consistency across reviewers. 
  • May also provide support to currently-marketed products as necessary. This includes reviewing labelling, product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status. 
  • Ensure personal understanding of all quality policy/system items that are personally applicable.  Follow all work/quality procedures to ensure quality system compliance and high quality work.
  • May mentor or supervise other RAS, as directed by manager.

Qualifications:

  • Bachelor’s Degree
  • 7+ years of job-related experience with Bachelor’s degree or 
  • 5+ years of job-related experience with Master’s degree or
  • Experience working with medical device or pharmaceutical regulatory submissions
  • Experience performing advertising and promotion reviews for medical devices
  • Medical device experience strongly preferred
  • Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
  • Effective interpersonal skills
  • Effective team member
  • Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
  • Ability to effectively manage multiple projects and priorities.
  • Proficient computer skills 
  • Experience with Class III medical devices (510(k), PMA, IDE)
  • Clinical or statistical experience
  • Experience with FDA and international regulatory agency requirements, ISOIGHTF standards
  • Project management skills

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 Affairs Specialist - Ad Promotion

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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