Director/Senior Director, Advertising, Labeling & Promotion

Cubist Pharmaceuticals - Greater Boston Area

Posted 733 days ago
  • Experience
    Director
  • Job function
    Science, Other, Advertising
  • Employment type
    Full-time
  • Industry
    Biotechnology, Pharmaceuticals
  • Job ID
    3754653

This is a preview of the Director/Senior Director, Advertising, Labeling & Promotion job at Cubist Pharmaceuticals. To view the full job listing, join LinkedIn - its free!Join LinkedIn - its free!

About this job

Job description

The Director will establish and lead the Regulatory Advertising, Labeling and Promotion function at Cubist Pharmaceuticals. The Director will be responsible for providing strategic regulatory leadership to corporate activities related to product communication, labeling and labeling maintenance.

 

Specific responsibilities will include:

  • Lead regulatory processes, procedures and training to ensure corporate communication related to products in the market and in development are in compliance with applicable laws, regulations and corporate policy.
  • Provide strategic regulatory direction to Commercial, Medical Affairs and others for development of advertising and promotional materials that support corporate goals and comply with applicable regulations.
  • Communicate and negotiate with FDA Office of Prescription Drug Promotion (OPDP) on behalf of Cubist 
  • Develop and maintain global product labeling, including prescribing information and core labeling
  • Direct and develop the regulatory staff reporting to position

Short Term Goals:

  • Provide strategic advertising and promotion support for marketed products Cubicin, Entereg and co-promote product, Dificid
  • Review current policies, processes and procedures related to advertising, labeling and promotion, and initiate updating, as appropriate
  • Forge strong working relationships with marketing, medical affairs and legal staff

Long Term Goals:

  • Build global advertising, labeling and promotion function, beginning with Europe

Desired Skills and Experience

 Minimum Basic Qualifications:

  • BA/BS Degree
  • 11 years of pharmaceutical industry experience, including 6 years regulatory affairs experience
  • Working knowledge of evolving US FDA regulations and their interpretation relevant to pharmaceutical advertising and promotion
  • International labeling and advertising experience

Preferred Qualifications and Experience:

  • Graduate degree in life or health sciences
  • Supervisory experience, ideally of multi-disciplinary team
  • Experience and a demonstrated track record of issue resolution with OPDP/DDMAC.

Competencies:

  • Demonstrates confidence in one’s convictions and the integrity to express oneself to peers and leadership.
  • Reflects and leverages understanding of the external environment to identify possibilities and create opportunities.
  • Flexibility adapting strategies and tactics, based on external perspective, in order to get essential processes and practices in place, make improvements, and achieve organizational success.
  • Support the success of the group by providing clarity, support and tools needed to excel as things change while ensuring that the team has the skills and behaviors to meet strategic goals.

Work Environment:

  • Office

Physical Demands:

  • None

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above.  Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

About this company

Cubist Pharmaceuticals

Cubist Pharmaceuticals (NASDAQ: CBST) is a biopharmaceutical company focused on the research, development and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. The company is headquartered in Lexington, Massachusetts. In the U.S., Cubist markets CUBICIN® (daptomycin for injection), the first IV antibiotic from a class of antiinfectives called lipopeptides.

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