Regulatory Affairs Associate Director Promotional Review for Oncology! Based in New Jersey (code USA 291020)

Reference: TM10542

Expiry Date: 29-12-2020

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Mercer County
United States

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Job Description

Regulatory Affairs Associate Director Promotional Review for Oncology! Based in New Jersey

This is a great role for an experienced Promotional review professional, who wants the challenge of working  in a dynamic and fast paced environment  which is highly competitive – but with huge rewards!

Ideally you will have excellent verbal, communication, and presentation skills and enjoying working in a fast paced, dynamic and changing environment where  your ability communicate effectively with cross functional teams and with business partners across the company will be fully utilized.

The role can be based in a number of sites on the East Coast, but the global Head Office is based in New Jersey, but other possible locations include Tampa, FL or New York City. Relocation is of course on offer if you require it but this can be held over and delayed ‘til Summer 21.

My client is a global Top 5 Bio/Pharma company with a strong (and highly interesting) Oncology pipeline and a highly rated and dedicated Regulatory leadership team. Due to continued pipeline growth, and successful registrations they are now expanding in a number of areas, including Regulatory Promotional Review. 

This is an Associate Director grade Regulatory Affairs Promotional Review role working in the fast paced and highly competitive Oncology market for a very active range of Solid Tumor products. You will be applying complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials for your assigned products/projects in order to help ensure the Company’s objectives are met.  

Although you will have full Promotional review responsibility for your own portfolio, you will be working with a tight-knit US Promotional review team, who are experienced, friendly and ready to jump in and support you as or when needed.  The cultural of the team is focused on sharing information, sharing ideas and always being available to provide a helping hand when needed -  this really is a collaborative team environment!

The Package & Salary available is definitely in the upper quartile of compensation and benefits, and comes with a strong performing RSU-based Share package, strong bonus, and relocation if needed. The company will also buyout existing stock and loss of bonus to encourage good candidates to apply today!

Responsibilities include:

  • Providing regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area
  • Providing solution oriented and innovative advice to meet the Company’s objectives and goals
  • Develop and maintain strong working relationships with internal customers, including Commercial, Medical, Public Affairs, Legal and Compliance
  • Integrate compliance considerations into risk assessment by partnering with Legal/Compliance colleagues
  • Provide advice and guidance as appropriate on the development of draft product labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based.

Qualifications:

  • BS required; advanced degree preferred (MS, PhD, PharmD, JD)
  • Minimum of 3-5 years Regulatory promotional review
  • Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed products and strong interest in FDA advertising and promotion regulations including guidance(s)
  • Ability to propose regulatory strategies for advertising Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns.

Proven aptitude to analyze and interpret efficacy and safety data.

To Apply!

To apply, please contact Theo Moore on US toll-free 855 505 1382, or send a full CV to Theo@AdvTalent.com and we will reply by return. Alternatively, please press the red “Apply for position” button and follow the registration process.

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