Regulatory Advertising and Promotions Specialist

Proclinical is currently recruiting for a Regulatory Advertising and Promotions Specialist with a biopharmaceutical company located in Durham, NC.

Job Responsibilities:

• Provides functional input on key initiatives impacting other areas.
• Leads the implementation of risk management strategies and risk management plans for global Regulatory advertising and promotion.
• Provides global regulatory position, perspective, and expertise related to advertising and promotion to internal and external customers/ business partners.
• Maintains current knowledge of global codes of practice, regulations and guidance that impact pharmaceutical advertising and promotion.
• Has direct international (ex-US) accountability for assigned therapeutic areas within the Regulatory Advertising and Promotion department. Implements department
• policies and procedures, and significantly contributes to the development and updates to Divisional and
• Corporate policies effecting global core messaging.
• Supports departmental and business strategies, quality initiatives, compliance with policies and procedures, and the implementation of improvement plans.
• Contributes to the evaluation of departmental needs and implements solutions to enhance and facilitate operations.
• Provides critical analysis and potential interpretations of the regulatory position and messaging for communications in response to often highly
• visible pharmaceutical news having political, financial and legal interests.
• Creates an environment to attract, retain, empower and mentor leaders in business knowledge, management skills, and continued development.
• Provides strategic input into comprehensive training program.
• Negotiates/resolves the majority of decisions with Marketing, Medical, Legal, Public Affairs and Compliance counterparts.
• Collaborates and communicates effectively through all levels of management across multiple divisions and functions.
• Is recognized by organizational counterparts as a key company resource on pharmaceutical advertising and
• Applies novel and creative methods to problem solving.
• Constantly searches for out of the box solutions while maintaining quality and adherence to regulations.
• Balances business needs and risk assessments with creative decision-making abilities.
• Responsible for assigned marketed and development compounds advertising and promotion strategies.
• Has accountability for: the sound representation of global Regulatory Advertising and Promotion position within and external; and the operations, initiatives, and strategies for the regulatory Advertising and Promotion department.
• Leads cross-functional/ multidisciplinary/therapeutic teams.
• Demonstrates compliance with international codes of practice relevant regulations and manages financial business goals.

Skills and Requirements:

• 2-5 years of pharmaceutical experience a minimum of 1 year advertising and promotion regulatory
• experience preferred but may consider medical/scientific affairs with a of minimum 5 years direct
• advertising and promotion review experience.
• Minimum Bachelor's Degree (or equivalent) in science (biology, chemistry, microbiology,
• immunology, medical technology, pharmacy, pharmacology), is required.
• The candidate must have a solid understanding of regulatory advertising and promotion regulations, having
• had direct responsibility in this area.
• Master's, Ph.D or Pharm D preferred
• International experience desired but not required

If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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