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Regulatory Advertising & Promotion Project Manager

REMOTE, IL 00000

Posted: 08/25/2022 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 510466 Country: United States Is job remote?: Yes

Job Description

International Regulatory Advertising & Promotion safeguards products and practices to adhere to the highest quality and regulatory standards. Designs and delivers optimized global regulatory strategies, plans and dossiers that align with overall business strategy. Responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching global regulatory strategy and global brand plan. Leads the international regulatory strategy for the assigned marketed and development compounds. Interface with International Marketing, Global Legal and Office of Ethics and Compliance with regard to advertising and promotion strategies and tactics intended for use globally. Reviews and evaluates the global industry environment (e.g., regulatory, legal, and political climate), and plans strategically for overall system of regulatory communications.

Responsibilities:
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
• 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 guidances 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 promotion. 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.

Qualifications:
List required and preferred qualifications up to 10). Include education, skills and experience.
• 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 Bachelors 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

?*CO candidates may not be considered
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