Regulatory Advertising and Promotions Specialist
Proclinical is currently recruiting for a Regulatory Advertising and Promotions Specialist with a biopharmaceutical company located in Cambridge, MA.
- 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.