FierceBiotech and FiercePharma Jobs
Director, Labeling and Promotion Compliance - The Cambridge Group Ltd.
Jul 28
Location: Westport, CTCategories: Pharmaceutical
Website: http://www.cambridgegroup.com
Position Description
Director, Labeling and Promotion Compliance
The incumbent to the Director, Labeling and Promotion Compliance position directs all aspects for labeling and the promotion of medical products. Provides operational oversight that all promotional materials, labeling, art, film, and plate proofs meet all medical, legal, and regulatory requirements and ensures awareness of evolving US regulatory initiatives that apply to labeling and promotional compliance. Job responsibilities are: directs and manages labeling and promotional compliance operations in the United States, including: reviews and determines labeling needs for all products, oversees resource allocation for products, reviews and approves labeling and promotional compliance processes and procedures, develops and implements new methods to improve the efficiency of the Labeling and Promotional Compliance Department, recommends courses of action on management and human resources matters in the department, including salary administration, promotions, transfers, hiring, terminations, training and development of managerial and professional staff, performance appraisals, position descriptions, and employee counseling, guides and directs the Labeling and Promotional Compliance staff in the achievement of their professional goals through training and regular mentoring, serves as liaison to government agencies on promotional compliance issues and interfaces with Medical Affairs and Legal Departments as well as Alliance Partners to resolve labeling and promotional compliance issues. The successful candidate will have the following skills experiences: expert knowledge of US regulatory labeling and promotional compliance requirements; essential understanding of global regulatory requirements, thorough knowledge of clinical medicine and/or clinical pharmacology with a strong understanding of medical concepts and terminology, complete understanding of drug indications, understands the company’s products, the competition, and the pharmaceutical industry in general, able to work across different therapeutic areas and different stages of clinical development, strong communication skills, strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). Education required includes: MD/PharmD/PhD with a minimum of 8 years of experience in promotional compliance and product labeling in the pharmaceutical industry.
