Sun Pharmaceutical Industries Ltd.
Sun Pharmaceuticals Industries Inc. is the fifth largest generic pharmaceutical company in the world, and rapidly building brand presence. We manufacture, market and distribute pharmaceuticals to the nation’s largest wholesalers, distributors, warehousing and non-warehousing chain drugstores as well as managed care providers. Our goal is to continue to develop and market quality products that bring value to our customers and ultimately the patient. Current manufacturing capabilities allow Sun Pharma to develop products across most therapeutic categories.
At Sun Pharma we believe our people are an invaluable asset. Our culturally diverse workforce is one of our biggest strengths, along with the rich experience they bring across varied skill-sets. We are proud that our global workforce is bound by our common values:
Humility. Integrity. Passion. Innovation .
Compliance Counsel will report to the head of healthcare compliance North America and work with the members of sons promotional review committee, referred to as the HC in a Medical Legal Regulatory (MLR) committee, to ensure completion of legal and healthcare compliance reviews of commercial and medical submissions to the MLR committee.
Responsibilities include providing overall assistance in reviewing sales marketing and commercial activities through the promotional and medical review process to ensure that materials and tactics are compliant with company policies and legal requirements.
Essential Job Functions:
⁃ Supporting commercial business units with the review and assessment of advertising and promotional issues through participation in the MLR review committee
⁃ Assessing disease state and medical materials through the MLR review committee
⁃ Providing healthcare compliance guidance for various therapeutic areas including Dermatology, Biologics, Neuroscience, Oncology and Ophthalmology
⁃ Advising company executives on healthcare compliance policies procedures and laws
⁃ Collaborating with Medical and Regulatory Affairs to conduct a detailed review and evaluation of the adequacy of promotional claims and tactics to ensure consistency with FDA approved labeling
Requirements and Qualifications:
⁃ 5 to 10 years broad experience in pharmaceutical industry and/or with pharmaceutical manufacturer activities is a REQUIRED
⁃ 5 years direct experience conducting legal reviews of advertising and promotional content and practical experience in interpretation of industry regulations and guidance documents
⁃ BS/BA degree required
⁃ Jurist doctorate degree required
⁃ Demonstrated knowledge of regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biological products
⁃ Must have knowledge and experience to act upon compliance issues related to sales marketing and medical affairs activities. Also, Government programs federal healthcare program reporting continuing medical education programs and overall business ethics programs
⁃ Knowledge of FD&CA, Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, PDMA, FDAAA, HIPAA, state laws
⁃ Regulations industry guidance and best practices regarding compliance sales marketing medical affairs activities
⁃ Must possess strong verbal written presentation and other communication skills
⁃ Ability to fully gauge various audiences
⁃ Proficiency Microsoft office is required
⁃ Must be self-motivated and possess strong interpersonal skills
Sun Pharmaceutical Industries Ltd.
Website : http://www.sunpharma.com/
Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business, economies of scale and an extremely skilled team enable us to deliver quality products in a timely manner at affordable prices. It provides high-quality, affordable medicines trusted by customers and patients in over 150 countries across the world. Sun Pharma's global presence is supported by 50 manufacturing facilities spread across 5 continents, R&D centres across the globe and a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising about 2,000 scientists and R&D investments of over 7% of annual revenues.