- Title: Medical Advisor
- Code: RCI-03293
- Location: San Juan Puerto Rico (PR) 00936
- Posted Date: 11/24/2020
- Duration: 12 Months
- Name:Ankit Shah
- Email: Ankit.Shah@rangam.com
- Phone: 908-704-8843 ✖ 210
The Medical Advisor - Advertising and Promotional Review Committee (RC) will be responsible for the medical review of promotional materials for transplant and established products in collaboration with the RC, composed of representatives from medical, legal, regulatory, and marketing. This individual will be a member of the US Scientific Communications team as part of North America General Medicines Medical Affairs.
Required experience: strong knowledge of solid organ and stem cell transplant
Desired additional experience: prior experience as a medical reviewer for promotional materials
- Thoroughly review and evaluate promotional materials with associated references to ensure scientific and medical accuracy and integrity of all advertising and promotional materials in compliance with FDA and corporate regulations
- Understand medical and business strategy and integrated medical plans that support overall franchise goals of US Transplant products and established products.
- Work collaboratively with all members of the review committee to provide strategic input on the development of concepts, master visual aids, and all promotional and advertising materials for submission to the office of prescription drug promotion (OPDP)
- Identify and correct information inaccuracies and update materials according to most recent guidelines
- Organize and conduct meetings with originators and agencies to provide guidance on corrective measures for information inaccuracies and assist teams in the development of claims for advertising and promotional materials
- Advanced understanding and clinical knowledge of the disease state (particularly solid organ and stem cell transplant), scientific evidence regarding products, and technologies and services
- Advanced understanding of clinical trials methodology, outcomes, and limitations
- Through thorough review, ensure developed content demonstrate high degree of accuracy
- As member of RC committee and as part of RC review process, provides highly accurate medical and scientific information in connection with products
- Displays an exceptional ability to assimilate scientific data accurately, with strong learning agility, and to communicate such information clearly and with appropriate balance
- Communicate effectively to internal medical and business partners
Demonstrates Leadership, Collaboration and Self-Management Skills:
? Display advanced organizational and implementation skills and the capability to manage multiple priorities in a fluid, semi-independent setting
? Demonstrate advanced interpersonal skills, including expert oral and written communications capabilities for communication of scientific information
? Display strong interest in continuous learning of scientific knowledge
? Display forward strategic thinking, and the capability to communicate and support ideas effectively to RC committee members, Medical partners and matrix stakeholders
? Demonstrate excellent teamwork and partnership with RC Committee members and operates with a solution oriented approach
Demonstrate Compliance via Exceptional Understanding of and Adherence to Applicable Policies and Standards:
? Complete all required training, demonstrate a deep knowledge and understanding of relevant procedures, guidance’s, and adhere to corporate policies and procedures.
? Demonstrate accountability for all necessary and appropriate legal, regulatory, and compliance review of communication materials, research or other partnerships, or other types of activities. Collaborate effectively with the Medical Affairs and other colleagues, including the Standards and Quality Assurance teams, to understand and ensure adherence to relevant policies and standards
Doctoral level training (PhD, PharmD, MD) with expertise in solid organ and stem cell transplantation that combines professional experience with strong clinical background is required . The preferred educational background combines a foundational clinical degree with residency or fellowship experience.
At least 3-5 years of transplant experience and 2-5 years' experience in the pharmaceutical industry, with experience in promotional review
Strong scientific, health services and clinical pharmaceutical knowledge and experience, combined with an excellent understanding of the evolving US healthcare system and healthcare delivery.
Demonstrated ability to independently work under pressure in a compliant and highly regulated environment while managing multiple responsibilities
Ability to influence without authority in a highly matrixed environment
Strategic approach to problem-solving considering all of the potential implications of key decisions and messaging