Medical Advisor II, Vaccines (Remote) (s363)

Website Lenox Executive Search

Job Description:

The US Medical Advisor will serve as the medical reviewer of materials intended for use with external stakeholders. This individual will be a member of the US Vaccines Medical Operations team, reporting into the Head of Medical Operations & Excellence. Individual will be expected to:
• Ensure scientific and medical accuracy and integrity of all materials submitted for Medical Materials Review Committee (MMRC) and promotional Review Committee (RC) in compliance with FDA regulations and corporate policy/procedures
• Understand medical and business strategy and integrated medical plans that support overall franchise goals of US Vaccines
• Support content creation of medical materials, collaborating with medical colleagues

RESPONSIBILITIES of the Vaccines Medical Advisor:
• Provide medical review for external facing materials ensuring content, data, tables/graphs and reference accuracy and integrity
• 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 materials
• Provide recommendations to address any warnings that FDA might issue on US Vaccines-sponsored materials
• Assist medical directors on as needed basis with other medical projects
Demonstrate Strong Scientific/Technical Expertise:
• Advanced understanding and clinical knowledge of the disease state, scientific evidence, and clinical data regarding Sanofi vaccines
• Advanced understanding of clinical trials methodology, outcomes, and limitations
• Demonstrate high level of accuracy with material reviews and developed content
Effective Communication:
• Display 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 and external 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 and 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 review committee members, medical partners and matrix stakeholders
• Demonstrate excellent teamwork and partnership with 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 company relevant procedures, guidance’s, and adhere to corporate policies and procedures.
• Demonstrate accountabilities 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 and other colleagues to understand and ensure adherence to relevant policies and standards

BACKGROUND AND JOB-RELATED EXPERIENCE:
• Minimum Amount of Job-Related Experience: A minimum of 3 years of prior experience in pharmaceutical industry or medical communications, with a history of successful performance

REQUIREMENTS of the Vaccines Medical Advisor:

  • Pharm.D./PhD/MD
    • Vaccine experience strongly desired
    • 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 the potential implications of key decisions and messaging
    • Experience with clinical health care delivery in the United States and biotechnology drug or vaccine development process
    • Exceptional oral and written communication skills
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