As a product and disease state expert within Medical Affairs, the candidate will provide medical, scientific and technical expertise to support product scientific communications planning and to provide essential medical support for the products.
Responsibilities
Creating, updating and/or reviewing medical information content on products to ensure complex scientific content is summarized in a concise, simple and balanced manner utilizing the highest level of evidence and critically evaluating the data and literature
Develop, review and maintain Medical Affairs materials including customized medical letters, standard response letters, publication library, and summarize any clinical papers in medical affairs library
Collaboration on company training materials for Medical Affairs
Maintain close interactions and liaise with Compliance, Clinical Development, Marketing, Sales and other internal stakeholders, as required
Coordinate development, review and approval of clinical Data on File packets to support promotional claims, as required
Contribute to the development, review and maintenance of Medical Affairs scientific materials, including Managed Market documents, in collaboration with Medical Affairs colleagues
Incorporate customer insight to identify, update, and develop new scientific materials in conjunction with Medical Affairs leadership
Respond to Medical Inquiries and provide support for field Medical Science Liaisons with appropriate scientific information for their exchanges with Health Care Providers via multiple channels (i.e. verbal, written)
Supply Medical Affairs field team information to provide to Healthcare Providers regarding the appropriate use and clinical differentiation of products.
Identify, analyze and/or report trends in medical and scientific insight (including Medical Inquiries) to Medical Affairs stakeholders
Actively participating in Medical Information Workstreams to develop best practices, ways of working and continuous development and improvement for Medical Information deliverables.
Maintain a high level of medical-scientific knowledge around infusion therapy advancements across therapeutic area(s) and/or disease state(s) involving clinical issues related to infusion therapies and products.
Identify practical issues, unmet needs, and competitive insights relevant to the use of products and work cross-functionally to create educational programs, tools, and solutions.
Qualifications
Relevant educational background with a PharmD, RPh, RN, PhD or similar
2-4 years of experience in pharmaceutical industry in drug information, preferably in Medical Affairs Drug Information Residency or equivalent experience.
Strong organizational skills, writing and time management. Medical information call center experience preferred but not required. Immunology, respiratory and Infectious Disease background a plus.
The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities.
This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.
Domestic travel is required approximately 50% of the time.
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