Medical Information Specialist

Job Description

Job Summary:

• Manage and maintain scientifically accurate local and global response documents for client products.
• Support the team’s understanding and compliance with policies, procedures, and processes.
• Leverage regional/local insights on content usage, to meet the need for new or updated content.
• Look for efficiencies to optimize content creation and update.
• Provide business stakeholders with actionable insights and recommendations based on knowledge of product/therapeutic area as well as customer interactions.
• Contribute to the identification and implementation of Client channels for dissemination of medical information.

Duties and Responsibilities:

• Lead and manage direct reports within the US Medical Information team, providing mentorship, performance oversight, and strategic guidance to ensure high-quality medical content and inquiry handling.
• Localizes global scientific response documents (GSRDs) with local content as needed.
• Writes and reviews global medical information content.
• Ensures the quality and integrity of responses provided to health care professionals, patients, and consumers in the US and globally.
• Manages inquiries and responds to local and global escalations.
• Assists in review of medical compendia and contributes to NDA annual reports.
• Provides summaries of literature searches for NDA product annual reports for FDA submissions.
• Interacts with contact center team(s) and coordinates meetings, trainings and exchange as needed.
• Performs regular contact center quality checks in US.
• Supports training of support function staff and outsourced partner(s) as needed.
• Executes processes and participates in cross functional projects by contributing with product knowledge and intra-departmental relations, along with editing, writing, database, and file management proficiency.
• Collaborates with Medical, Regulatory, R&D, and Quality colleagues across the company to ensure appropriate responses using a state of art tracking and repository systems.
• Performs literature research and critically evaluate scientific data.
• Performs ongoing literature reviews and extracts complex data from scientific literature and arranges the data in an organized format.
• Ensures consistent and accurate product information.
• Serves as a knowledge resource for all colleagues located around the world.
• Suggests improvements or updates to existing policies, procedures, work instructions, and work guides used in internal operations and with external vendors as needed.
• Provides medically sound responses to complex inquiries forwarded from outsourced partner(s) and in-house sources and proposes solutions to identified issues.

Education:

• Science degree.
• Advanced degree (PharmD, PhD, MD, MS) in a health care related field desirable.

Required Experience:

• Minimum of 3 years of related technical experience with at least 1 year management in a Medical Information or equivalent department within the Pharmaceutical /Consumer Health Industries
• At least 1 year performing Medical Information related writing scientific response documents, responding to medical and non-medical related consumer healthcare product escalations.

Knowledge:

• Knowledge of basic medical information requirements and compliance procedures and ability to understand consumers point of view.
• Knowledge of client products, product labeling, and Federal Regulations pertaining to OTC and pharmaceutical products a plus.
• Knowledge of Sales Force CRM and Veeva Vault Medical/RIM a plus