Cynet systems Inc
Senior Medical Information Specialist
Cynet systems Inc, Convent Station, New Jersey, us, 07961
Job Description
Pay Range: $45.27/hr - $50.27/hr
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.
Manages and maintains scientifically accurate response documents for Consumer.
Healthcare (CHC) products 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.
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.
Contributes to the identification and implementation of Client channels for dissemination of medical information, like chat bots, live chats, Apps etc.
Education
Science degree.
Advanced degree (PharmD, PhD, MD, MS) in a health care related field desirable.
Required knowledge and/or 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 of basic medical information requirements and compliance procedures and ability to.
Understand consumers point of view.
Knowledge of 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.
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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.
Manages and maintains scientifically accurate response documents for Consumer.
Healthcare (CHC) products 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.
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.
Contributes to the identification and implementation of Client channels for dissemination of medical information, like chat bots, live chats, Apps etc.
Education
Science degree.
Advanced degree (PharmD, PhD, MD, MS) in a health care related field desirable.
Required knowledge and/or 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 of basic medical information requirements and compliance procedures and ability to.
Understand consumers point of view.
Knowledge of 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.
#J-18808-Ljbffr