Reporting directly to the Director, Medical Communications, the Manager, Medical Information will collaborate with and provide superior professional support to the Organogenesis US Medical Information team by appropriately triaging, processing, and handling unsolicited inquiries from internal and external stakeholders related to any of Organogenesis’ assets and/or therapy areas. This position is accountable for the development and maintenance of a repository of high quality medical information standard response documents (SRDs) that are current, complete, accurate, and fair-balanced. The manager will develop, organize and centralize the process of collecting and sharing scientific information for Organogenesis, a company-wide library, and serve as the internal knowledge management expert/resource. Serve as the non-promotional review committee (NPRC) coordinator for facilitating the review approval of all externally-facing medical materials.
ESSENTIAL JOB FUNCTIONS/KEY RESPONSIBILITIES:
Provide timely, professional support to Organogenesis US Medical Information by triaging and responding to inquiries from internal and external stakeholders related to Organogenesis products and associated disease states.
Ensure extreme accuracy when triaging, handling and processing all Medical Information cases and that the corresponding documentation is as precise and comprehensive as possible when logging into the database
Triage, evaluate and identify initial reports of adverse events and product/technical complaints and forward potential adverse events and product/technical complaints in accordance with company SOP's
Cases (MI and non-MI specific) may come into OI US Medical Information through a variety of channels (including live calls/warm transfers, VMs, and/or emails, etc.). All cases, from initial intake, processing/ handling and completion, should be logged into the MI database in real time (for live calls, etc.) or as judiciously as possible (as determined on a case-by-case basis and per the initial method of contact)
Develop and maintain a repository of high quality standard (and customized) response documents (SRDs-standard response letters [SRLs] and FAQs) to be able to provide the most current, complete, accurate, fair-balanced, and timely responses to unsolicited medical information inquiries
Conduct comprehensive, targeted, and thorough literature and information searches (including databases, PubMed, government websites, etc.) to assist in the development/revision of MI response documents
Ability to critically evaluate and interpret emerging data/concepts within the medical/scientific literature. Assess accuracy, relevance and appropriateness of data for inclusion into new and existing SRDs and/or other educational materials
Participate in the creation of, and ensure adherence to, OI departmental policies and SOPs
Develop and maintain the Organogenesis library
Utilize a literature management solution (e.g., QUOSA) for OI to organize and centralize the process of collecting and sharing scientific information
Responsible for the timely discovery, retrieval, and distribution of all scientific and medical references of relevance (may pertain to any of Organogenesis’ assets, therapy areas, competitor data, etc.)
Develop and maintain a structured, up-to-date literature repository of medical/scientific literature references for internal stakeholder use
Procure and maintain annual journal subscriptions that are key to the business
Provide internal training on the OI library, literature management solution and repository, and the process for requesting/retrieving references
Responsible for procuring Annual Copyright License for OI to ensure complete compliance with all copyright clearance laws/regulations
Provide medical information booth support at key medical/scientific conferences (as required)
Serve as the non-promotional review committee (NPRC) coordinator
Schedule and facilitate meetings, accurately document all feedback/amends that are requested during review meetings pertaining to medical materials (e.g., MI response documents, medical slide decks, publication, etc.), provide all reviewer feedback/amends to initial requester for incorporation/consideration (as appropriate), and ensure final approval is obtained on all medical materials in a timely manner
Mentor and train new members of medical information group.
Advanced scientific degree required equivalent to PharmD, PhD, PA, MD/DPM, RN or advanced degree
Successful track record in medical information and/or medical affairs with a minimum of 2 to 4 years of medical information experience
Thorough understanding of federal regulations and guidance pertaining to medical information/communications processes and adverse event reporting
Excellent organizational, interpersonal, and communications skills
High degree of accuracy; eye for detail, fastidious
Self-motivated with exceptional follow through; resourceful; ability to think outside the box and see the bigger picture
Demonstrates flexibility and adapts well in response to changing needs and competing demands
Must be a strong team player and be willing to work in an environment where individual initiative and accountability to the team are required
Ability to effectively manage time while balancing numerous high-priority projects with a sense of urgency
Experience in wound care, regenerative medicine, and/or medical devices preferred
Sedentary work - Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body.
Visual Acuity - The employee is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; viewing a computer terminal; extensive reading and writing.