Please note this is hybrid role with three days/week in the Bridgewater, NJ office.
Overview
Reporting to the Senior Director, Medical Information, and Medical Operations, the Medical Information Manager is primarily responsible for serving as the primary Medical reviewer for promotional materials and for generating standard and customized medical information content to fulfill unsolicited Medical Information requests from both healthcare professionals (HCPs) and non-HCPs (including patients and consumers). They are responsible for creating and executing the content generation plan for the assigned therapeutic area. The Medical Information Manager also serves as the internal expert on literature related to assigned therapeutic areas and has related responsibilities across functions. The role will interface with multiple cross-functional teams including pharmacovigilance, quality, medical directors/leads, field medical team, commercial, regulatory, legal, and clinical development as well as external partners.
Responsibilities
Serves as the lead Medical reviewer for the Medical and/or Promotional review committee.
Responsible for the development of Medical Information materials (e.g., standard response documents, custom response documents, technical response documents, frequently asked questions) for external customers and internal business partners that are accurate, relevant, scientifically balanced, and in accordance with relevant SOPs and regulations.
Responsible for the creation and execution of the content generation plan for the assigned therapeutic area, including preparation of a content generation plan to support a product launch.
Management of internal and external resources for the execution of the content generation plan.
Provides timely, accurate, thorough, and scientifically-balanced responses to escalations from the Medical Information Contact Center (MICC).
Provides on-going support and training to MICC agents and other relevant individuals on new or updated Medical Information content.
Regularly monitors the quality and accuracy of the Medical Information responses and identifies necessary corrective actions or training required to ensure compliance with regional and local regulations as well as internally relevant SOPs.
Develop and maintain a deep knowledge of product, disease state, and competitor knowledge for assigned therapeutic area.
Mentor post-doctoral fellows, interns, and/or other learners.
Serve as a Medical Information resource for internal business partners.
Ensures prompt and accurate reporting of adverse events or product complaints in accordance with relevant SOPs and regulations.
Ensures compliance to Medical Information standard work practices and operating procedures.
Support audit readiness for Medical Information.
Act in full compliance with all laws, regulations, and policies including adverse events / pharmacovigilance responsibilities.
Perform other duties as assigned.
Education and Experience
An advanced degree in pharmacy, nursing, or medicine (PharmD, NP, DNP, MD, PA) from accredited US or foreign medical school is required.
A minimum of 3 to 5 years of experience in Medical Information or Medical Communications with a pharmaceutical company / vendor, including medical review of promotional materials.
Product launch experience is preferred.
Completion of a pharmaceutical industry fellowship or a drug information residency is preferred.
Experience with rare diseases is preferred.
Knowledge of applicable regulatory and legal requirements for the provision of medical information in the pharmaceutical environment
Knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing medical information in post-marketing products
Demonstrated ability to work in a matrix environment.
Demonstrated ability to produce clear, concise, and effective written and verbal communications describing scientific and clinical data in English.
Demonstrated advanced medical information skills (e.g., literature searching, literature evaluation, data analysis, statistics)
Start-up or small company experience is preferred.
Knowledge and Skills
Ability to build an excellent partnership with an outsourced partner, maintaining strong relationships while simultaneously holding the outsourced partner to high standards.
Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details.
Ability to work collaboratively and coordinate the efforts of team members to resolve comments and produce a final high-quality document.
Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.
Excellent computer skills. Strong proficiency in Microsoft programs: Excel, Word, PowerPoint, as well as Veeva systems