Manager of Medical Information

2 weeks ago

Washington, Washington, D.C., United States BESTMSLs Full time

Medical Information Manager

Job ID:
# of Openings: 1
Category: Medical Information
BESTMSLs

Overview

The Medical Information Manager plays a crucial role in developing both standard and tailored medical information content to address unsolicited inquiries from healthcare professionals (HCPs) and non-HCPs, including patients and consumers. This position involves creating and implementing a content generation strategy for the designated therapeutic area. Furthermore, the individual will act as the primary medical reviewer for promotional materials and will be regarded as the internal authority on literature pertaining to the assigned therapeutic areas, collaborating with various cross-functional teams such as pharmacovigilance, quality assurance, medical directors, field medical teams, commercial departments, regulatory affairs, legal, and clinical development, as well as external partners.



Key Responsibilities
  • Develop comprehensive Medical Information materials (e.g., standard response documents, customized response documents, technical response documents, frequently asked questions) for both external clients and internal stakeholders, ensuring accuracy, relevance, and scientific balance in accordance with applicable SOPs and regulations.
  • Create and execute a content generation strategy for the assigned therapeutic area, including preparation for product launches.
  • Oversee the management of internal and external resources necessary for the execution of the content generation strategy.
  • Provide timely, accurate, and scientifically balanced responses to escalations from the Medical Information Contact Center (MICC).
  • Offer ongoing support and training to MICC agents and other relevant personnel regarding new or updated Medical Information content.
  • Serve as the lead medical reviewer for the Medical and/or Promotional review committee.
  • Continuously monitor the quality and accuracy of Medical Information responses, identifying necessary corrective actions or training to ensure compliance with regional and local regulations as well as internal SOPs.
  • Develop and maintain extensive knowledge of products, disease states, and competitor information within the assigned therapeutic area.
  • Mentor post-doctoral fellows, interns, and other learners.
  • Act as a Medical Information resource for internal stakeholders.
  • Ensure prompt and accurate reporting of adverse events or product complaints in line with relevant SOPs and regulations.
  • Maintain compliance with Medical Information standard operating procedures and practices.
  • Support audit readiness for Medical Information activities.
  • Adhere to all laws, regulations, and policies, including responsibilities related to adverse events and pharmacovigilance.
  • Perform additional duties as assigned.


Qualifications

Education and Experience

  • An advanced degree in pharmacy, nursing, or medicine (PharmD, NP, DNP, MD, PA) from an accredited institution is required.
  • A minimum of 3 to 5 years of experience in Medical Information or Medical Communications within a pharmaceutical company or vendor, including medical review of promotional materials.
  • Experience with product launches is preferred.
  • Completion of a pharmaceutical industry fellowship or a drug information residency is preferred.
  • Experience with rare diseases is preferred.
  • Familiarity with applicable regulatory and legal requirements for providing medical information in the pharmaceutical sector.
  • Knowledge of relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing medical information for post-marketing products.
  • Demonstrated ability to work effectively in a matrix environment.
  • Proven ability to produce clear, concise, and effective written and verbal communications that describe scientific and clinical data in English.
  • Demonstrated advanced medical information skills (e.g., literature searching, evaluation, data analysis, statistics).
  • Experience in start-up or small company environments is preferred.

Knowledge and Skills

  • Ability to cultivate strong partnerships with outsourced partners while maintaining high standards.
  • Capacity to work independently with minimal supervision, manage multiple tasks, and perform effectively under pressure; adaptability to change; excellent project management skills; attention to detail.
  • Ability to collaborate and coordinate team efforts to resolve comments and produce high-quality documents.
  • Strong interpersonal, active listening, and influencing skills; ability to establish and maintain professional relationships with team members.
  • Proficient in computer skills, particularly in Microsoft programs: Excel, Word, PowerPoint, as well as Veeva systems.
  • Fluency in English (oral and written).

Location/Travel

  • This position is based at the headquarters office.
  • Occasional domestic and international travel may be required (less than 10%).


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