The Medical Information Manager provides accurate, evidence-based medical information to healthcare professionals and internal stakeholders while ensuring compliance with FDA regulations and company policies. This role evaluates scientific literature, develops medical response documents, and maintains medical information resources across multiple therapeutic areas. The position collaborates with Medical Affairs, Regulatory, Pharmacovigilance, and field medical teams to support product launches, AMCP dossiers, and scientific communications. The ideal candidate combines strong scientific expertise, project management skills, and cross-functional collaboration to deliver high-quality medical information services. 

Responsibilities:

• Manage the dissemination of medical information correspondence related to various therapeutic areas (gastrointestinal related, dermatology, etc) to external customers (healthcare professionals) and internal customers (medical science liaisons, regulatory, etc) and ensure that all activities are conducted within the pharmaceutical regulatory framework.
• Oversight of performing literature searches and critically evaluates scientific data.
• Prepare standard response documents, continuously evaluate and update standard response letter database.
• Ensure projects are completed on schedule following established procedures and timelines.
• Create and review medical summary of published literature resources into standard response letter
• Interact and provide guidance to responses to the vendor call center, including providing general training 
• Work within all relevant and newly published FDA guidance relating to medical information
• Leads and/or contributes to the MI planning for new product launches, line extensions, key data releases, as applicable.
• Proactively provides logical recommendations and solutions for medical information activities
• Provides Medical Information support at conference booths, and learn the processes of booth activities
• Works cross-functionally with other Medical A team members, as necessary airs, Regulatory, Pharmacovigilance matrix
• Understand and execute on AMCP Dossier requests while interacting with HEOR and field medical teams, as needed
• Assist with ad-hoc Medical A oversight from manager airs projects- Plans and coordinates projects with minimal
• Business travel (approx.10%) may be required for support at Medical Affairs scientific congresses and/or internal meetings 

Qualifications:

• Bachelors degree required. Advanced degree (such as PharmD,PhD, etc) in the sciences is preferred
• Fellowship in Medical Information or minimum of 2 years of related experience in a Medical Information department within the pharmaceutical industry is preferred.
• Excellent verbal, written, and interpersonal skills are required
• Must be able to consistently perform work requiring a high level of attention to detail
• Excellent task management skills including planning, prioritization, objective setting, and meeting management are strongly preferred
• Ability to provide high level professional support to the management team and to establish effective working relationships with a diverse range of stakeholders
• Demonstrate critical thinking skills with ability to anticipate issues and impact on related areas of an event or project
• Proficiency in Microsoft Excel, PowerPoint and Word and a strong working knowledge of databases 

The range of starting base pay for this role is 128K – 176K.  Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.

Benefits package includes a comprehensive Medical (includes Prescription Drug), Dental, Vision, Flexible Spending Accounts, 401(k) with matching company contribution, discretionary time off, paid sick time, stock purchase plan, tuition reimbursement, parental leave, short-term and long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, employee referral bonuses and employee discounts.