Director Medical Information

Location
Working from Home
Posted
Oct 14, 2021
Ref
329862
Hotbed
Biotech Beach
Required Education
Masters Degree/MBA
Position Type
Full time

The Director of Medical Information partners with stakeholders and cross-functional partners to successfully develop and monitor Aadi’s Medical Information strategy and objectives. The Director of Medical Information drives the development, implementation, and execution of Medical Information content and services. They also serve as a member of the medical and promotional review committees (MRC and PRC). Specific responsibilities include building the Medical Information services function and team, developing medical content for healthcare professionals and consumers, and oversight of vendor services along with implementing and tracking KPIs and metrics.

PRIMARY JOB FUNCTIONS

  • Strategic development, implementation, and execution of Medical Information content and services, including the development of an overall strategic and operational plan with the vendor responsible for the Medical Information call center
  • Management, training and supervision of Medical Information staff including call center, contractors, vendors/agencies
  • Develop and manage the Medical Information budget and liaise with financial / project management for budget planning and tracking
  • Develop and oversee the generation of timely, accurate, thorough and balanced responses to unsolicited requests for information about products from healthcare professionals and consumers consistent with regulatory guidelines utilizing appropriate information resources
  • Ensure adverse events and product quality complaints are processed in accordance with company SOPs
  • Develop and update Medical Information standard responses, FAQs and medical library with new publications, congress data, and clinical trial information
  • Provide medical information trend reports, presentations, and information to cross-functional partners and Senior Management as appropriate
  • Represent Aadi at local, regional, and national congresses and meetings as necessary
  • Participate as SME ad hoc on cross-functional committees
  • Responsible for providing medical input to the MRC and PRC
  • Provide input into policies and procedures to ensure regulatory compliance for the provision of Medical Information services to healthcare professionals and consumers, collaborating cross-functionally to align appropriate corresponding SOP(s)/guidance(s)
  • Provide input into the AMCP dossier development and lead all updates
  • Responsible for the clinical compendia strategy and submission

ESSENTIAL QUALIFICATIONS & SKILLS

  • Advanced scientific degree required
  • 6+ years of experience in the life science industry (e.g., biotech/pharmaceutical/medical device company, Contract Research Organization), academic research, or public health, including 3+ years in Oncology and medical information/medical communication experience.
  • Excellent communication, presentation and time management skills required
  • Experience with FDA audits is highly preferred
  • Experience launching novel biotech/pharmaceutical therapies is highly preferred
  • Current deep knowledge of US legal, regulatory, and compliance regulation guidelines
  • Demonstrated leadership in ambiguous situations
  • Ability to partner with key internal and external stakeholders to understand key objectives and to drive plans that achieve or exceed these objectives
  • Must be adaptable and able to work well within a team and relate effectively with people at all levels of the organization
  • Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities

OTHER REQUIREMENTS

  • This role can be performed remotely from a home office in the US
  • #LI-Remote