Senior Manager, Medical Information and MLR

Foster City

MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.

POSITION SUMMARY

As a Senior Manager of medical information and MLR, you will be responsible for the development of communications for, and fulfillment of, inquiries from US/Canada healthcare providers, patients, and others regarding Mirum’s products in accordance with all relevant regulations. These activities have a direct impact on customer service by providing clear and accurate scientific information about Mirum’s products through engagement with internal colleagues, healthcare providers, patients, and caregivers.

Additionally, you will serve the medical reviewer on the Medical-Legal-Regulatory review committee (MLR; alternately known as PRC, MRC, etc.) for one or more Mirum products.

JOB FUNCTIONS/RESPONSIBILITIES

• Serve as a product information expert; a specialist that interfaces with clients (both internally and externally) providing concise, accurate, and non-promotional responses to medical information requests in a timely manner.
• Ensure that medical information responses are accurate, clear and understandable regarding Mirum’s products and that safety, efficacy and tolerability are addressed in a fair and balanced manner.
• Support the development of medically and scientifically accurate promotional and nonpromotional materials by providing detailed, actionable feedback on all materials submitted for your review.
• Manage medical information activities for the US/Canadian market in collaboration with the global medical information lead and other team members
• Review promotional and non-promotional materials for scientific accuracy and consistency of medical messaging
• Assist call center: train call center specialists and conduct quality assessments of responses provided.
• Identify and capture adverse event information and product quality complaints.
• Assist in tracking inquiry trends and other significant issues and provide written reports of inquiry activities to VP of Medical Affairs and Sr. Leadership.
• Coordinate the use of these trends to develop and update standard response letters (SRLs).
• Develop customized response letters as necessary in response to specific inquiries.
• Assist with sales representative and medical affairs training as needed.
• Ensure the responses to inquiries are provided in an accurate, balanced and timely manner in accordance with all SOP and Regulatory guidelines globally.
• Serve as a medical information resource at scientific meetings and staffing the Medical Affairs booth when required.
• Act as information liaison with other Mirum departments and maintain current and accurate reference materials for Medical Affairs staff. These references include but are not limited to:
  • Maintain Standard Response Letters (SRL) Database
  • Maintain Clinical Library (texts, journals reprints, posters etc.)
  • Provide Medical Information literature highlights

QUALIFICATIONS

Education/Experience:

• MS, MPH, MSN, MA or Pharm
  
  D degree is required with demonstrated expertise in Medical Information.
• Demonstrated ability, or potential, to excel in smaller entrepreneurial organizations.
• A minimum of 5 years of experience in the biopharmaceutical industry, with demonstrated management and leadership abilities.
• Experience in conducting medical review for promotional materials required.
• Exceptional oral and written communication and interpersonal skills.
• Ability to understand, integrate and effectively communicate the scientific/medical and commercial value of Mirum’s products to healthcare providers and other key internal and external audiences.
• Knowledge and understanding of clinical and regulatory guidelines.
• Knowledge and understanding of compliance in medical affairs and commercial settings.
• Ability to travel up to 20% of time, to attend regional…