Shire Medical Information Manager NA in Lexington, Massachusetts

-Develop and communicate appropriate, quality and timely responses to requests for medical information in NA

-Develop and implement medical information support materials

-Report potential adverse events and product issues to appropriate teams

-Support management of medical information providers

70% of Time:

  • Develop and communicate appropriate, quality and timely responses to Medical Information requests

  • Internally or in collaboration with Medical Communications and Global Medical Teams, develop and communicate timely, accurate responses to unique and escalated inquires

  • Develop medical information materials (e.g. Standard Response Letters, Frequently Asked Questions)

30% of Time

  • Support management of medical information providers

  • Manage compliant delivery of vendor services, including call center setup and implementation, ongoing training and reporting

  • A medical or scientific degree is required

  • 5-7 years of related work experience required

  • 2 years of experience in the biopharmaceutical industry, preferably within a matrix structure is required

  • 2 years of experience within medical affairs, clinical research or PV/safety roles (e.g. Medical Information, Medical Communications, Pharmacovigilance/Safety)

  • Experience managing projects is preferred

  • Knowledge of medical information best practices, legal and regulatory requirements, Codes of Practice, Standard Operating Practices and guidelines is preferred

Key Skills, Abilities, and Competencies

  • Focus on accountability and ownership

  • Good written and verbal communication abilities, including scientific writing

  • Strong scientific acumen

  • Strong attention to detail

Complexity and Problem Solving

  • Development of Medical Information materials in alignment with Global Medical Team and regional requirements

Internal and External Contacts

  • Position is accountable to the Regional Medical Information or Regional SMS Lead

  • Internal: Publications and Medical Communications, Regulatory, Compliance, Legal, Pharmacovigilance/Safety, Technical Operations

  • External: Strategic vendor partners

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.