Shire Associate Director Medical Information in Lexington, Massachusetts

-Ensure appropriate, quality and timely responses to requests for medical information in North America for therapeutic area of responsibility

-Support novel channels for dissemination of medical information

-Support identification and contracting of medical information providers

-Manage medical information providers

-Develop and implement medical information support materials in coordination with Global Medical Teams and Medical Communications

-Ensure reporting of potential adverse events and product issues to appropriate teams

60% of Time:

  • Ensure appropriate, quality and timely responses to Medical Information requests

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

  • Coordinate with Global Medical Teams to define and develop medical information materials (e.g. Standard Response Letters, Frequently Asked

  • Monitor performance against medical information key performance indicators

  • Support Medical Information monitoring and reporting

30% of Time:

  • Manage medical information providers

  • Collaborate with Head of North America Medical Information and Regional team members to define medical information system and vendor requirements

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

10% of Time:

  • Implement novel channels for dissemination of medical information

  • Support implementation of novel MedInfo channels

Education and Experience Requirements

  • A medical or scientific degree is required

  • 8-10 years of related work experience

  • 4 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 leading teams is preferred

  • Experience managing vendors and complex projects is required

  • Good knowledge of medical information best practices, legal and regulatory requirements, Codes of Practice, Standard Operating Practices and guidelines

Key Skills, Abilities, and Competencies

  • Focus on accountability and ownership – constantly challenging oneself to take responsibility for continuous performance improvement and operational excellence

  • Good written and verbal communication abilities, including scientific writing

  • Strong attention to detail

  • Strong scientific acumen

  • Good business acumen including budget and resource planning and management

  • Unquestionable ethics

Complexity and Problem Solving

  • Management of approved budget

  • Management of medical information vendor(s)

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

  • Position will be supported by a Medical Information Manager or Specialist in some geographies

Internal and External Contacts

  • Position is accountable to Head of North America Medical Information

  • Internal: Global Medical Teams, International Medical Affairs, Publications and Medical Communications, Medical Systems, Regulatory, Compliance, Legal, Pharmacovigilance/Safety, Technical Operations

  • External: Strategic vendor partners

Other Job Requirements

  • Availability to travel approximately 10% of time

  • Availability to participate in early or late meetings/teleconferences

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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Pay Transparency Policy -

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.