Global Medical Information Lead

Location
Emeryville, CA, United States
Posted
Apr 13, 2021
Ref
1068
Hotbed
Biotech Bay
Required Education
Other
Position Type
Full time
COMPANY DESCRIPTION:

Santen is a specialized pharmaceutical company with a 130-year heritage focused exclusively on ophthalmology. With sales in over 60 countries, Santen’s 4,000 global employees work to deliver life-changing therapies that make hope a reality for people facing vision impairment and loss. Santen Inc., located in Emeryville, CA (North America HQ), contributes important research & development and commercialization efforts. This office is home to about half of our 300-total staff in North America, including our Toronto, Canada site and our recent acquisitions of Eyevance Pharmaceuticals (Fort Worth, TX) and InnFocus (Miami, FL).

ABOUT THE POSITION:

The Medical Information Lead will administer. The Medical Information Lead will perform tasks related to medical information such as managing call-center, responding to inquiries escalated by the call center, leading and managing the development and training of medical information responses material such as standard response letters, FAQs, custom responses and compendia. They will execute pre-launch plan for new products, manage updates of response material and provide periodic metrics to global medical affairs. The Medical Information Lead will liaise with cross-functional teams towards the fulfillment of these responsibilities and act as the point of contact for medical information related to the product(s) .

ESSENTIAL DUTIES AND KEY DELIVERABLES:
  • Manage medical writing vendors to develop and deliver Medical Information (MI) content (Standard Response Letters [SRLs], FAQs, Compendia) for the aligned products and therapeutic areas
  • Provide authoring support for SRLs as needed
  • Develop Medical Information product plans
  • Provide periodic reports and metrics to GMA
  • Manage Medical Information documents and contents (updates/archival/retirements)
  • Provide scientific review of medical and promotional materials.
  • Manage call center
  • Participate in medical information globalization
  • Support and participate in call center audits
  • Support and participate in medical information process improvement and process implement
  • Manage Tier 2 escalated inquiries and one-off responses
  • Provide subject matter expertise (SME) and accuracy checks for medical materials review, support creation and review of both standard and custom responses
  • Support training of call center staff in all global regions through both live assistance and creation of user manuals and other training materials
  • Manage communications (internal and external) regarding product medical information deliverables. Liaise as needed with internal stakeholders to update and maintain SRLs and medical information material.
  • Manage external medical communication agencies to develop timelines and manage the process for successful execution of assigned projects
  • Work with regional Medical Affairs colleagues on a global basis to ensure consistency and efficiency of medical information responses worldwide
  • Staff the Medical Information Booth at congresses
  • Support and actively participate in activities related to globalization of Medical Information as needed
  • Ensure medical and scientific accuracy of all content deliverables
  • Ensure incorporation of customer and/or patient insight into core scientific materials where appropriate
  • Understand and continually improve upon Santen policies and procedures related the development, review, approval and use/archiving of medical materials
  • Administer the technology portal used for medical materials development and use/archiving
  • Drive medical materials through the life cycle of each document across four ophthalmologic therapeutic areas
  • Track life cycle of medical materials to ensure needed updates or expiries
  • Assist with logistical planning for Santen sponsored medical education events, including scientific symposia and scientific open houses

QUALIFICATIONS:
  • Advanced degree in life sciences
  • Minimum of 3+ years previous relevant industry experience; at least 1 year of Med Info experience
  • Familiar with many types of technology solutions, preferably as applied in the life sciences; including but not limited to: Vision Tracker, MedComms, DataVision, Tableau, and CRM
  • Self-driven, independent and motivated; proactive; can-do attitude
  • Strong organizational skills and ability to follow through with attention to detail
  • Demonstrated history of securing cross-functional input and participation at various levels of a culturally diverse organization
  • Exemplary interpersonal communication skills, both oral and written, and strong meeting facilitation skills
  • Knowledge, understanding and adherence to global regulatory guidelines (e.g. FDA, EFIPA, PDMA, JPMA, PhRMA, etc.)
  • Understanding of the regulatory and compliance environment related to Medical Affairs activities

For more information about our company and the work experience, please visit www.santenusa.com